Latest Pharma GMP News and Regulatory updates
We publish the latest GMP news every week. This weekly GMP news consists of newly published FDA Guidelines, EMA Guidelines, MHRA Guidelines, and guidelines from other regulatory authorities.
The weekly GMP news post aims to share consolidated updates with the pharmaceutical professionals and keep tech-publish.com readers updated with current regulatory requirements. In addition, the GMP news consists of source and reference links so that readers can reach respective organizations’ or authoritys’ websites.
Keywords: GMP news, GMP news today, newly published GMP guideline, FDA guidelines, Pharmaguidelines, GMP guidelines, EMA guidelines, MGRA guidelines
Latest Pharma GMP News and Regulatory updates
Pharma GMP News of the Week: 26-Oct-2023
Period: Aug 1, 2023 to Sep 30, 2023
CDSCO Clarifies QR Code Requirements for Top 300 Medicine Brands in India
Date: July 21, 2023
India’s CDSCO has clarified the new requirement for manufacturers of the top 300 medicine brands to add a barcode or QR code to their product labels by 1 August 2023. The codes, which can be printed on secondary labeling in certain circumstances, will carry information such as the unique product identification code and expiry date. The requirement applies to all indigenous and foreign manufacturers marketing these brands in India. Despite previous delays in regulatory requirements, this requirement is set to be implemented as planned.
EMA Overhauls Q&A Document on Clinical Trial Data Publication
Date: July 26, 2023
The European Medicines Agency (EMA) has updated its Q&A document on the publication of clinical trial data, adding 10 new questions. The update aims to help applicants and marketing authorization holders comply with the clinical data publication policy. Key clarifications include the scope of the policy, the process for additional redactions to protect study unmasking/unblinding, and the potential for joint review/publication with Health Canada. EMA also acknowledges the need for further guidance on managing the publication of clinical study reports under both Policy 0070 and the Clinical Trial Regulation.
Swiss-US Mutual Recognition Agreement on Manufacturing Practices Activated
Date: July 27, 2023
The Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA) between Switzerland and the US is now in effect. The FDA and Swissmedic have found each other’s processes for monitoring medicinal product manufacturers to be comparable. This allows them to accept the results of each other’s GMP inspections. Before conducting an inspection, it will be checked if the production site has already been inspected. If so, GMP documents will be shared for evaluation, potentially avoiding an on-site inspection.
Source: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/inkrafttreten-mra-swissmedic-fda.html
Philippine FDA Proposes Incorporation of WHO Guidelines for Postapproval Changes to Vaccines and Biotherapeutics
Date: July 31, 2023
The Philippine FDA is proposing to incorporate WHO guidelines on postapproval changes to vaccines and biotherapeutics into its own rules. The FDA has released a draft circular outlining the revised requirements and application process for these changes. The circular defines key terms and provides implementing details, including the classifications of variations. The FDA aims for all postapproval changes to be based on the latest WHO guidelines and country-specific regulations. The new guidelines will apply to all future postapproval change submissions.
MHRA Issues New Brexit Guidance on Labeling and Packaging of Medicines
Date: August 2023
The UK’s MHRA has released guidance on labeling and packaging of medicinal products under the Windsor Framework, which revises Brexit terms. From 2025, all UK medicinal products must carry a “UK Only” label. The MHRA will allow medicines in legacy EU packaging until the end of 2024. The “UK Only” statement can be applied using a sticker until mid-2025, after which it must be printed directly onto the packaging. The guidance also discusses the disapplication of the Falsified Medicines Directive from Northern Ireland.
MHRA Clarifies Exclusion of Medical Devices from UK’s CE Mark Recognition
Date: August 01, 2023
The UK’s MHRA has clarified that the government’s decision to indefinitely recognize the CE mark does not apply to medical devices. As part of Brexit, the UK created the UKCA, its equivalent of the CE mark. Despite the recent announcement of indefinite recognition of the CE mark to prevent uncertainty and unnecessary costs, this does not extend to medical devices or IVDs. The transition from the CE mark to UKCA still applies to these devices, with the UK set to stop accepting CE-marked medical devices between 2028 and 2030.
Source:
FDA Finalizes Guidance on DSCSA Waivers, Exceptions, and Exemptions
Date: August 04, 2023
The FDA has finalized its guidance on the process for granting or denying waiver, exception, and exemption (WEE) requests under the Drug Supply Chain Security Act (DSCSA). The guidance, which finalizes a draft issued in 2018, also outlines the biennial review process for previously approved WEEs. Changes include a requirement for electronic submission of requests and new sections on how to request reconsideration of the scope of a granted WEE or a denied request. The guidance specifies that WEEs will be reviewed every two years to assess if material changes in circumstances warrant their continuation.
Source: https://www.fda.gov/media/113342/download
FDA Establishes Acceptable Intake Limits for Nitrosamines in Drugs
Date: August 04, 2023
The FDA has issued a final guidance setting acceptable intake (AI) limits for nitrosamine drug substance-related impurities (NDSRIs) in drug products and active pharmaceutical ingredients (APIs). Manufacturers are called upon to evaluate NDSRI risks within three months and complete assessments by 1 November 2023. By 1 August 2025, any NDSRIs in drug products should meet the FDA-recommended AI limit. The guidance outlines a three-step mitigation strategy for assessing the presence of NDSRIs and introduces a methodology for assigning a recommended AI limit to an NDSRI. The AI limit approximates an increased cancer risk of one additional case in 100,000 people based on daily exposure to the impurity over a lifetime.
Source: https://www.fda.gov/media/170794/download
Online Retail Platforms in India Deny Responsibility for Non-Compliant Medicine Trade
Date: August 08, 2023
Online retailers in India have denied responsibility for the sale of non-compliant medicines, stating they are merely intermediaries connecting customers and licensed pharmacies. This comes after the Central Drugs Standard Control Organization (CDSCO) sent show-cause notices to various firms involved in online drug sales. The Indian government has drafted rules for the sale and distribution of medicines online, which include provisions for registering and inspecting e-pharmacies, a procedure for online drug distribution or sale, and a ban on advertising drugs through e-pharmacies.
Source: https://pib.gov.in/PressReleasePage.aspx?PRID=1946709
FDA Drafts Guidance on Classification Categories for Biosimilar Supplements
Date: August 11, 2023
The FDA has published draft guidance to assist sponsors in determining the appropriate supplement category for biosimilar applications and outlines the review process. The guidance covers six classification categories for supplements, established under the Biosimilar User Fee Amendments of 2022 (BsUFA III). These categories range from Category A, for straightforward changes incorporating safety labeling updates, to Category F, reserved for supplements seeking an initial determination of interchangeability. The review goals will vary depending on the type of supplement, with safety updates reviewed faster than those adding new efficacy data. The guidance aims to ensure consistent review processes across divisions.
Source: https://www.fda.gov/media/170906/download
FDA Updates Draft Guidance for Biosimilar Meetings Under BsUFA III
Date: August 11, 2023
The FDA has published a revised draft guidance to assist biosimilar developers in convening meetings with the agency. The guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products”, replaces a previous draft from June 2018. Changes include modifications to data expectations in Biosimilar Initial Advisory meeting requests, the addition of Biological Product Development Type 2a meetings, and updates to available meeting formats. The guidance outlines five types of formal meetings for discussing the development and review of a biosimilar or interchangeable product. The FDA emphasizes the importance of efficient, consistent procedures for conducting these meetings.
Source: https://www.fda.gov/media/113913/download
FDA updates Guidance on OTS Software for Medical Devices
Date: August 11, 2023
The FDA has updated a final guidance on off-the-shelf (OTS) software used in medical devices, aiming to reduce administrative burdens for sponsors. The updated guidance moves away from the hazard analysis approach of the 2019 version, instead asking sponsors to conduct an OTS software risk assessment and provide varying levels of documentation based on potential risk. The guidance relies on a previous premarket submission guidance on medical device software and asks sponsors to submit a risk management file and plan. The updated guidance aligns more closely with the FDA’s broader approach to medical device software and international consensus standards.
Source: https://www.fda.gov/media/71794/download
Indian Medtech Industry Challenges Proposed Reform Bill
Date: August 2023
The Association of Indian Medical Devices Industry (AiMeD) has expressed concerns about a bill set to repeal the Drugs and Cosmetics Act, 1940. AiMeD has criticized the bill for being unreasonable and unimplementable, arguing that it was created without involving medical device regulatory specialists. The group has raised issues such as the excessive threat of imprisonment for noncompliance, lack of patient safety considerations, and the legalization of “pseudo manufacturing”. AiMeD also criticized the application of pharma-centric rules to the medtech sector and compared the Indian proposal unfavorably to international regulatory frameworks. The group is pushing for major changes to the proposals.
Source: https://twitter.com/MiIAiMeD/status/1690189972131696641
PMDA Updates Consultation Process for Industry Guidance
Date: August 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has revised its consultation process to provide more comprehensive guidance to industry stakeholders. The new process includes three types of consultations for early-stage projects: general consultation, pre-consultation meetings, and full scientific discussions. While the first two types are free, a fee applies to full consultations. However, PMDA offers a 90% fee reduction for certain qualifying applicants. This update aims to provide clearer and more supportive guidance to companies in the early stages of product development.
Source: http://pmda.go.jp/english/review-services/consultations/0002.html
New Zealand Updates Guidelines on Acceptable Overseas Evidence of GMP
Date: August 2023
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published an updated version of its guidelines on the manufacture of medicines. The update clarifies examples of acceptable evidence from audits by authorities in the United States and European Union. The guidelines now include a broader list of recognized authorities and provide more information about using evidence from FDA audits. Medsafe also clarified the requirements for certificates published in EudraGMP, the EU’s database of manufacturing authorizations and certificates of GMP compliance.
Source: https://medsafe.govt.nz/regulatory/Guideline/GRTPNZ/manufacture-of-medicines.pdf
India Releases New Policy to Boost R&D and Innovation in Pharma-Med Tech Sector
Date: August 18, 2023
India’s Department of Pharmaceuticals (DoP) has unveiled the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector. The policy aims to create a regulatory environment that encourages innovation and research in product development. It proposes four measures: process optimization, technology-based platform, regulatory capacity enhancement, and legislation review. The goal is to reduce approval times for innovative products by at least 50% within two years, enhance transparency and predictability, build in-house expertise in emerging areas, and identify legislative friction points. The policy is published alongside the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), which aims to strengthen the country’s research infrastructure.
Boosting EU-UK Medicine Trade through Greater Mutual Recognition
Date: August 2023
The European Parliamentary Research Service (EPRS) suggests that greater mutual recognition of product rules and conformity assessments between the EU and UK could enhance trade, including medical products. Post-Brexit, the UK sought to establish its own rules, leading to trade barriers. EPRS’s report assesses the EU-UK Trade and Cooperation Agreement’s effects, noting that while it has facilitated trade, new barriers have emerged due to lack of mutual recognition of regulations. The UK has paused plans to implement its own standards in some areas but is proceeding with an alternative to the EU’s CE mark for medical devices. EPRS recommends further steps to lower trade barriers, especially in sectors like automation, finance, agriculture, and medicine. The feasibility of mutual recognition will depend on how the UK uses its freedom to set its own rules.
Source: https://www.europarl.europa.eu/RegData/etudes/STUD/2023/747433/EPRS_STU(2023)747433_EN.pdf
FDA Delays DSCSA Track and Trace Requirements by One Year
Date: August 28, 2023
The US FDA has granted a one-year reprieve from DSCSA requirements for system-wide electronic interoperable systems for tracking products through the supply chain. Originally due by 27 November 2023, enforcement will now begin on 27 November 2024. The FDA emphasizes that this should not delay efforts to implement enhanced drug distribution security requirements. The decision responds to stakeholders’ concerns about readiness and the complexities of implementing DSCSA. The FDA also will not enforce the requirement for systems and processes to accept saleable returns.
Source:
https://www.fda.gov/media/171592/download
https://public-inspection.federalregister.gov/2023-18359.pdf
WHO Urges Pharmaceutical Labs to Prepare for Operational Disruptions
Date: August 2023
The World Health Organization (WHO) has updated its guidelines for pharmaceutical control labs, first issued in 1999, urging them to maintain crisis management plans. The update includes a new section on strategic planning and revisions to sections on performance evaluation, risk management, crisis management, communication management, and measurement uncertainty. The guidelines now apply to all pharmaceutical quality control labs, not just national ones. Labs are advised to create a business continuity plan, analyze potential risks, and establish recovery strategies. These plans should be tested regularly and disseminated among all involved parties.
Source: https://www.who.int/
FDA Issues Additional Guidance on DSCSA Electronic Tracking Requirements Delay
Date: August 30, 2023
The US FDA has published two additional guidances detailing the one-year extension from enforcement of requirements for electronic product tracking under the Drug Supply Chain Security Act (DSCSA). The guidances are part of the FDA’s plan to extend the DSCSA deadline, allowing trading partners to develop and refine their electronic systems. One guidance describes enhanced drug distribution security requirements for DSCSA at the package level, while the other outlines compliance policies for wholesale distributors and dispensers on product identifier verification. The FDA does not intend to take action against wholesale distributors who do not comply with certain DSCSA requirements if they do not have compliance systems in place.
Source:
Australia’s New Policy on Injectable Product Information
Date: August 30, 2023
Starting from 1st September, Australia’s Therapeutic Goods Administration (TGA) has ceased the requirement for manufacturers to include printed product information in the packaging of injectable products administered by healthcare professionals. This decision was based on feedback received by TGA, weighing the environmental impact and the risk of outdated information against the benefits of hard copies. However, injectables administered by patients or carers will still include printed information. The policy aims to ensure safety and minimize waste, while also considering the potential increase in package size due to hard copies. Some products already in the market will continue to have printed package inserts.
MHRA’s Revised Pharmacovigilance Compliance Model and Its Impact on Inspection Findings
Date: September 04, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a revised good pharmacovigilance practice (GPvP) inspection model in the 2020 to 2021 financial year. The model aims to facilitate the selection of appropriate pharmacovigilance systems, products, and non-interventional studies for inspection. A significant area of focus in the inspection findings was risk management, with findings spread across all subtopics, emphasizing the importance of managing risk throughout the product lifecycle and across critical pharmacovigilance processes. MHRA plans to continue applying a risk-based approach to inspection scheduling, prioritizing visits based on product risk profile, complexity of pharmacovigilance systems, and intelligence from various sources. Inspections will be conducted either on-site or remotely based on several factors.
FDA’s Draft Guidance on Post-Warning Letter Meetings under GDUFA III
Date: September 05, 2023
The US Food and Drug Administration (FDA) has issued a draft guidance outlining the process for post-warning letter meetings under the Generic Drug User Fee Amendments (GDUFA III). The guidance details how facilities can request a meeting with the FDA to discuss corrective actions for good manufacturing practice deficiencies. These meetings, which may be conducted via video conference, teleconference, or face-to-face, are generally scheduled six months after the facility’s initial response to the FDA warning letter. However, earlier meetings may be granted if beneficial. The guidance emphasizes that these meetings do not halt FDA regulatory actions and that the advice provided is not binding on the agency. Facilities are required to submit electronically a complete meeting package, including a corrective and preventive action plan and supplementary information demonstrating systemic remediation of deficient practices. The FDA maintains the right to deny meeting requests for various reasons, including inadequate remediation progress or incomplete meeting packages.
Source: https://www.fda.gov/media/171785/download
FDA Finalizes Guidance on Tracing Products Through Supply Chain”
Date: September 06, 2023
The US Food and Drug Administration (FDA) has finalized its guidance on the use of electronic standards for tracing products through the pharmaceutical supply chain. The guidance allows trading partners to use portals and email exchanges for tracking drug products, particularly benefiting smaller pharmacies that may lack encrypted internet connections for exchanging Electronic Product Code Information Services (EPCIS) information. This decision comes in response to requests from industry groups, including the Association for Accessible Medicines (AAM), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Healthcare Distribution Alliance (HDA). The guidance is largely in line with the Drug Supply Chain Security Act (DSCSA) requirements, which mandate enhanced drug tracking from 27 November 2023. However, the FDA recently announced a one-year delay in implementing these requirements.
Source: https://www.fda.gov/media/171796/download
MHRA’s Business Plan to Eliminate Backlogs and EMA’s Proposed Changes for Depression Treatments
Date: September 07, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has committed to clearing its current service backlogs by the end of the fourth quarter of the 2023-2024 financial year. This is part of MHRA’s business plan, which includes identifying service improvements, eliminating backlogs, delivering phase one of an innovation-enabling and risk-proportionate medicines compliance strategy, and fully embedding the new SafetyConnect vigilance system.
In other news, the European Medicines Agency (EMA) has published draft guidelines on the clinical investigation of medicinal treatments for depression. The document has been rewritten and restructured to reflect changes in the treatment and drug development landscape since its finalization in 2013.
FDA Proposes 510(k) Program Modernization with New Draft Guidances”
Date: September 07, 2023
The US Food and Drug Administration (FDA) is taking steps to modernize the 510(k) program, which includes updates to its Safety and Performance Based Pathway and electronic Submission Template And Resource (eSTAR) program. From October 2023, non-exempt 510(k) submissions must be submitted through eSTAR. The FDA has also released three new draft guidance documents concerning different aspects of the 510(k) program. The first addresses best practices for selecting a predicate device, the second expands FDA’s policies on when clinical data on substantial equivalence is necessary in a 510(k) submission, and the third provides evidentiary expectations for 510(k) devices. These steps aim to enhance predictability, consistency, and transparency in the use of clinical data in 510(k) submissions.
European Commission Seeks Feedback on Postmarket Variation Framework Improvement
Date: September 2023
The European Commission is soliciting feedback on how to enhance the postmarket variation framework for medicines. This initiative aims to bridge the gap until the implementation of changes through the revision of general pharmaceutical legislation. The Commission seeks to reduce the administrative burden for marketing authorization holders and authorities, thereby freeing up resources currently consumed by the large number of variations. The initiative may include re-classifying some variations into lower categories and/or introducing additional flexibility, particularly regarding the level of technical information required. The Commission aims to enable marketing authorization holders to introduce timely manufacturing or quality improvements, embracing new technologies and digitalization approaches. Submissions are open until 26 September.
Source: https://eur-lex.europa.eu/
FDA issued guideline on “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
Date: September 08, 2023
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility considerations for medical device sponsors in their premarket submissions. The updated guidance now includes a list of certain synthetic polymers and natural fabrics that are exempt from biocompatibility requirements. These materials, which FDA believes pose a very low biocompatibility risk due to their long history of safe use, include 24 polymers and three fabrics. Sponsors are encouraged to suggest other materials for inclusion in the list. The FDA plans to periodically reassess the list and has recommended the use of its Q-Submission process for early discussions about the use of listed materials in specific products.
Source: https://www.fda.gov/media/142959/download
FDA Launches CMC Development and Readiness Pilot for Expedited Drugs”
Date: September 11, 2023
The US Food and Drug Administration (FDA) has announced a limited chemistry, manufacturing, and controls (CMC) development and readiness pilot (CDRP) program to facilitate the development of breakthrough or accelerated review products. The pilot aims to enhance CMC readiness for selected products with accelerated clinical development timelines, increase communication between FDA and sponsors, and provide patients with earlier access to these products. Under the pilot, FDA will offer product-specific CMC advice during product development, additional CMC-focused Type B meetings, and a limited number of extra CMC-focused discussions. Sponsors interested in participating should submit a request as an amendment to their Investigational New Drug (IND) application. The FDA will select nine applications for the pilot, with two-thirds of these products from the Center for Biologics Evaluation and Research (CBER) and one-third from the Center for Drug Evaluation and Research (CDER).
Source: https://www.regulations.gov/document/FDA-2022-N-2396-0004
TGA Initiates Medical Devices Vigilance Pilot Program”
Date: September 11, 2023
Australia’s Therapeutic Goods Administration (TGA) is launching a pilot program aimed at improving the monitoring of medical device performance and enhancing product safety oversight. The voluntary program, which will run for 12 months, offers sponsors the opportunity to work with TGA and gain a better understanding of their post-market regulatory requirements. Participants are expected to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT), which will be used by TGA to select sponsors for desktop audits, onsite inspections, or both. The initiative is designed to support regulatory education and compliance, and the insights gathered will contribute to the ongoing development of the program and enhance the safety of Australian patients using medical devices.
Source: https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot
Medsafe’s Overview on Supply Restrictions of Controlled Drugs”
Date: September 2023
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released an overview of the restrictions on the supply of controlled drugs. The report explains that due to their potential for harm, some products are subject to additional supply restrictions. Supply of controlled drugs requires individual approval from the New Zealand Minister of Health, unless an exemption or blanket approval is in place, and each consignment needs a Licence to Import Controlled Drugs. The requirements vary between different products. For instance, supply of lysergic acid requires ministerial approval, while medicinal cannabis is exempt from this requirement but is still classified as a controlled drug. Some other molecules, including ephedrine, are covered by blanket approvals.
Source: https://medsafe.govt.nz/profs/PUArticles/PDF/Prescriber-Update-44-No.3-September-2023.pdf
Japanese Pharmacopoeia Drafts Monograph on Diagnostic Dye for Public Consultation”
Date: September 2023
The Japanese Pharmacopoeia (JP) has released a draft monograph for public consultation on indocyanine green, a dye used in various medical applications such as cardiac output tests, liver function tests, and eye procedures. The draft monograph provides details on how to identify the molecule, along with information on appropriate containers and storage conditions. Feedback on the draft is being accepted until November 30. This move by JP is aimed at updating its position on the dye, complementing the existing reference standard provided by the US Pharmacopeia.
Source: https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/pub-comments/jp/0036.html
EMA’s Revised Guidelines for Depression Treatments and Pharma’s Meeting with Ukrainian Government”
Date: September 11, 2023
The European Medicines Agency (EMA) has published draft guidelines on the clinical investigation of medicinal treatments for depression. The guidelines have been rewritten and restructured to reflect changes in the treatment and drug development landscape. The draft covers the definition and identification of partial and non-responders, the design of trials for patients with treatment-resistant depression, and the clinical development requirements for targeting sub-domains of depression. Additionally, EMA has added sections on rapid-acting antidepressants and psychedelics.
In other news, pharmaceutical trade groups have met with the Ukrainian government to discuss the creation of an independent regulatory agency. The meeting covered the need for transparent and efficient regulatory processes, the creation of independent regulatory and health technology assessment bodies, restarting clinical trials in Ukraine, and an agreement on manufacturing inspections. These actions aim to improve Ukraine’s regulatory environment and prepare the country for potential accession to the EU.
FDA’s Draft Guidance on Clinical Pharmacology and Labeling for Peptide Drug Products
Date: September 11, 2023
The US Food and Drug Administration (FDA) has released a draft guidance outlining clinical pharmacology and labeling considerations for peptide drug products. The guidance, intended to assist industry in the conduct of development programs, covers the definition and identification of partial and non-responders, the design of trials for patients with treatment-resistant depression, and the clinical development requirements for targeting sub-domains of depression. Additionally, it includes sections on rapid-acting antidepressants and psychedelics. The FDA has yet to set dates for the start and end of the consultation.
MedTech Europe Advocates for Structural Reform of MDR and IVDR
Date: Sep 14, 2023
MedTech Europe and 34 national associations have called on the European Union (EU) Commissioner for Health to implement comprehensive structural reforms to address challenges created by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The trade groups argue that the regulations have failed to provide a robust, transparent, predictable, and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation. They propose three main reforms: a more efficient and fit-for-purpose CE marking system; a system that supports medtech innovation; and a single structure that oversees and manages the regulatory system. The groups are urging the EU to formally elevate the need for comprehensive structural reform within Europe’s health policy debates.
FDA’s Breakthrough Devices Guidance Now Includes Technologies Addressing Health Disparities
Date: September 15, 2023
The US Food and Drug Administration (FDA) has updated its guidance on the breakthrough device program to include technologies that benefit populations impacted by health care disparities. The update also adds criteria for deciding whether a device provides a “more effective” treatment and expands the program’s criteria to include non-addictive products for treating pain or addiction. The FDA has adopted most of the changes proposed in a draft guidance issued last October. Since the launch of the breakthrough program in 2018, the FDA has granted breakthrough status to 839 devices.
Source: https://www.fda.gov/media/162413/download
FDA’s Final Guidance on Medical Device Voluntary Improvement Program
Date: September 15, 2023
The US Food and Drug Administration (FDA) has finalized its guidance for the Voluntary Improvement Program (VIP), a program managed by the Medical Device Innovation Consortium (MDIC) that uses an appraisal similar to the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. The guidance clarifies that the VIP is not a regulatory inspection or audit, and it does not replace FDA inspections. The program can be used to benefit populations impacted by health care disparities. The FDA has also added new criteria for deciding whether a device provides a “more effective” treatment and expanded its criteria to include non-addictive products for treating pain or addiction.
FDA Seeks Stakeholder Input on Quality Management Maturity Program
Date: September 15, 2023
The US Food and Drug Administration (FDA) is seeking stakeholder input as it develops a voluntary Quality Management Maturity (QMM) program. The program aims to create a strong quality culture mindset, recognize firms with advanced QMM practices, target areas for improvement, and minimize risks to product availability. Trained assessors would conduct the QMM assessments, covering five practice areas including management commitment to quality, business continuity, advanced pharmaceutical quality systems, technical excellence, and employee engagement and empowerment. The FDA is seeking input on various aspects of the program, including anticipated advantages, benefits of participation, potential unintended consequences, and the content of QMM reports. The deadline for commenting is December 14.
FDA’s Final Guidance on Acceptable Confirmatory Evidence for Medical Devices
Date: September 19, 2023
The US Food and Drug Administration (FDA) has released a draft guidance outlining the types of confirmatory evidence it will accept from sponsors seeking to demonstrate the effectiveness of their medical devices using one adequate and well-controlled clinical investigation. The guidance, which aims to accommodate more products for serious diseases lacking effective treatments, includes seven types of acceptable confirmatory evidence. These include clinical evidence from a related indication, mechanistic or pharmacodynamics evidence, evidence from a relevant animal model, evidence from other members of the same pharmacologic class, evidence from natural history, real-world data/evidence, and evidence from expanded use of an investigational drug. The FDA emphasizes that this list is not exhaustive and that the quality and quantity of confirmatory evidence are important considerations.
IMDRF’s Updated Guidance on Personalized Medical Devices
Date: September 2023
The International Medical Device Regulators Forum (IMDRF) has published a guidance on Personalized Medical Devices (PMDs), aiming to harmonize how different regulatory bodies oversee such devices. The guidance defines three categories of PMDs: custom-made medical devices, patient-matched medical devices, and adaptable medical devices. It provides general requirements to identify each category, and manufacturing and record-keeping requirements to ensure manufacturing consistency and that the products are trackable. The IMDRF emphasizes that this guidance is intended to accommodate more products for serious diseases that lack effective treatments, and to advance health equity.
MHRA’s Innovative Devices Access Pathway for Accelerated Access to Medical Technologies
Date: September 19, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Innovative Devices Access Pathway (IDAP), a new program designed to expedite access to innovative medical technologies. The IDAP, first announced in May 2023, offers support and benefits such as system navigation advice, priority clinical investigation, assistance with health technology assessment adoption, and exceptional use authorization if safety standards are met. The program is open to medical technologies that address significant unmet needs and are yet to receive regulatory approval or clearance. Applicants must provide proof-of-concept data on a near-final prototype and have already sought clinical input from at least one UK health organization or medical charity. Applications for the IDAP pilot are being accepted until October 29.
Source: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap
EMA’s Clarifications on Biological Medicinal Products
Date: September 2023
The European Medicines Agency (EMA) has published a question-and-answer document addressing various aspects of biological medicinal products. The document, created by EMA’s Biologics Working Party, answers 14 questions on topics such as process validation, biosimilars, and polysorbate testing. Key clarifications include that routine testing for process-related impurities is not necessary if consistent elimination has been demonstrated by validation studies, and characterization results of the reference product may be used for clinical justification of the specification limits of a biosimilar. Additionally, if degradation is a risk, manufacturers should include a test for polysorbate in both the routine release and stability specifications.
FDA’s Guidance on Labeling of Drug Use-Related Software Outputs
Date: September 19, 2023
The US Food and Drug Administration (FDA) has released draft guidance on how to include software outputs of drug use-related software in prescription labeling. The guidance defines prescription drug use-related software and considers end-user output from such software as a type of prescription drug labeling. The FDA has provided specific recommendations on what to include in the prescribing information for drug use-related software. The guidance is intended to align with initiatives across all product centers, including digital health initiatives, and does not alter the current regulatory framework.
Source: https://www.fda.gov/media/172165/download
FDA Guidance on Formal Meetings Adds New Categories, Timelines
Date: September 22, 2023
The US Food and Drug Administration (FDA) has issued revised draft guidance to help sponsors understand the different types of meetings they can request for questions related to their applications and describes the timelines associated with these requests. The guidance, announced on 21 September 2023, adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings. The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This draft guidance replaces an earlier version issued in December 2017. Comments can be submitted until 21 December 2023.
Source: https://www.fda.gov/media/172311/download
FDA to Continue Using Remote Inspection Tools for Pending Applications
Date: September 22, 2023
The US Food and Drug Administration (FDA) has issued a draft guidance formalizing its plans to use alternative tools, including remote regulatory assessments (RRA) and remote interactive evaluations (RIE), to assess drug manufacturing facilities’ compliance with good manufacturing practices (GMPs). This approach, which was successful during the COVID-19 pandemic, will continue to be used when appropriate. The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), but excludes post-approval inspections and other types. FDA will consider various factors in deciding whether to inspect onsite or use alternative methods. While participation in an RRA is mandatory, an RIE is voluntary. Non-compliance may result in delayed action on the application or a complete response letter (CRL) to the manufacturer.
Source: https://www.fda.gov/media/172290/download
FDA’s IT Strategy Focuses on Modernization and AI
Date: September 2023
The US Food and Drug Administration (FDA) has published its Information Technology Strategy for Fiscal Years 2024 to 2027. The strategy emphasizes modernization, integration of ecosystems across the agency, improved data sharing, adoption of new technologies, and investment in talent and leadership. The FDA aims to create a “shared OneFDA ecosystem” for enhanced collaboration and communication, promote transparency, optimize investments, and strengthen governance. The strategy also includes improving the IT infrastructure through modernization efforts, adopting a “Zero Trust” approach for cybersecurity, enabling broad-level data sharing, analyzing the potential and risks of emerging technologies like AI, and building a team of experts to keep the agency at the forefront of IT changes. This strategy represents a shift from an Office of Digital Transformation (ODT)-only IT strategy to an enterprise IT strategy designed in collaboration with FDA’s Center and Office partners.
Source: https://www.fda.gov/media/172067/download?attachment
Pharma GMP News of the Week: 18-Oct-2023
Period: May 21, 2023 to Jul 31, 2023
FDA published guideline on “Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information”
Date: May 24, 2023
FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. This guidance describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications (NDAs) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)) and biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). The information that supports the nonclinical safety of a drug and that must be submitted in the application can include references to GASK, when appropriate, instead of or in addition to, specific studies conducted with respect to the drug. In such cases, therefore, it might be unnecessary to conduct certain nonclinical studies.
Source: https://www.fda.gov/media/168408/download
FDA published guideline on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products”
Date: May 26, 2023
This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials. The main focus of the guidance is on the use of prognostic baseline covariates to improve statistical efficiency for estimating and testing treatment effects. This guidance does not address use of covariates to control for confounding variables in non-randomized trials, the use of covariates in models to account for missing outcome data (National Research Council 2010), the use of covariate adjustment for analyzing longitudinal repeated measures data, the use of Bayesian methods for covariate adjustment, or the use of machine learning methods for covariate adjustment.
Source: https://www.fda.gov/media/148910/download
FDA published guideline on “Migraine: Developing Drugs for Preventive Treatment”
Date: May 26, 2023
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. Pharmacological approaches to the treatment of migraine include drugs to abort migraine attacks as they arise (acute treatment of migraine) and drugs to reduce the frequency of migraine attacks (preventive treatment). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support approval of drugs for the preventive treatment of migraine. This guidance does not address the development of drugs indicated for the acute treatment of migraine. Such development has been addressed in the guidance for industry Migraine: Developing Drugs for Acute Treatment (February 2018).
Source: https://www.fda.gov/media/168871/download
MHRA has published blog on its website on ICH E6 (R3) Good Clinical Practice
Date: May 26, 2023
Source: https://mhrainspectorate.blog.gov.uk/2023/05/26/ich-e6-r3-good-clinical-practice/
FDA published guideline on “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions”
Date: June 05, 2023
This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence2 to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances.
Source: https://www.fda.gov/media/154762/download
FDA published guideline on “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals”
Date: June 05, 2023
The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of pharmaceuticals. Immunotoxicity is, for the purposes of this guidance, defined as unintended immunosuppression or stimulation (including hypersensitivity), which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators. This guidance applies to drug products, including small molecule drugs and oligonucleotides, as well as certain biological products such as biotechnology-derived therapeutic proteins (referred to herein as biopharmaceuticals). For the purposes of this guidance, the term pharmaceutical will be used as a general term that encompasses all of these product types. Cell and gene therapies, adjuvanted vaccines, and blood products are not within the scope of this guidance.
Source: https://www.fda.gov/media/169117/download
FDA published guideline on its website “E6(R3) GOOD CLINICAL PRACTICE (GCP)”
Date: June 06, 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Guideline for Good Clinical Practice.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety and the reliability of trial results. This draft guidance encourages innovation, focuses on quality, and establishes proportionate and risk-based approaches for conducting clinical trials, while minimizing unnecessary complexities. The draft guidance is intended to provide flexible, modern, and clear Good Clinical Practice for conducting clinical trials
Source: https://www.fda.gov/media/169090/download
News from EDQM “EDQM publishes 2nd edition of Herbal Guide”
Date: June 07, 2023
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users of the European Pharmacopoeia (Ph. Eur.) to understand the principles behind the drafting and revision of herbal monographs.
This 2nd edition of the Guide, as approved by the Ph. Eur. Commission at its 175th session, has been completely overhauled and updated to reflect the latest versions of the relevant monographs and to take account of new Ph. Eur. texts published since the first edition was issued in 2005. For example, the sections on ‘Assay’ and ‘Herbal drug preparations’ have been substantially revised and expanded and the guide also includes new and useful information such as an example schematic drawing of the characteristic microscopic features of a powdered herbal drug and a section on identification by HPTLC (in accordance with general chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations). A new section referring to the recently implemented general chapter 2.8.26. Contaminant pyrrolizidine alkaloids – compounds found naturally in many common weeds that may adulterate herbal drugs – has also been added.
The Guide, together with other Ph. Eur. technical guides, is available on a dedicated page of the EDQM website.
Source: https://www.edqm.eu/en/web/edqm/ph-eur-technical-guides
FDA published guideline on its website “Assessing User Fees Under the Generic Drug User Fee Amendments of 2022”
Date: June 09, 2023
This guidance provides information to stakeholders regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2022 (GDUFA III) under Title III of the FDA User Fee Reauthorization Act of 2022. Because GDUFA III created changes to the user fee structure, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
This guidance describes the types of user fees authorized by GDUFA III, and the processes for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations. This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees. FDA will issue separate guidance documents regarding GDUFA III non-user fee requirements and processes. This guidance does not address how FDA determines and adjusts fees for each fiscal year, nor does it address FDA’s implementation of other user fee programs (e.g., under the Prescription Drug User Fee Act (PDUFA) or Biosimilar User Fee Act (BsUFA)). Throughout this guidance, references to user fees or the user fee program indicate generic drug user fees assessed and collected under section 744B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Source: https://www.fda.gov/media/132138/download
News from EDQM “Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation”
Date: June 19, 2023
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’.
The draft document for public consultation is now available in the consultation space. The consultation deadline for this document is 15 September 2023. After the consultation phase the final policy document will be made available on the EDQM website.
Source: https://www.edqm.eu/en/consultation-space
EMA publishes review of its studies on “Use of real-world evidence in regulatory decision making”
Date: June 23, 2023
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner.
News from EDQM “European Pharmacopoeia Supplement 11.3 now available”
Date: July 01, 2023
The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 is now available and will be applicable in 39 European countries as of 1 January 2024.
This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions are already available to purchase via the EDQM Store.
Source: https://www.edqm.eu/en/-/025-news-pheur-supplement-11.3
News from EDQM “Pharmeuropa 35.3 just released”
Date: July 03, 2023
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 35.3 is 30 September 2023.
Users and interested parties are welcome to comment on these drafts. It should be noted that:
Although draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states; if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.
It is therefore extremely important that users provide feedback on such drafts.
Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.
Source: https://www.edqm.eu/en/-/pharmeuropa-35.3-just-released
News from PIC/S “Publication of revised PIC/S GMP Guide (PE 009-17)”
Date: July 2023
PIC/S has published the revised PIC/S GMP Guide (PE 009-17), which includes the revised Annex 1 (for the background to the revision. PE 009-17 will enter into force on 25 August 2023. In the meantime, the current version of the PIC/S GMP Guide (PE 009-16) remains in force. Both versions of the PIC/S GMP Guide are published on https://picscheme.org/en/publications.
Source: https://picscheme.org/docview/6605
https://picscheme.org/docview/6606
https://picscheme.org/docview/6607
https://picscheme.org/docview/6608
EMA Begins to Phase Out COVID-19 Regulatory Flexibilities
Date: July 06, 2023
The European Medicines Agency (EMA) has started to phase out the regulatory flexibilities introduced during the COVID-19 pandemic. These flexibilities, which included aspects such as marketing authorization, manufacturing, imports, quality variations, labeling, packaging and compliance, were implemented to mitigate the pandemic’s impact on the pharma industry. With the World Health Organization declaring an end to the COVID-19 public health emergency, EMA has begun to gradually phase out these measures. However, certain allowances, such as English-only labeling of COVID-19 vaccines and extended validity of good manufacturing and distribution practice certificates, will continue until the end of the year to minimize disruption.
Source: https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has issued a guideline to regulate nitrosamine impurities in pharmaceutical products.
Date: July 07, 2023
This guideline allows product registration holders to submit their compliance documents, originally created for European and US requirements, to meet NPRA’s standards.
The guideline is applicable to all chemically synthesized active pharmaceutical ingredients (APIs) in pharmaceutical products intended for human use. However, it excludes non-scheduled poison, natural, and health supplement products. The guideline’s scope may be extended to include any products found to have nitrosamine impurity issues.
In formulating this guideline, NPRA has taken into account the guidance provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
FDA’s Digital Transition for Medical Device Export Documents
Date: July 10, 2023
From 2nd January 2024, the US Food and Drug Administration (FDA) will digitize key export documents for medical devices to enhance efficiency and reduce environmental impact. The documents will be available as downloadable PDFs from the Center for Devices and Radiological Health’s (CDRH) Export Certification Application and Tracking System (CECATS). They can be validated via the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Paper certificates will only be issued for requests received by 15th December 2023, and those reviewed before 2nd January 2024. Post this date, all requests will be processed electronically.
EMA’s Lifecycle Approach to AI/ML Drug Development
Date: July 13, 2023
The European Medicines Agency (EMA) has published a draft reflection paper detailing its approach to the use of artificial intelligence/machine learning (AI/ML) in drug development. The paper, developed by EMA’s Big Data Steering Group and the Heads of Medicines Agencies, outlines the use of AI/ML throughout the lifecycle of drugs, including during product development, authorization, and post-authorization.
The paper emphasizes that AI/ML tools can potentially support the acquisition, transformation, analysis, and interpretation of data across the medical product’s lifecycle. For instance, AI/ML modelling could be used to replace animal models during preclinical development. In clinical trials, AI/ML systems could support patient selection based on disease characteristics or other clinical parameters.
At the marketing-authorization stage, AI applications could be used to draft, compile, translate, or review data to be included in the product information of a medicine. In the post-authorization phase, such tools can support pharmacovigilance activities including adverse event report management and signal detection.
However, the use of AI/ML also brings challenges such as understanding the algorithms, their design and possible biases, as well as the risks of technical failures and their wider impact on AI uptake in medicine development and health.
FDA Drafts Guidance on Determining Non-Compliance with Postmarketing Requirements
The US Food and Drug Administration (FDA) has issued a draft guidance outlining how it determines if an applicant has shown good cause for failing to meet postmarketing requirements (PMRs) for human prescription drugs. The guidance applies to prescription drugs under section 505 and does not include non-prescription drugs, pediatric studies, accelerated approval trials, or trials required based on evidence from animal studies. Instances of non-compliance include missed milestones for final protocol, study completion, or final report submission. The FDA encourages proactive communication from applicants about progress and potential delays. Enforcement actions for non-compliance can include warning letters, misbranding charges, and civil monetary penalties.
Source: https://www.fda.gov/media/170187/download
Singapore’s HSA Drafts Legislation on Active Pharmaceutical Ingredient Regulation
Date: Jul 17, 2023
Singapore’s Health Sciences Authority (HSA) has released draft legislation for regulating active pharmaceutical ingredients (APIs), aiming to establish a risk-based licensing framework in line with international standards. The proposed law will apply to APIs used in the manufacture of therapeutics, cell tissue or gene therapies, and medical devices. The HSA plans to implement inspection and licensing controls for all manufacturers, importers, and wholesalers of APIs used in health products for local clinical use. The authority is seeking feedback on these proposals until 17th August. Concurrently, HSA is also seeking feedback on the lead times companies will need to prepare for full implementation of the submission requirement for evidence of Good Manufacturing Practice (GMP) compliance for chemical drug substance manufacturers.
WHO Proposes Best Practices for Clinical Trials
Date: July 19, 2023
The World Health Organization (WHO) has issued a draft guidance outlining scientific and ethical considerations for well-designed clinical trials. The guidance aims to strengthen the clinical trial ecosystem and improve the enrollment of under-represented populations.
The document emphasizes that good clinical trials should be designed to produce scientifically sound answers to relevant questions, respect the rights and well-being of participants, and have processes proportionate to their context and associated risks. It also addresses the issue of over interpretation of existing regulations and guidance for clinical trials, which has led to excessive bureaucracy and unnecessarily onerous procedures.
The guidance suggests efforts need to be made to recruit diverse populations into clinical trials. The research community is encouraged to engage with patients, the public, and communities to include as broad and varied a population as possible.
The document complements existing ethical and scientific standards in conducting clinical trials with a focus on under-represented populations. It does not supersede any existing guidance.
WHO’s Proposed Alignment with Global Bioequivalence Classifications with ICH
Month: July 2023
The World Health Organization (WHO) is proposing to align its bioequivalence classifications with global guidelines, reducing the need for in vivo studies to prove bioequivalence with a reference product. The draft document, Biopharmaceutics Classification System-Based Biowaivers, would align WHO’s policies with those adopted by the International Council for Harmonisation’s 2019 M9 Biopharmaceutical Classification System-Based Biowaivers guideline.
The proposal allows an active pharmaceutical ingredient (API) to be considered bioequivalent if it exhibits the same properties of aqueous solubility and intestinal permeability in lab studies. WHO categorizes APIs into four classes, with biowaivers only available for Class I and Class III APIs.
The document details how to assess solubility and permeability of APIs. An API is considered highly soluble if the highest single therapeutic dose is completely soluble in 250 mL or less of aqueous media over the pH range of 1.2–6.8 at near body temperature. An API is considered highly permeable if the absolute bioavailability is at least 85%, or if 85% of the administered dose can be recovered in urine as parent drug.
A Finished Pharmaceutical Product (FPP) might also be eligible for a biowaiver if all of its APIs satisfy the solubility and permeability requirements of being Class I or III agents; if the FPP is an immediate-release oral medication; and if it is the same dosage form and strength as the reference product. BCS-based biowaivers can only be applied to immediate-release, solid, oral forms or suspensions that deliver the API directly to systemic circulation.
Excipients in a formula can affect a product’s potential qualification for a BCS-based biowaiver. They can impact solubility, gastrointestinal motility, transit time, intestinal permeability and systemic absorption. To qualify for a BCS-biowaiver, the total amount of excipient has to be within a 10% range of the reference product’s excipient.
The European Medicines Agency (EMA) has provided further guidance on remote batch certification and residency requirements for qualified persons.
Month: July 2023
In their updated Q&A, the EMA clarified that remote batch certification might be permissible, provided it is allowed by the national regulator of the location where the authorized site is based. Manufacturers are advised to comply with local regulations. The EMA also highlighted several considerations for manufacturers, including the provision of necessary equipment at facilities to facilitate remote certification, and discussed the technical prerequisites.
Furthermore, the EMA clarified that there are no EU-wide rules regarding the residency of qualified persons. However, they noted that local regulations may apply in certain member states.
FDA Recognizes New Medical Device Sterilization Standards
Date: Jul 24, 2023
The Food and Drug Administration (FDA) has recognized a new international consensus standard, ISO 22441:2022, on the use of low temperature vaporized hydrogen peroxide for sterilizing medical devices. This comes amid efforts by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), a commonly used sterilant.
The standard offers an alternative sterilization method to device makers. The FDA also recognized two standards from AAMI related to technical information reports on medical device sterilization, aimed at advancing sterilization methods and assisting manufacturers in making changes to radiation sterilization processes.
The FDA’s recognition of these standards means they are deemed acceptable, and manufacturers can declare conformity to these standards to meet premarket submission or other requirements. This move supports supply chain resiliency.
However, concerns have been raised about the potential impact of restrictions on EtO sterilization on medical device supply constraints and shortages. In response, the FDA has been working on developing alternatives to EtO for medical device sterilization and launched a voluntary Radiation Sterilization Master File Pilot Program.
Australia’s TGA Proposes New Medical Device Application Audit Framework
Date: Jul 24, 2023
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on a proposed framework for auditing medical device applications. The proposal comes in response to changing EU regulations, industry concerns, and other factors.
The TGA assesses all applications against regulatory requirements, but some submissions are selected for a more thorough assessment known as an audit. The TGA has operated under interim processes for reviewing European Union Medical Device and In Vitro Diagnostic Regulation (MDR/IVDR) applications since July 2021.
The proposed new application audit framework is designed to be more responsive and risk-based. The TGA will select applications for audit based on postmarket signals, regulatory reforms, and regulatory intelligence. The aim is to provide more predictability and transparency regarding the types of applications likely to be selected for audit.
The TGA is also proposing to explore pathways for Class III devices supported by the Medical Device Single Audit Program (MDSAP) and US Food and Drug Administration (FDA) 510(k) clearance. Feedback is being sought on whether it would be worthwhile establishing a pathway for Class III medical devices based on MDSAP certification and US FDA 510(k) approval.
The TGA is accepting feedback on the draft until 4 September.
The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and two supplemental documents titled “M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes” and “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers”.
Date: Jul 25, 2023
These documents were prepared under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). They aim to harmonize the considerations for assessment and control of DNA reactive (mutagenic) impurities. This is an important step in ensuring the safety and efficacy of pharmaceuticals. The guidance and supplemental documents provide valuable information for industry professionals involved in the development and manufacturing of pharmaceuticals. They offer a comprehensive approach to limit potential carcinogenic risk from DNA reactive (mutagenic) impurities.
Source: https://www.fda.gov/media/170459/download
FDA Finalizes Guidance on Drug Quality Consensus Standards Recognition Program
Date : Jul 26, 2023
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published a final guidance on its process for recognizing voluntary consensus standards (VCS) related to pharmaceutical quality. The aim is to promote innovation in pharmaceutical development and manufacturing, and streamline the preparation and assessment of marketing applications.
The program applies to a range of CDER-regulated products, including brand drugs, generics, biologics, biosimilars, and over-the-counter medicines. The guidance describes CDER’s plans to publish a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality and outlines CDER’s policies and procedures for recognizing such standards.
The use of a recognized standard remains strictly voluntary. The program does not apply to regulatory requirements, such as certain provisions of the Federal Food, Drug, and Cosmetic Act relating to the United States Pharmacopeia. The program does not include electronic data exchange standards.
The final guidance includes a new section on requesting recognition in submissions and communicating with requestors. It also details how staff and stakeholders can submit a recognition request electronically through the CDER Direct nextGen Collaboration portal. Additionally, it includes a new section on how CDER’s Pharmaceutical Quality Standards Working Group will update CDER’s standards database.
Source: https://www.fda.gov/media/121305/download
FDA Completes First Joint Assessment with EMA in ICMRA Pilot
Date: Jul 28, 2023
The US Food and Drug Administration (FDA) has announced the completion of its first collaborative assessment of a post-approval change for an oncology medicine with the European Medicines Agency (EMA). This was conducted under the International Coalition of Medicines Regulatory Authorities’ (ICMRA) joint review pilot program.
The joint assessment teams had a positive and productive experience, producing a common set of highly aligned information requests and comments to the applicant. The assessment resulted in an FDA approval without any delay in the standard assessment timeline. In fact, it was completed under the four-month goal window for a standard manufacturing supplement assessment.
The EU approved the submission on the same day as the FDA. The joint assessment received positive feedback from industry. The ICMRA has accepted several proposals for the postapproval assessment pilot, including this recently completed FDA/EMA supplement assessment.
The ICMRA is also running a hybrid inspection pilot, which has accepted two proposals. For both proposals, regulators will conduct a collaborative facility assessment using a combination of on-site inspection and remote assessment tools. These pilots are due to be completed by early 2024.
Pharma GMP News of the Week: 25-April-2023
Period: April 23, 2023 to May 20, 2023
Guidance from South Africa “Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH”
Date of news: Apr 24, 2023
This guideline is meant to offer suggestions to applicants who seek to submit both new and modified registration applications. It reflects the Authority’s current views on the security, effectiveness, and calibre of pharmaceuticals. It’s not meant to be a one-stop shop. In order to determine the safety, effectiveness, and quality of a medicine in accordance with the knowledge available at the time of review, SAHPRA maintains the right to seek any additional information. Alternative methods may be employed, but they must be supported scientifically and technically. The Authority is committed to ensuring that all registered medicines meet the necessary standards for quality, safety, and efficacy. To prevent delays in the processing and examination of applications, it is crucial that applicants follow the administrative procedures.
Source: quality and bioequivalence guideline | sahpra
MHRA updated guidance “Registration & Regulating Medical Devices in UK”
Date of news: Apr 27, 2023
The main reason for the change to this guidance was to reflect the intention to continue accepting CE-marked medical devices on the British market after 30 June 2023. This advice has been revised to reflect changes to the Reference Guides for “Labelling requirements,” “Regulation of medical devices in Northern Ireland,” “Summary of key requirements for placing a device on the Great Britain market,” “Registrations in Great Britain,” “UKCA marking,” “CE marking and Notified Bodies,” and “Lapping requirements.”
Source: Regulating medical devices in the UK – GOV.UK
EMA Guidance “Pre & Post Authorisation for Users of the Centralised Procedure”
Date of news: Apr 28, 2023
The European Medicines Agency has updated and published the guidelines on “Pre-authorization procedural advice for users of the centralised procedure” and “Post-authorization procedural advice for users of the centralised procedure” this week (25 April 20223).
Advice on the pre-authorization process for those using the centralised procedure
The purpose of the pre-authorization procedural advice is to help applicants prepare and submit marketing authorisation applications under the centralised system.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA and the European Commission will use the information in this guidance to evaluate the quality, safety, and efficacy of pharmaceuticals.
Source: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
News from EDQM “Requirements for the content of the CEP dossier according to the CEP 2.0 and updated application forms”
Date of news: April 28, 2023
beginning part of the CEP 2.0 deployment, some modifications to the content of CEP applications will be made, AND beginning of June 1, 2023, the usage of revised application forms will be required:
FDA published guidance “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products”
Date of news: May 01, 2023
The Food and Drug Administration (FDA or Agency) has just released a final industry guideline titled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.” The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) oversaw the development of the guidelines. For the conduct and general layout of nonclinical biodistribution (BD) studies for gene therapy (GT) products, the final guidance offers standardised suggestions. According to the 3Rs (reduce/refine/replace) principles, the guidelines in the guidance aim to make it easier to create experimental GT products while reducing needless animal exploitation. A draught of the guideline titled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products” that was released on September 9, 2021 has been replaced by the final guidance.
Source: https://www.fda.gov/media/167605/download
FDA published guidance “Study Data Technical Conformance Guide – Technical Specifications Document”
Date of news: May 01, 2023
The Food and Drug Administration (FDA)’s (FDA) current thinking on this subject is reflected in this set of technical requirements. It has no effect on the FDA or the general public and neither does it grant anyone any new rights. If an alternative strategy complies with the requirements of the relevant statutes and regulations, you may employ it. If you want to talk about a different strategy, get in touch with the FDA team that is responsible for putting this advice into action. Send an email to cder-edata@fda.hhs.gov or cber.cdisc@fda.hhs.gov if you are unable to locate the relevant FDA staff.
Source: https://www.fda.gov/media/153632/download
FDA published guidance “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products”
Date of news: May 01, 2023
The Food and Drug Administration (FDA or Agency) has released a final industry guideline document titled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.” The paper offers recommendations to help sponsors with the clinical development of nicotine replacement therapy (NRT) pharmacological products, including but not limited to those intended for chronic indications related to smoking cessation and others. This guideline completes the draught of the same-titled guidance that was released on February 22, 2019.
Source: https://www.fda.gov/media/167599/download
FDA published guidance “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022”
Date of news: May 01, 2023
The FDA User Fee Reauthorization Act of 2022’s Title I offers information to stakeholders about the EFDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII). This guidance explains the changes made by the statute, which include changes to specific definitions, changes to specific PDUFA fee exceptions, waivers, exemptions, reductions, and returns2, as well as certain changes for PDUFA invoicing procedures, because PDUFA VII resulted in changes to the user fee programme.
Source: https://www.fda.gov/media/167877/download
MHRA Published three blog post on its website
Date of news: May 02, 2023
- MHRA Good Distribution Practice Symposium 2023
- MHRA Good Manufacturing Practice Symposium 2023
- ICH E6(R3) Good Clinical Practice guidance – Step 2 Public Consultation
Source: MHRA Inspectorate
FDA published guideline “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”
Date of news: May 02, 2023
The decentralised clinical trials (DCTs) for pharmaceuticals, biological products, and devices should be implemented according to the guidelines provided in this draught guidance for sponsors, investigators, and other stakeholders. In this advice, a clinical trial is referred to as a DCT if some or all of the trial-related activities take place elsewhere other than the typical clinical trial venues.
Clinical trials that are completely decentralised conduct all of their operations apart from the usual trial venues. These trial-related events may occur at trial participants’ residences or in close-by medical centres that are convenient for trial participants. In hybrid DCTs, certain trial activities include trial participants visiting typical clinical trial sites in person, while other activities are carried out elsewhere, such at participants’ homes.
Source: https://www.fda.gov/media/167696/download
EMA published Interim Guidance “How to Approach the “PPD and CCI” while using CTIS”
Date of news: May 03, 2023
The goal of this guidance document is to help CTIS users use CTIS functionalities and understand the key guidelines for protecting personal information and business secrets when using CTIS and disseminating clinical trial information and materials.
The European Union’s Clinical Trials Information System (CTIS) is an IT platform that incorporates the EU portal and EU database that enables the interchange of clinical trials data within the EU.
Any information pertaining to an identified or recognisable natural person (the “data subject”) is referred to as personal data (PD).
Information submitted to CTIS that is not in the public domain or publicly accessible and whose publication could jeopardise the party’s legitimate economic interest or competitive position is referred to as commercially confidential information (CCI).
FDA published guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”
Date of news: May 03, 2023
The decentralised clinical trials (DCTs) for pharmaceuticals, biological products, and devices should be implemented according to the guidelines provided in this draught guidance for sponsors, investigators, and other stakeholders. In this advice, a clinical trial is referred to as a DCT if some or all of the trial-related activities take place elsewhere other than the typical clinical trial venues. Clinical trials that are completely decentralised conduct all of their operations apart from the usual trial venues. These trial-related events may occur at trial participants’ residences or in close-by medical centres that are convenient for trial participants. In hybrid DCTs, certain trial activities include trial participants visiting typical clinical trial sites in person, while other activities are carried out elsewhere, such at participants’ homes.
Source: https://www.fda.gov/media/167696/download
FDA published guidance “Q9(R1) Quality Risk Management” on its website
Date of news: May 03, 2023
The Food and Drug Administration (FDA or Agency) has just released a final industry advice document titled “Q9(R1) Quality Risk Management.” The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) oversaw the development of the guidelines. The guidelines, which are a targeted revision of the industry’s “Q9 Quality Risk Management” guidance from 2006, address risks to product availability resulting from poor manufacturing quality, a lack of understanding of what formality in Quality Risk Management (QRM) work entails, a lack of clarity regarding risk-based decision-making, and a high degree of subjectivity in risk assessments and QRM outputs. The revision aims to offer guidance on quality risk management practises and instruments that can be utilised in various pharmaceutical quality.
Source: https://www.fda.gov/media/167721/download
Guidance from Swiss Medic “Transfer of Marketing Authorisation”
Date of news: May 03, 2023
The guidelines in this document outline the prerequisites and requirements (together with the required supporting documentation) for submitting an application to transfer authorizations for human and animal medical products.
Swissmedic released the guideline document to make clear the specifications that must be fulfilled in accordance with its practise.
This guideline paper is applicable to requests in the Infrastructure, Authorization, and Market Surveillance divisions for the transfer of marketing authorizations to new marketing authorization holders.
In addition, the advice document offers details on the application deadline, the transfer fees, the repercussions of the transfer, and the supporting documentation needed to complete the application. The advice document also explains the duties of the new owner, including assuring the efficacy, safety, and quality of the product.
Source: Guidance document – Transfer of marketing authorisation
News from EDQM “Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components”
Date of news: May 05, 2023
The European Pharmacopoeia Commission (EPC) decided to develop three new general texts addressing issues linked to the development and control of mRNA vaccines and their components as a way to help this developing sector at its 175th session in March 2023.
Guidance from South Africa’s SAPHRA “Validation Template For ECTD Variation Applications, QOA & QIS”
Date of news: May 05, 2023
How to validate electronic submissions of variation applications for human pharmaceuticals in South Africa is explained in SAPHRA’s Validation Template For ECTD Variation Applications.
When assessing a modification application submitted in eCTD format for a medicinal product for human use, SAHPRA can confirm that all necessary information has been given by using the application’s validation template. The validation criteria, the validation procedure, the validation report, and the validation checklist are all included in this section.
The applicant must make sure that all pertinent areas are filled out because it is also utilised for follow-up sequences that may be necessary for the variant.
The deadline for implementation is May 15, 2023.
Source: VALIDATION TEMPLATE FOR eCTD VARIATION APPLICATIONS
Guidance from Ireland’s HPRA “Guidance on Reporting & Investigation of Quality Defects”
Date of news: May 2023
One of the main goals of this guidance is to offer stakeholders with extra guidance beyond that found in the legislation so that stakeholders
(i) To reduce the danger to people or animals, properly report and investigate any suspected quality flaws within the necessary timeframes.
Apply the necessary monitoring to defect concerns in accordance with the degree of risk posed (ii).
(iii) Conduct thorough root cause analysis (RCA) investigations to make sure the proper corrective and preventive measures are put in place, to stop the issues that caused the quality fault from happening again.
This manual outlines the procedures for examining and informing the HPRA of quality issues with human and veterinary pharmaceuticals.
Guideline from EC MDCG “Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR”
Date of news: May 2023
This guidance document aims to define “significant changes in the design and intended purpose” as defined by MDR Article 120(3c), Point (b).
In the European Union (EU), the term “legacy device” refers to a medical device that was lawfully marketed before the Medical Devices Regulation (MDR) took effect.
There must be a change in the design or intended purpose in addition to the change being significant for there to be a significant change in the design or intended purpose.
It is the manufacturer’s duty to demonstrate and justify changes so that they do not affect the device’s intended function or design, or, if they do, that they are minor and should be evaluated individually.
Source: https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf
FDA published guidance “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol”
Date of news: May 08, 2023
The purpose of this recommendation is to warn glycerin and other high-risk medication components contaminated with diethylene glycol (DEG) or ethylene glycol (EG) about the potential public health danger they pose. The FDA has received and is still receiving reports (most recently in early 2023) of fatal poisonings of users of liquid dosage drug products (such as cough, allergy, analgesic, and antiemetic medicine products) that were produced with DEG- or EG-contaminated components.
Source: https://www.fda.gov/media/167974/download
FDA published guidance “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”
Date of news: May 11, 2023
In order to offer suggestions for determining donor eligibility using specific risk-based questions, the FDA is providing this guidance. The FDA’s updated donor deferral recommendations for those with a higher risk of transmitting human immunodeficiency virus (HIV) infection are provided to you, blood establishments that collect blood or blood components, including Source Plasma. We also advise that you update your donor requalification and product management procedures in accordance with the changes you make to your donor education materials, donor history questionnaires, and supporting materials.
Source: https://www.fda.gov/media/164829/download
FDA published guidance “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components”
Date of news: May 11, 2023
The standardised full-length and condensed donor history questionnaires and related materials, version 4.0 dated May 2023, created by the AABB Donor History Task Force, are recognised as suitable in this guidance. In accordance with Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12), this guideline also offers recommendations to licenced establishments on how to report implementation of the appropriate AABB donor history questionnaires and related materials (DHQ papers).
Source: https://www.fda.gov/media/124193/download
Guideline from UK MHRA “Guidance on Qualified Person responsible for QPPV & PSMF”
Date of news: May 11, 2023
The previous section, “Notification of QPPV and PSMF details to the MHRA by existing holders of UK marketing authorisations,” has been changed with new instructions. The former requirement to submit a Type IA(IN) variation and an associated eCTD sequence to make these changes has been replaced by this guidance. There is no longer a need to submit an eCTD sequence; instead, simply an update notification is needed.
Guideline from UK MHRA “Notifying MHRA on a Clinical Investigation for a Medical Device”
Date of news: May 11, 2023
The maker or sponsor may be required to carry out a clinical investigation in order for your medical device to receive a UKCA / CE / CE UKNI label. You must also give the MHRA sixty days’ notice if you intend to conduct an investigation.
Medical equipment that are UKCA, CE, or CE UKNI marked for the use that is being investigated won’t need to be notified to the MHRA.
The regulatory staff at MHRA will evaluate the application against the Validation Checklist- GB New Submissions when it is received for a clinical research of a medical device. This checklist will assist in submitting a legitimate application.
Source: Notify the MHRA about a clinical investigation for a medical device – GOV.UK
Guideline from EMA “Good Practices for Industry for the Prevention of Human Medicinal Product Shortages”
Date of news: May 17, 2023
The European Medicines Regulatory Network (EMRN) and other international agencies acknowledge that there is an international issue with pharmaceutical shortages. European nations have experienced an increase in shortages throughout time, which has had a significant influence on patient treatment.
In accordance with this document, marketing authorization holders, distributors, wholesalers, and manufacturers are urged to implement best practises for preventing shortages in human medication, such as lowering the likelihood that shortages may emerge in the first place. Also offered are suggestions for minimising a scarcity occurrence.
To guarantee the continuity of drug supply, this guidance includes topics including supply chain management, risk assessment, communication, and contingency planning. The advice aims to encourage industry cooperation and proactive actions to reduce the effects of shortages and assure the availability of necessary medicines for patients.
Source: Good practices for industry for the prevention of human medicinal product shortages
Guideline from MHRA ‘Med Dev Guidance on “Off-Label Use”,”Virtual Mfg.” “Legal Requirements” & “Approved Bodies”’
Date of news: May 16, 17, 2023
This week (16–17 May 2023) the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) amended a number of guidances pertaining to medical devices.
Source:
- Guidance on “Medical Devices: Software Applications (apps)“
- Guidance on “Virtual manufacturing of medical devices“
- Guidance on “Medical devices: Legal Requirements for Specific Medical Products“
- Guidance on “Medical devices: Off-Label Use“
- Guidance on “Approved Bodies for Medical Devices“
Guidance on “Medical Devices: Software Applications (apps)”
Guidance from USFDA “Pediatric Drug Development – Regulatory and Scientific Considerations”
Date of news: May 18, 2023
On 18-May-2023, the US Food & Drug Administration published two draft guidelines, “Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” and “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations“.
Source:
1. Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for P
Pharma GMP News of the Week: 25-April-2023
Period: April 9, 2023 to April 22, 2023
FDA has published “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers”
Date of news: April 12, 2023
This guidance offers details on risk-based methods for observing how clinical trials for human drugs, biologicals, medical devices, and combination products are carried out. A quality control approach for assessing whether investigational activities are being carried out according to plan is clinical investigation monitoring. This advice includes suggestions for organising a monitoring strategy, creating a monitoring plan’s content, and dealing with and sharing monitoring outcomes. By adding further details to help sponsors execute risk-based monitoring, this guideline builds on the industry’s Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) approach.
Source: A Risk-Based Approach to Monitoring of Clinical Investigations–Questions and Answers
FDA has published Draft Guidance for Industry on “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs”
Date of news: April 12, 2023
“Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs” (Revision 2) is the name of a revised draft guidance for industry that the Food and Drug Administration (FDA or Agency) is stating is now available. The same-named draught guidance (Revision 1), which was published in the Federal Register on October 10, 2018, is revised by this draught guidance (Revision 2). This updated draft of the guidance offers suggestions for the planning and execution of studies assessing the effectiveness of transdermal or topical delivery systems (collectively referred to as TDSs) for adhesion. Applicants may decide to analyse TDS adhesion in studies carried out only to do so or in studies carried out with a mixed purpose depending on the goals of a generic TDS product development programme.
Source: https://www.fda.gov/media/167043/download
FDA has published “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs”
Date of news: April 13, 2023
The Food and Drug Administration (FDA or Agency) has made an updated draught guideline document for industry available titled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” This updated draught guidance offers suggestions for the planning and execution of studies to assess a proposed transdermal or topical delivery system’s (collectively referred to as TDS) potential for in vivo skin irritation and sensitization (I/S). The recommendations in this updated draught advice pertain to studies that are submitted in support of an ANDA. In vivo skin I/S studies are covered in the FDA’s guidelines and expectations, which are clarified in the revised drafting guidance. The October 2018 draught guidance titled “Assessing the Irritation and Sensitization Potential” has been updated by this guidance.
Source: https://www.fda.gov/media/167073/download
FDA has published “Over-the-Counter Monograph Order Requests: Format and Content”
Date of news: April 13, 2023
The goal of this advice is to help requestors create OTC monograph order requests (OMORs) that can be submitted to the FDA in accordance with section 505G of the FD&C Act (21 U.S.C. 355h). This guidance lists pertinent guidance materials to help requestors prepare their OMORs and offers FDA’s recommendations on the structure and information that requestors should include in them.
Source: https://www.fda.gov/media/167035/download
FDA has published “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment”
Date of news: April 19, 2023
The Food and Drug Administration (FDA or Agency) is announcing the release of a new industry advice document titled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” This draught guidance is meant to help sponsors and other interested parties develop medications to prevent or treat acute radiation sickness (ARS), which is brought on by exposure to ionising radiation from unintentional or intentional sources. Drugs created for these uses typically need to receive approval under the laws known as the “Animal Rule.”
Source: https://www.fda.gov/media/167172/download
EMA seeks public consultation on a reflection paper “Single-arm trials as pivotal evidence for the authorisation of medicines in the EU”
Date of news: April 21, 2023
The European pharmaceuticals Agency (EMA) has initiated a public consultation on a reflection paper with a PDF icon that addresses key ideas for single-arm clinical trials that are provided as crucial support for marketing authorization requests for pharmaceuticals in the European Union (EU). This is the first advice document from a global medical regulator outlining the factors and difficulties involved in conducting clinical studies of this nature. By midnight (CET) on September 30, 2023, stakeholders are requested to submit their opinions via an online form.
Source: Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
Health Canada has published “Guidance on Nitrosamine Impurities in Medications”
Date of news: April 17, 2023
Health Canada gives its current opinions and suggestions in this guideline on N-nitrosamine impurities (also known as nitrosamine impurities or nitrosamines), but it reserves the right to change it when new information becomes available or as more applicants or market authorization holders (MAHs) need clarification.
Some medications and other items that include the nitroso functional group (-NO), which is recognised as a possible carcinogen, may have nitrosamine impurities, a form of chemical impurity.
Manufacturers must conduct risk analyses and implement the necessary controls to limit the possibility of nitrosamine generation, including employing diverse manufacturing procedures, acquiring materials from other vendors, and carrying out further testing.
Source: Guidance on nitrosamine impurities in medications | Health Canada
EMA has published Guidance “IRIS guide to Registration and Research Product Identifiers”
Date of news: April 20, 2023
The “IRIS guide to Registration and RPIs” was updated and made available by the European Medicines Agency last week (20 April 2023); it goes into great detail about the preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
The database known as IRIS—which stands for “Integrated Review and Information System”—is used by the European Medicines Agency (EMA) to oversee the evaluation of requests for marketing authorization of pharmaceuticals in the European Union.
During the evaluation process, the IRIS system offers a platform for communication and information sharing between the EMA and national regulatory bodies. The system is a safe, web-based tool for managing regulatory submissions, analysing data, and producing reports.
Source: IRIS guide to registration and RPIs v2.13
Malaysia NPRA published Guideline on “Electronic Labelling (E-LABELLING) for Pharmaceutical Products”
Date of news: April 11, 2023
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated version of its “Electronic Labelling (E-Labelling) for Pharmaceutical Products” guideline. This guideline is essential for ensuring that patients understand their treatments and for assisting HCPs in their decision-making.
The product information consists of labels, a package information booklet, and a summary of the product’s features, all of which are based on clinical development and post-marketing data. Both people and healthcare professionals (HCPs) are the target audience for these descriptions.
This paper serves as a roadmap for the adoption of voluntary e-labelling, and the Drug Control Authority must authorise the product information utilised.
Source: GUIDELINE ON ELECTRONIC LABELLING (E-LABELLING) FOR PHARMACEUTICAL PRODUCTS IN MALAYSIA April 2023
IMDRF published Guidance on CyberSecurity, Post-Market Surveillance, and Personalized Medical Devices
Month of news: April 2023
The IMDRF published four new technical guidelines, titled “Personalised Medical Devices – Production Verification and Validation,” “Principles and Practises for the Cybersecurity of Legacy Medical Devices,” “Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form,” and “Principles and Practises for Software Bill of Materials for Medical Device Cybersecurity.”
The International Medical Device Regulators Forum is a voluntary association of medical device authorities from different parts of the world who have gotten together to standardise the rules governing medical devices.
IMDRF encourages global cooperation and standardisation with the aim of enhancing the quality, safety, and efficacy of medical devices.
Source:
Personalized Medical Devices – Production Verification and Validation
Principles and Practices for the Cybersecurity of Legacy Medical Devices
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity
Pharma GMP News of the Week: 13-April-2023
Period: April 2, 2023 to April 8, 2023
Japan’s PMDA published guidance on “System for reporting side effects and defects during clinical trials”
Month of news: April 2023
It will be necessary to use the electronic application data system to submit reports of adverse medication reactions and flaws during clinical trials starting on April 1, 2023.
Only when it is difficult to send earlier reports of adverse reactions or malfunctions from clinical trials on paper, as well as the most recent clinical trial safety reports, are they accepted via email.
Clinical trial sponsors (pharmaceutical firms, etc.) and physicians or dentists (those who conduct clinical trials themselves) are required under the Pharmaceuticals and Medical Devices Acts to report adverse responses, issues, etc. Throughout clinical trials, the Ministry of Health, Labor, and Welfare must be updated.
Statutory guidance on MHRA fees: Fees for 2023 – 2024 have increased from 2022 – 2023
Date of news: April 1, 2023
To guarantee the MHRA covers its expenditures and maintains financial stability in the coming years, new fees are being implemented for a variety of services starting on Saturday, April 1, 2023.
The increased costs will make it possible for the MHRA to provide a quick and effective regulatory service that safeguards and enhances patient and public health by easing access to superior, risk-free, efficient, and cutting-edge medical products.
The adjustments aim to achieve cost recovery in accordance with HM Treasury’s policies on managing public money in order to guarantee that reasonable and proportionate rates are established for MHRA customers. The following significant changes take effect on April 1:
– A 10% increase in all statutory fees. This represents cost increases since the most recent comprehensive MHRA prices review in 2016.
– To achieve full cost recovery, 58 rates for services that are considerably undercovering costs will be increased.
– The implementation of 18 additional service tariffs that demand cost recovery
Source: https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees
Japan’s PMDA published “FAQs on Electronic Study Data Submission posted”
Date of news: April 3, 2023
The use of data-based quantitative information, including those derived from modeling and simulation (M&S) methodologies, has been aggressively encouraged in modern drug development.
In such cases, PMDA acknowledges the necessity of gathering electronic study data, processing it using cutting-edge techniques, and utilizing the results in the course of its evaluations and consultations. The utilization of such gathered data is anticipated to lessen the regulatory submission workload for sponsors, enhance PMDA’s evidence-based assessments and consultations, and result in the creation of new recommendations, all of which would eventually increase the success rate of drug development.
Source: New Drug Review with Electronic Data | Pharmaceuticals and Medical Devices Agency
FDA published guideline on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”
Date of news: April 03, 2023
In order to protect and advance public health, FDA is providing this draft guideline to further develop a regulatory strategy suited to artificial intelligence/machine learning (AI/ML)-enabled devices.
This will enhance patients’ access to reliable AI/ML-enabled devices. As stated in the FDA’s 2019 AI/ML Discussion Paper and 2021 AI/ML Action Plan, this draft advice outlines the least onerous method to facilitate the iterative improvement of machine learning-enabled device software functions (ML-DSF) while continuing to ensure their safety and effectiveness. A Predetermined Change Control Plan (PCCP) that may be included in a marketing proposal for ML-DSF should include the information recommended in the draft advice.
The anticipated ML-DSF adjustments, the associated methods to put those alterations into practice and validate them, and an assessment of the impact of those modifications.
News from EMA “New features further strengthen Priority Medicines scheme”
Date of news: April 4, 2023
To boost its assistance for the development of medicines in areas of unmet medical needs, EMA is adding a number of new features to the Priority Medicines (PRIME) scheme. The PRIME programme makes potentially life-saving medications more readily available to patients. 26 medications that benefited from PRIME funding had been recommended for approval in the European Union by the end of 2022. (EU).
A study of the program’s first five years of use, which revealed certain chances for the programme to be strengthened further, led to the deployment of the new features.
A roadmap and product development tracker will be built for each PRIME development in order to maximize the early scientific and regulatory support given to promising treatments. While the development’s progress is continuously tracked and important topics for future discussion can be recognised during the process, both technologies will make it easier for regulators and developers to communicate continuously.
Source: New features further strengthen Priority Medicines scheme (PRIME)
FDA published draft on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making”
Date of news: April 05, 2023
The fourth in a series of four patient-focused drug development (PFDD) methodological guidance documents, this guidance outlines how stakeholders (patients, carers, researchers, medical product developers, and others) can gather and submit patient experience data and other pertinent information from patients and carers to be used for medical product development and regulatory decision-making.
FDA published draft on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act”
Date of news: April 05, 2023
An industry draft guideline document titled “Notification of a Permanent Discontinuance or Suspension in Production Under Section 506C of the FD&C Act” is now available, according to the Food and Drug Administration (FDA). In order to help the Agency in its efforts to prevent or mitigate shortages, the draft guidance is intended to assist applicants and manufacturers in providing FDA timely, accurate notifications about changes in the production of specific finished drugs and biological products as well as specific active pharmaceutical ingredients (API). The proposed guidance also describes how FDA informs the public when a product is in short supply.
News from ICH – The ICH M7(R2) Guideline reaches Step 4 of the ICH Process
Date of news: April 6, 2023
On April 3, 2023, the ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the M7(R2) Addendum, “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes,” reached Step 4 of the ICH Process.
Additionally, ICH publishes the questions and answers that go along with its “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” document, which was adopted on May 24, 2022. These documents serve to further clarify, foster convergence, and enhance harmonisation of the factors to be taken into account when assessing and controlling DNA reactive (mutagenic) impurities, which are covered in ICH M7 (R2).
Source: https://www.ich.org/news/ich-m7r2-guideline-reaches-step-4-ich-process
https://database.ich.org/sites/default/files/M7_QAs_Step_2_InformationalSlides_2020_0709_0.pdf
MHRA published guidance -Software and Artificial Intelligence (AI) as a Medical Device
Date of news: April 6, 2023
Intelligence and software play a crucial role in health and social care. Many of these items are governed as medical devices or in vitro diagnostic medical devices in the UK (IVDs). Access to significant Software Group deliverables is made available in this advice, which may be helpful.
Source: Software and Artificial Intelligence (AI) as a Medical Device – GOV.UK
EDQM published “Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023”
Date of news: April 6, 2023
On March 21 and 22, 2023, the European Pharmacopoeia Commission (EPC) convened its 175th session. The European Pharmacopoeia (Ph. Eur.) Supplement 11.4 (October 2023) will publish the 84 documents that the EPC approved at this session, with an implementation date of 1 April 2024. These 84 texts contained one new general chapter and 12 new monographs.
EDQM seeks Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2
Date of news: April 6, 2023
The European Pharmacopoeia Commission (EPC) decided to create a new general chapter, Phage treatment active substances and medicinal products for human and veterinary use (5.31), and tasked the recently established Bacteriophages Working Group with the job at its 170th session (June 2021). (BACT WP).
Pharma GMP News of the Week: 3-April-2023
Period: March 26, 2023 to April 1, 2023
PMDA, Japan published document on “Precautions for Cleaning and Disinfection of Gastrointestinal Endoscopes”
Month of news: March 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has issued guidelines for cleaning and disinfecting gastrointestinal endoscopes in order to limit the risk of contamination and device damage.
Concerns regarding cross-contamination while reusing gastrointestinal endoscopes and other similar devices have grown in recent years, prompting regulatory agencies and professional organisations to establish best practises for cleaning the items between usage.
The PDMA precautions are based on cases of improper cleaning. The possibility of cleaning components lingering in the endoscope tube is described in two situations. During surgery, the brush fell into the patient’s body in one occasion. To reduce that risk, the PMDA is requesting that anyone who cleans endoscopes check to see if any of the brush has broken off.
Source: https://www.pmda.go.jp/files/000251414.pdf
MHRA updated guidance on “How to register your medical devices with MHRA
Date of news: March 27, 2023
Source: Register medical devices to place on the market – GOV.UK
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR)
Date of news: March 28, 2023
Source: Extension of CE certificates – GOV.UK
FDA published draft guideline “Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions”
Date of news: March 29, 2023
The FDA has issued a new draft guideline describing what information should be included in premarket submissions for orthopaedic non-spinal bone plates, screws, and washers.
The proposed guidance is designed to clarify information in class II orthopaedic non-spinal, non-resorbable medical device 510(k) submissions, such as bone plates, screw systems, freestanding bone screws, and washers for bone fixation. The proposed guidance’s purpose is to “encourage consistency in information supplied in submissions by addressing common inadequacies relating to device description and performance testing and identifying suitable cross-cutting guidances and consensus standards.”
Source: https://www.fda.gov/media/166507/download
FDA published guideline “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act”
Date of news: March 30, 2023
Because the Agency decided that prior public involvement is not practicable or appropriate, this guideline is being implemented without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2)). The FDA has determined that obtaining public feedback prior to the 90-day statutory limit for the implementation date of Section 524B of the FD&C Act is not possible. Although this policy is being adopted without previous notice, the FDA will review any comments received and amend the guidance paper as necessary.
Source: https://www.fda.gov/media/166614/download
FDA published guideline “Identification of Medicinal Products — Implementation and Use”
Date of news: March 30, 2023
This document provides assistance to sponsors, applicants, and registrants involved in the regulatory filing of medical product data. The advice helps to establish and apply the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information used throughout the worldwide medicinal product development lifecycle. The goal of these guidelines is to improve the quality, completeness, and consistency of information sent between stakeholders in the worldwide exchange of pharmaceutical products.
Source: https://www.fda.gov/media/166736/download
News from EMA “Regulatory information – adjusted fees for applications to EMA from April 1, 2023”
Date of news: April 1, 2023
News from MHRA “New statutory fees for MHRA services introduced from 1 April 2023”
Date of news: April 1, 2023
Source: New statutory fees for MHRA services introduced from 1 April 2023 – GOV.UK
FDA published draft guideline “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”
Date of news: April 3, 2023
In order to protect and promote public health, the FDA is providing this draught guideline to further develop a regulatory approach specific to artificial intelligence/machine learning (AI/ML)-enabled devices in order to increase patients’ access to safe and effective AI/ML-enabled devices. This draught guidance describes a minimally invasive strategy to supporting iterative development of machine learning-enabled device software functions (ML-DSF) while maintaining their safety and effectiveness, as stated in the FDA’s 2019 AI/ML Discussion Paper and 2021 AI/ML Action Plan. The draught guidance recommends information to include in a Predetermined Change Control Plan (PCCP) that may be included in a marketing submission for ML-DSF.
The PCCP mechanism includes the anticipated ML-DSF improvements, the process for implementing and validating such modifications, and an assessment of their impact. Since the PCCP concept was introduced, there has been a lot of interest in employing it for AI/ML-enabled medical devices. The FDA continues to receive an increasing number of marketing submissions and pre-submissions for AI/ML-enabled medical devices that have the potential to have a large beneficial impact on healthcare, and the Agency expects this to continue.
Source: https://www.fda.gov/media/166704/download
News from EU “Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices”
Month of news: April 2023
The European Commission has responded to inquiries regarding “practical aspects” of legislation to extend the transition period for the Medical Device Regulation (MDR). The Commission outlines the scope of the extension and how businesses might profit from the modifications in the question-and-answer document.
The Commission answers 18 issues in the 10-page text, including whether the revised transitory period applies to custom-made devices, how to demonstrate that a legacy device benefits from the extension, and more. The concerns range from general points, such as the fact that only older devices are eligible for the prolonged transition period, to precise terms used in the legislation.
Source: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf
Pharma GMP News of the Week: 26-March-2023
Period: March 19, 2023 to March 25, 2023
ICH Published Introductory Training Presentation on The ICH Q9(R1)
Date of news: March 20, 2023
In January 2023, the ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 of the ICH Process.
After the acceptance of this Guideline, the Q9(R1) Expert Working Group created a Step 4 Introductory Training Presentation.
Source: ICH Q9(R1): Quality Risk Management
The European Directorate for the Quality of Medicines and HealthCare (EDQM) is requesting feedback from CEP users in preparation for the launch of CEP 2.0
Date of news: March 20, 2023
In order to implement the CEP 2.0, the European Directorate for the Quality of Medicines & Healthcare (EDQM) is looking for feedback from users of the Certification of Suitability (CEP). One of the decisions made in this regard is to replace the declaration of access box on the CEP document with a letter of access.
Users may now check to see if the draught letter template satisfies their needs by visiting the consultation space where it is now accessible for public comment. The deadline for comments on this paper is April 16, 2023. The final template will be made accessible on the EDQM website following the consultation period.
As part of the CEP 2.0 implementation, it will be necessary as of 1 June 2023 to include the EMA SPOR/OMS ORG ID and LOC ID for all organisations engaged in Certification of Suitability (CEP) dossiers in the application forms for new dossiers, sister files, changes, and renewals.
Date of news: March 20, 2023
As part of the CEP 2.0 implementation, it will be obligatory as of 1 June 2023 to include the EMA SPOR/OMS ORG ID and LOC ID for all organisations engaged in Certification of appropriateness (CEP) dossiers in the application forms for new dossiers, sister files, changes, and renewals. Updated CEP application forms will be made available in the near future.
In addition to company names and addresses, CEPs will include the ORG ID and LOC ID (unique identifiers for an organisation and its locations). Applicants must supply the data during the dossier review process for ongoing applications for which a CEP is to be granted. As a result, businesses are recommended to get an ORG ID and LOC ID as soon as feasible.
Press release from MHRA “MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years”
Date of news: March 21, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) will implement a range of new initiatives, with the help of partners, to make it faster and easier to get authorisation and conduct clinical trials in the UK. These revisions mark the most significant revamp in UK clinical trials legislation in over 20 years, and will help to make the UK one of the greatest places in the world for patients and researchers to undertake clinical research.
MHRA Published Consultation outcome on proposals for legislative changes for clinical trials
Date of news: March 21, 2023
Working closely with the HRA, the MHRA and the Department of Health in Northern Ireland consulted on a series of recommendations to update, enhance, and reinforce UK law that supports clinical trial regulation. After reviewing over 2000 replies, we will now introduce legislation to modernise the UK clinical trials regulatory structure, which would:
a. Ensuring that patients and their safety remain at the forefront of all clinical studies, and that the benefits of clinical trials are available to everyone.
c. Provide a proportional and adaptable regulatory environment.
c. Establish the United Kingdom as a venue for international trials.
d. Offer a structure that is efficient, nimble, and adaptable to change.
Source: Consultation on proposals for legislative changes for clinical trials – GOV.UK
EMA published mid-point report on advancing regulatory science in the EU
Date of news: March 22, 2023
The European Medicines Agency (EMA) has issued a report summarising the mid-term achievements of its Regulation Science Strategy (RSS) until 2025. The report presents a summary of the key deliverables completed in the human and veterinary sectors between March 2020 and December 2022.
“The accomplishments highlighted in this report show that we have made significant progress in strengthening regulatory science to establish a more adaptable regulatory system that supports innovation in human and veterinary medicines,” said Emer Cooke, Executive Director of the European Medicines Agency.
Source: Advancing regulatory science in the EU – mid-point report published | European Medicines Agency
MHRA is Crafting text for an intended purpose in the context of Software as a Medical Device (SaMD)
Date of news: March 22, 2023
It is important to clearly define the intended purpose of a medical device in order to comply with medical device regulations. Failure to do so can make it more difficult to design a quality management system, generate sufficient clinical evidence, and implement a post-market surveillance system. The MHRA considers an inadequately defined intended purpose to be a serious failure to meet medical device requirements, which could lead to inadequate information for the safe and proper use of the device.
Properly defining the intended purpose of a medical device is essential for minimizing risks, meeting legal requirements, and demonstrating the benefits of the device. It also helps to articulate the value proposition of the device when conducting cost-effectiveness analyses for evaluation and procurement purposes. Clear definition of intended purpose is also beneficial when engaging with the wider health and social care sector.
This guidance document specifically addresses how to define the intended purpose for Software as a Medical Device (SaMD) and is intended to help SaMD manufacturers meet their legal obligations.
Source: Crafting an intended purpose in the context of software as a medical device (SaMD) – GOV.UK
Pharma GMP News of the Week: 19-March-2023
Period: March 12, 2023 to March 18, 2023
News from EMA “EMA finalises guidance on computerised systems and electronic data in clinical trials”
Date of news: March 9, 2023
The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. This document is intended to help stakeholders adapt to increases in the complexity of computerized systems. It highlights the rapid changes that have occurred as electronic case report forms, electronic patient reported outcomes, wearable devices and artificial intelligence have become part of the clinical trial landscape. EMA has designed the guidance to help stakeholders use the new technologies while ensuring the quality and reliability of trial data and the rights, dignity, safety and wellbeing of trial participants.
FDA published draft guideline “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”
Date of news: March 13, 2023
The use of electronic systems, electronic records, and electronic signatures in clinical studies of foods, medicines, tobacco products, and new animal drugs under FDA regulations is covered in this draft guidance, which is information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties. When it is finalized, the guidance for industry titled Computerized Systems Used in Clinical Investigations will be replaced by the draft guidance for industry titled Use of Electronic Documents and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers (May 2007).
The guidance offers suggestions regarding the rules, including those outlined in 21 CFR part 11, according to which the FDA considers electronic systems, electronic records, and electronic signatures to be generally equivalent to paper records and handwritten signatures executed on paper and trustworthy, reliable, and so on.
Source: https://www.fda.gov/media/166215/download
News from EDQM “EDQM is conducting consultation on Council of Europe recommendation on remote and online medicine provision.”
Date of news: March 15, 2023
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a targeted consultation from 13 March to 26 May 2023 to seek the opinions of interested parties on a draft Council of Europe recommendation on best practices for the remote and online provision of medicines. The main goal of the recommendation is to provide guidance on minimum requirements to be fulfilled by stakeholders involved in the medication process to allow safe and equal access to medicines at a distance, but also to raise awareness of existing issues that may require action. This consultation is a valuable opportunity for stakeholders to express their views and inform the process, allowing the EDQM to finalise the draft recommendation in the most relevant manner possible.
FDA published guideline “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry”
Date of news: March 16, 2023
The Federal Food, Drug, and Cosmetic Act (FD&C Act) was changed by the Drug Supply Chain Security Act (DSCSA), Title II of Public Law 113-54, to set procedures for product tracking, verification, and identification for some drug goods marketed in the US. Section 581 of the FD&C Act provides definitions for many of the terminology used in these regulations (21 U.S.C. 360eee).
Source: https://www.fda.gov/media/111468/download
FDA published draft guideline “Pharmacogenomic Data Submissions”
Date of news: March 17, 2023
The Food and Drug Administration (FDA) has made a draft industry guidance document called “Pharmacogenomic Data Submissions” available. The goal of this draft guidance is to make pharmacogenomics research and the use of pharmacogenomic data in medication development easier. The goal of the proposed advice is to make it clearer how the FDA’s rules should be followed when submitting information for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs). This document also offers suggestions to applicants and sponsors regarding the structure and content of pharmacogenomic data submissions.
Source: https://www.fda.gov/media/166258/download
News from ICH “The ICH S12 Guideline reaches Step 4 of the ICH Process”
Date of news: March 17, 2023
Step 4 of the ICH Process for the ICH S12 Guideline on “Nonclinical Biodistribution Issues for Gene Therapy Products” was reached on March 14, 2023.
In accordance with the 3Rs (reduce/refine/replace) philosophy, this guideline aims to provide guidance on the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products that mediate their effect by the expression (transcription or translation) of transferred genetic materials, as well as unified recommendations to facilitate the development of GT products.
The S12 EWG has created a Step 4 Introductory Training Presentation to summarize the Guideline’s content.
Further details, such as the guideline and the Step 4 introductory training presentation, are available on the S12 page.
Source: ICH S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
Pharma GMP News of the Week: 12-March-2023
Period: March 05, 2023 to March 11, 2023
FDA published “Guidance for Industry: Labeling of Infant Formula”
Date of news: March 6, 2023
The Food and Drug Administration is issuing this reminder to infant formula makers and distributors (“you”) about certain infant formula labelling requirements. While this guidance explains the labelling standards for infant formula products in general, we are particularly concerned about the number of infant formula products that have the same or similar claims of identity but differ in composition or intended use. We’ve also witnessed an upsurge in the use of nutrient content claims, which constitute misbranding under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document contains information that can assist you in understanding and complying with relevant labelling regulations.
Source: Labeling of infant formula: guidance for industry
EMA published “Questions and Answers about the raw data proof-of concept pilot for industry”
Date of news: March 7, 2023
This is a guide that answers frequently asked questions about the proof-of-concept pilot for clinical studies. The pilot involves submitting and analyzing “raw data” from selected initial marketing authorization applications and post-authorization applications to the European Medicines Agency. The guide is specifically related to the “Information about the raw data proof-of-concept pilot for industry.”
Source: Questions and Answers about the raw data proof-of-concept pilot for industry
MHRA published “Fees payable to the MHRA for 2022 to 2023”
Date of news: March 8, 2023
MHRA published 39 types of Fees payable to the MHRA for 2022 to 2023.
Source: Current MHRA fees – GOV.UK
FDA published “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry”
Date of news: March 10, 2023
The FDA has created a guide for drug companies called “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” This guide is about drugs called ARAs, like antacids, histamine H2-receptor antagonists, and proton pump inhibitors (PPIs), which are often used and can be bought without a prescription. ARAs can change the pH level in your stomach, which can affect how well other drugs work or if they are safe. It’s important to study these interactions early in drug development and share the results with doctors and patients. This guide explains when clinical studies should be done with ARAs, how to design and conduct those studies, and how to apply the results to different types of ARAs.
Pharma GMP News of the Week: 5-March-2023
Period: February 26, 2023 to March 4, 2023
News from EDQM “The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event”
Date of news: February 27, 2023
For certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)), the European Medicines Agency (EMA) has started a pilot programme to provide scientific advice on the intended clinical development strategy and proposals for clinical investigation. Manufacturers can now submit a letter of interest to take part in a pilot project involving scientific guidance from panels of experts in medical devices.
To read in detail, refer to the following link.
Source: The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event
News from EMA “Agency pilots scientific advice for certain high-risk medical devices”
Date of news: February 27, 2023
For certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)), the European Medicines Agency (EMA) has started a pilot programme to provide scientific advice on the intended clinical development strategy and proposals for clinical investigation. Manufacturers can now submit a letter of interest to take part in a pilot project involving scientific guidance from panels of experts in medical devices.
Source: EMA pilots scientific advice for certain high-risk medical devices | European Medicines Agency
News from European Commission “political agreement in principle on the Windsor Framework, a new way forward for the Protocol on Ireland / Northern Ireland”
Date of news: February 27, 2023
According to modifications to the Brexit deal reached by the UK and the EU, the UK Medicines and Healthcare products Regulatory Agency (MRHA) is now in charge of regulating human medicines in Northern Ireland.
Source:
- Questions and Answers: political agreement in principle on the Windsor Framework, a new way forwardfor the Protocol on Ireland / Northern Ireland
- https://www.gov.uk/government/news/windsor-framework-unveiled-to-fix-problems-of-the-northern-ireland-protocol
News from EDQM “Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts”
Date of news: February 27, 2023
The Pharmacopoeial Discussion Group (PDG), as stated in the press release on January 6, 2023, met for its yearly autumn conference from October 18–21, 2022. The World Health Organization (WHO) was present as an observer, along with the three founding members of the PDG—the European Pharmacopoeia (Ph. Eur. ), the Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP)—as well as the Indian Pharmacopoeia Commission (IPC), which was a participant in the PDG pilot for international expansion.
See the press release titled “Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts” for complete information regarding the individual work programme sign-offs.
MHRA has announced Graduate Scheme on its website
Date of news: February 28, 2023
The three-year MHRA Graduate Programme is a graduate development programme that offers an exciting chance to make a significant contribution to patient safety and public health protection. You would contribute to:
– Facilitating the rapid and flexible development of medical products in support of the government’s objective for life sciences innovation.
– Critically evaluating the advantages and disadvantages of drugs and medical devices in order to make wise choices on the standard and accessibility of healthcare.
– Making use of effective vigilance procedures that may promptly identify, track, and assess any negative effects and issues relating to medications and medical equipment.
Source: MHRA Graduate Scheme – GOV.UK
FDA published “Q13 Continuous Manufacturing of Drug Substances and Drug Products”
Date of news: March 1, 2023
This recommendation outlines scientific and legal factors to take into account when developing, implementing, running, and managing the lifecycle of continuous manufacturing. In addition to providing clarification on CM principles, this guideline outlines scientific techniques and regulatory considerations unique to CM of drug substances and drug products, building on earlier International Council for Harmonization (ICH) Quality guidances.
Source: https://www.fda.gov/media/165775/download
FDA published draft guidance “Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens”
Date of news: March 1, 2023
In order to help sponsors create monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins driving pathogenic mechanisms of infection, this guidance is intended to offer suggestions. The creation and implementation of a potency assay (or assays) sufficient to verify that each lot is generated consistently with the potency required to achieve clinical efficacy and that such potency is maintained over the product’s shelf life is a crucial quality control measure for these products. With the aim of assisting in ensuring that medication developers provide appropriate information to assess potency at each step of a product’s life cycle, this guidance offers specific recommendations to drug developers.
Source: https://www.fda.gov/media/165746/download
News from EDQM “European Pharmacopoeia Commission creates new Excipients Strategy Working Party”
Date of news: March 1, 2023
The development of a new Excipients Strategy Working Party (EXS) was authorised by the European Pharmacopoeia Commission (EPC) during its 173rd session in June 2022 (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The European Pharmacopoeia (Ph. Eur.) excipient strategy will be further developed by the EXS Working Party, which will continue to address the specifics of these significant pharmaceutical constituents in Ph. Eur. monographs.
MHRA published “Response template for applicants”
Date of news: March 3, 2023
The applicant should prepare the answers to the MHRA questions by compiling them verbatim into this response template, just as they have been introduced in the Request for Further Information (RFI) or the Commission on Human Medicines (CHM) Letter.
There should be as many copies of each component (question, applicant response, and assessor remark box) as there are questions under each pertinent subject. Even if they are on the list of questions, ASMF-related inquiries need to be addressed separately using this response template.
Pharma GMP News of the Week: 26-February-2023
Period: February 19, 2023 to February 25, 2023
EMA published “Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)”
Date of news: February 9, 2023
With the purpose of guiding sponsors through the Clinical Trials Regulation (CTR) and the new clinical trials information system (CTIS) portal, the European Medicines Agency (EMA) has released guidance in the form of a question-and-answer document. On January 31, the CTIS had to be used.
The Query Management Working Group (QMWG) of the European Medicines Agency (EMA) created the Q&A in order to address some of the concerns raised by stakeholders, including the Association of Clinical Research Organizations (ACRO), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and the European Clinical Research Organization Federation (EUCROF).
US FDA Center for Devices and Radiological Health published six final guidelines
Date of news: February 21, 2023
Pharma GMP News of the Week: 19-February-2023
Period: February 12, 2023 to February 18, 2023
MHRA Inspectorate Blog published 25+ Frequently Asked Questions on related to “Manufacture of Investigational Medicinal Products”
Date of news: February 3, 2023
MHRA Clinical Trials and GMP and GCP Inspectors collaborate closely, and they frequently offer assistance in response to stakeholder questions about the production, importation, labelling, licencing requirements, and general handling of Investigational Medicinal Goods (IMPs).
This “frequently asked questions” blog post about the production and distribution of IMPs was originally published by us in 2016. It was based on a prior MHRA website article. We decided it would be good to examine and update this blog because there have been some changes since it was first published, such as the implementation of an import oversight procedure for IMPs with QP certification entering Great Britain from authorised nations.
Source: Manufacture of Investigational Medicinal Products – Frequently Asked Questions – MHRA Inspectorate
News from EDQM “Public consultation on Ph. Eur. rabbit pyrogen test replacement texts in Pharmeuropa 35.1”
Date of news: February 13, 2023
For public discussion in Pharmeuropa 35.1 with a comment deadline of March 31, 2023, the European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) involved in the rabbit pyrogen test (RPT) replacement strategy.
These texts, which cover a wide range of subjects like human-use vaccines, blood products, antibiotics, radiopharmaceuticals, and containers, have been updated to swap out the RPT for an alternative in vitro test like the monocyte activation test (MAT) or another method that is sympathetic to animal welfare. Their release represents an important development in the plan established by the Ph. Eur. Commission in June 2021, which is expected to eventually result in the total replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., anticipated within the next three years.
In more detail, this goal and how it will be accomplished are covered in the pyrogenicity strategy paper that was released in September 2022.
News from EDQM “The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023”
Date of news: February 14, 2023
Since January 1, 2023, the 10th Edition of the European Pharmacopoeia (Ph. Eur. As a result, starting on January 31, 2023, no one can access the 10th Edition online or any of its predecessors, including the Ph. Eur. archives for 10th Edition users.
On the specific European Pharmacopoeia online site, subscribers can access the Ph. Eur. 11th Edition and its supplements. Users with a current membership (11th Edition) can still consult out-of-date Ph. Eur. materials in the Ph. Eur. archives accessible through the new site..
Source: https://www.edqm.eu/en/-/shutdown-of-european-pharmacopoeia-10th-edition
EMA Published highlights of 2022 on Human medicines
Date of news: February 16, 2023
89 medications were suggested by the EMA for marketing authorization in 2022. Of them, 411 contained a novel active ingredient that had never before received authorization from the European Union (EU). A list of novel medications that have made substantial strides in their therapeutic fields is included in the PDF icon overview of the 2022 main recommendations that was released today.
EMA and the EU Member States regularly monitor a drug’s quality and benefit-risk balance after the European Commission grants it approval and authorises it for use in patients. When necessary, they take appropriate regulatory action. A limited number of batches may be recalled, a medicine may be suspended or removed, or the product information may be changed. An overview of some of the most notable safety-related recommendations is also included in the document.
Source: https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2022_en.pdf
FDA Published Draft Guidance “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA”
Date of news: February 17, 2023
In accordance with section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), this guidance offers recommendations to the industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant who is preparing to submit to FDA or an applicant who has already submitted an abbreviated new drug application (ANDA). The Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Objectives and Program Enhancements Fiscal Years 2023–2027, in particular, give information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings) (GDUFA III commitment letter). Additionally, this advice aims to provide guidelines for managing PSG meetings efficiently, ensuring that they are scheduled and run in compliance with the
Pharma GMP News of the Week: 12-February-2023
Period: February 5, 2023 to February 11, 2023
Actions of EMA to support the development of medicines for children
Date of news: February 6, 2023
In the past four years, regulators in the European Union (EU) have undertaken a number of initiatives to improve the effectiveness of paediatric regulatory processes and accelerate the development of paediatric medications. The EMA and European Commission (EC) action plan on paediatrics’ concluding report, which is available in PDF format, highlights these accomplishments.
The paediatric action plan has made some significant advancements, such as:
i. A stronger emphasis on unmet medical needs.
ii. Adapting legal procedures to better encourage innovation.
iii. Increasing agreement among decision-makers regarding the need for data.
Source: https://www.ema.europa.eu/en/news/actions-support-development-medicines-children
News from EDQM “A High Throughput Sequencing-specific working team is created by the Ph. Eur. Commission”
Date of news: February 9, 2023
The European Pharmacopoeia (Ph. Eur.) Commission resolved to establish a new Working Party on High Throughput Sequencing (HTS) in November 2022. This group will be in charge of developing a general chapter on HTS for the identification of viral extraneous agents. The new general chapter should make it easier to employ this cutting-edge technology, also called as NGS, as a new analytical instrument to guarantee the viral safety of biological treatments. It has a broad virus detection capabilities.
Those with expertise in HTS for the detection of foreign agents in biologicals and in the development and validation of analytical procedures based on HTS (for example, from licencing authorities, official medicines control laboratories, or industry) are invited to apply to join the new Working Party on this crucial journey to improve the safety and efficacy of pharmaceuticals..
FDA Published Final Guidance “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act”
Date of news: February 9, 2023
This guideline outlines the regulatory and enforcement priorities of the FDA with regard to the outsourcing of the compounding of specific ibuprofen oral suspension products for use in hospitals and health systems. Three viruses—influenza, respiratory syncytial virus (RSV), and coronavirus disease 2019—are currently on the rise in the United States. Young children may develop fever from any of these viruses. The FDA has been informed of an upsurge in demand for products containing ibuprofen oral suspension for treating paediatric fevers. Additionally, the FDA has heard from a number of hospitals and health systems that are having trouble getting these medications to treat fever in children as well as adults who are unable to take solid oral pills.
Additionally, hospitals and health systems have reported difficulties obtaining these medications for use in treating fever in children as well as adults who are unable to swallow solid oral dosage forms (e.g., people with feeding tubes) as a result of, for instance, regional differences in infection rates, resource distribution, or other regional conditions that may change rapidly during the winter months. FDA plans to update, alter, or remove this policy as necessary if the relevant needs and circumstances change. FDA is constantly evaluating the needs and circumstances connected to the temporary policy outlined in this guideline.
FDA Published Draft Guidance “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development”
Date of news: February 10, 2023
This recommendation is intended to provide a framework for debating whether and what kinds of long-term neurologic, sensory, and developmental evaluations might be helpful to support a determination of the safety of a drug, biological product, or device (referred to in this recommendation as a “medical product”) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.
The efficacy or effectiveness of medications whose primary goal is to improve neurologic outcomes, such as neuroprotective drugs, will not be particularly addressed by this guideline. The emphasis of this advice is on long-term assessments of neurodevelopmental safety. Although evaluations of nephrotoxicity, pulmonary toxicity, and toxicity to other tissues and organs may also be required in the development of neonatal medical products, the methodology for those evaluations is outside the purview of this article.
Source: https://www.fda.gov/media/165239/download
News from EMA “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9 February 2023 ”
Date of news: February 10, 2023
Source: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-february-2023
Pharma GMP News of the Week: 5-February-2023
Period: January 29, 2023 to February 4, 2023
In-person formal meetings with the FDA will resume in February.
Date of news: January 30, 2023
News from EDQM – CEP holders – How to submit a nitrosamine risk assessment
Date of news: January 30, 2023
The European Directorate for the Quality of Medicines & Healthcare (EDQM) would like to call CEP holders’ attention to the following information regarding minor amendments in order to assist the prompt acceptance of suggested changes.
Minor revisions should be submitted for updated discussions on impurities in section 3.2.S.3.2 or for submission of nitrosamine risk assessments (the deadline for the latter was 31 July 2020; for more information, see the news article from 27 March 2020 titled “Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)”). Additionally, CEP holders are reminded that changes to the synthesis or the control strategy should be classified appropriately in accordance with the EDQM guideline in order to prevent or completely eliminate the possibility of the production of nitrosamine impurities or other mutagenic impurities (minor, major revision or sister file application).
EC published Video recordings and presentations of Multistakeholder Event of Biosimilar medicines (13 December 2022)
Date of news: January 30, 2023
Source: Biosimilar medicines – Multistakeholder Event
EC Published “Clinical Trials Regulation (EU) No 536/2014 in practice”
Date of news: January 30, 2023
This is a brief overview of the key provisions of the Clinical Trials Regulation (EU) No 536/2014 (CTR) for sponsors with ongoing or planned national or international clinical trials in the European Union (EU) or European Economic Area (EEA). The Eudralex Volume 10 website publishes the list of papers that apply to clinical trials authorised under Regulation (EU) No 536/2014. The Questions and Answers document – Regulation 536/2014 (Q&A -CTR) in chapter V is the first document that is suggested for reading. Chapter 6 provides additional documents (guidelines, guidances, suggestion papers, and Q&As) to be taken into consideration.
US FDA published draft guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
Date of news: January 31, 2023
This guideline is meant to offer suggestions on how to conduct bioequivalence (BE) studies for orally administered immediate-release (IR) 5 solid oral dosage forms intended to deliver medications to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension, during both the development and post approval phases.
Source: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
MHRA has published “Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees“
Date of news: January 31, 2023
In accordance with Section 45(1) of the Medicines and Medical Devices Act 2021, the MHRA coordinated a joint consultation with the Department of Health in Northern Ireland on proposed changes to the MHRA’s statutory fees.
The consultation sought opinions on proposed changes to the statutory fees levied for the MHRA’s regulatory services between August 31, 2022, and November 23, 2022. According to the Rules for Managing Public Money, the fees are determined on a cost recovery basis; nevertheless, they have not been revised in a while and do not fully recover expenses.
News from EDQM “SNOMED International and the EDQM collaborate on map development”
Date of news: January 31, 2023
An agreement controlling the development, upkeep, and dissemination of a map connecting the terminologies of both organisations has been signed by SNOMED International and the European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe. September 2022 saw the implementation of the accord.
News from EMA “Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU”
Date of news: January 31, 2023
All initial clinical trial applications in the European Union (EU) must be submitted through the Clinical Trials Information System starting on January 31, 2023. (CTIS). For the submission and evaluation of clinical trial data, CTIS is now the single point of entry for sponsors and regulators of clinical studies. This comes after an interim period of one year during which sponsors could decide whether to submit an application for a new clinical trial in the EU/EEA in accordance with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which took effect on January 31, 2022.
MHRA has published guidance “Completed Paediatric Studies – submission, processing and assessment”
Date of news: February 1, 2023
MHRA published Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Source: Completed Paediatric Studies – submission, processing and assessment – GOV.UK
New GDP Guidance Documents are adopted and put into effect by PIC/S.
Date of news: February 1, 2023
An “Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain” (PI 044-1) and a “Questions & Answers (Q&A) document regarding the PIC/S GDP Guide” (PS/INF 22/2017) are two documents that PIC/S has released as guidelines for GDP inspectors. The PIC/S Expert Circle on GDP, headed by Karen Ford (South Africa / SAHPRA), created these documents, which will take effect on February 1st, 2023.
Source:
- AIDE – MEMOIRE INSPECTION OF GOOD DISTRIBUTION PRACTICE (GDP) FOR MEDICINAL PRODUCTS IN THE SUPPLY CHAIN
- Questions & Answers for PIC/S GDP Guide Q&A Document
News from EDQM “Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures”
Date of news: February 1, 2023
Two texts dealing with pharmaceutical technology, one revised and one new, have recently been published in Pharmeuropa 35.1 for public consultation.
- Revision of the harmonised general chapter 2.9.3. Dissolution of tablets and capsules
- New general chapter 2.9.55. Characterisation of powder behaviour during compression
US FDA published draft guideline “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products”
Date of news: February 2, 2023
This guidance offers suggestions to sponsors and researchers thinking about using externally controlled clinical trials to demonstrate the efficacy and safety of a new product. In an externally controlled study, results are compared between participants who got the test therapy in accordance with a protocol and a group of individuals outside the experiment who had not received the same treatment. The external control arm may consist of a group of people who have received treatment or have not (historical control) or it may consist of a group who have received treatment or have not (concurrent control) during the same time period but in a different location.
News from EMA “A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies”
Date of news: February 2, 2023
As of today, February 2, 2023, EMA will also be in charge of monitoring and reducing shortages of essential medical equipment during situations involving a public health emergency. The new requirements are the final piece of Regulation (EU) 2022/123 to be implemented, which strengthens the EMA’s involvement in crisis management of vital pharmaceuticals and medical devices during public health emergencies.
News from EMA “Public consultation on a multi-stakeholder platform to improve clinical trials in the EU”
Date of news: February 3, 2023
A public consultation on the creation of a multi-stakeholder platform to enhance clinical trials in the European Union is set to begin on February 3, 2023, by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission (EC) (EU). A deliverable of the collaborative project Accelerating Clinical Trials in the EU is the multi-stakeholder platform (ACT EU).
Collaboration amongst a variety of stakeholders is necessary for successful clinical studies. In order to improve the clinical trials landscape for innovation and the benefit of all European people, the establishment of a unified platform will facilitate interactions between stakeholders at the EU level. This will foster a shared understanding and enable concerted action.
Source: https://www.ema.europa.eu/en/news/public-consultation-multi-stakeholder-platform-improve-clinical-trials-eu
20+ Helpful Online Courses for Pharmaceutical Industry Professionals Development
Following are 20+ Helpful Courses for Pharmaceutical Industry Professionals Development. The courses are carefully checked considering the rating on Udemy, and number of students tool the course for their professional development.
Professional development courses are the perfect investment for your professional growth and success. Here are three reasons why you should upskill yourself.
- It helps you to stay ahead in your field with the latest developments and best practices.
- Provides hands-on training and practical insights to improve your skills to become more effective in your job.
- Regular upskilling will demonstrate that you are committed to professional development, which can help you stand out in your field and lead to new job opportunities and promotions.
Checkout following courses to upskill yourself, stay ahead in your field, achieve your personal and professional goals.
| Sr. No. | Course Name | Course Created by | Minimum nos. of Participants have taken the course | Course Rating (out of 5) |
| 1 | Your Guide to the Pharmaceutical Industry | Phil Yates | 7,813+ students | 4.4 |
| 2 | Certificate Course in Drug Regulatory Affairs (DRA) | Dr. Sachin Potawale | 4,541+ students | 4.1 |
| 3 | Basic Good Manufacturing Practices (GMP) | Ruben Alonso | 2,264+ students | 4.2 |
| 4 | Medical Device Process Validation. ISO 13485. IQ OQ PQ | Martin Conneely | 2,035+ students | 4.4 |
| 5 | Medical Device Regulation 2017/745 EU regulatory affairs | Martin Conneely | 1,835+ students | 4.6 |
| 6 | Practical Regulatory Affairs 2020 – European Medical Devices | Pubudi Silva | 1,255+ students | 4.3 |
| 7 | The Pharmaceutical R&D Process in Healthcare | James Mitroka | 1,169+ students | 4.5 |
| 8 | Computerised System Validation (CSV) | Hitendrakumar Shah | 1,102+ students | 3.9 |
| 9 | Medical Device Regulations | SequenceCentral – IT Training and Consulting | 1,242+ students | 4.1 |
| 10 | Master pharmaceutical quality management system | Dr. Zahra Hassan | 336+ students | 4.2 |
| 11 | Certificate Course in Pharmaceutical Quality Assurance | Ateos Foundation of Science Education and Research | 307+ students | 3.8 |
| 12 | How to audit GMP systems | Ruben Alonso | 273+ students | 4.6 |
| 13 | Good Laboratory Practices | Hitendrakumar Shah | 127+ students | 3.3 |
| 14 | Good Storage Practices for Pharmaceuticals | Hitendrakumar Shah | 36+ students | 4.4 |
| 15 | Job Oriented Certificate Course in Pharmacovigilance | PV Drug Safety Academy | 79+ students | 4.3 |
| 16 | Certificate Course in Pharmacovigilance | Srikanth Gorantla | 1,144 students | 4.4 |
| 17 | Medical Writing for Healthcare Professionals | Alex Evans, PharmD, MBA | 1,971 students | 4.5 |
| 18 | Clinical Research for beginners | Dr Sabyasachi Sengupta | 2,236 students | 4.1 |
| 19 | Complete Introduction to Google Data Studio 2023 Edition | Ian Littlejohn | 19,758 students | 4.6 |
| 20 | Google Sheets – The Comprehensive Masterclass | Leila Gharani | 26,729 students | 4.8 |
| 21 | Statistical Process Control (SPC) Using Microsoft Excel | Ray Harkins, The Manufacturing Academy | 5,273 students | 4.5 |
Udemy courses are an excellent way to upskill and professional development. Udemy is an online learning platform that offers various courses on diverse topics. These courses are created to help individuals acquire new knowledge, skills, and expertise and advance their careers.
One of the key benefits of Udemy courses is their accessibility.
Udemy courses can be taken from anywhere and at any time, making them an ideal solution for busy individuals looking to upskill for a professional carrier. The individuals can study and learn at their own pace without worrying about scheduling conflicts and other obligations.
Another advantage of Udemy courses is the extent of topics that they cover. Udemy courses are available for almost all subjects you would think of, such as business, technology, design, health and wellness, and many others.
This means that individuals can find courses relevant to their specific interests and goals and pick courses that align with their professional aspirations.
Udemy courses are also highly affordable compared to traditional forms of education, such as college or university courses.
In addition to the affordability of Udemy courses, they are also developed to be interactive and engaging.
Udemy courses often include videos, quizzes, and interactive exercises, making the learning experience fun and engaging.
Finally, Udemy courses offer individuals a certificate of completion, which can be added to their professional portfolios. This certificate can demonstrate their commitment to furthering their education and can be a valuable asset in their professional lives.
In conclusion, Udemy courses are a highly accessible and affordable way for individuals to further their education and advance their careers.
For pharmaceutical professionals, the course will help in several ways as follows:
- Enhance knowledge: The courses offer in-depth expertise on a range of subjects related to the pharmaceutical sector, including pharmacology, quality control, regulatory affairs, and drug development.
- Career advancement: Pharmacists who pass these courses will be able to further their careers and find new employment options by demonstrating their dedication to lifelong learning.
- Stay updated: These courses can assist professionals in keeping abreast of the most recent advancements and best practices in the pharmaceutical industry, a constantly growing field.
- Improve skills: The courses provide practical instruction and insights into a range of pharmaceutical business facets, which can assist professionals to sharpen their skills and perform better in their current positions.
These courses can help professionals to achieve their personal and professional goals.
Pharma GMP News of the Week: 29-January-2023
Period: January 22, 2023 to January 28, 2023
News from EMA “Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications”
Date of news: January 19, 2023
The usage of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications on January 31, 2023, and will serve as the single point of entry for submission by sponsors and regulatory assessment. This comes after a one-year transition period in which sponsors could choose whether to submit a new clinical trial application in accordance with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which took effect on January 31, 2022.
FDA published guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry”
Date of news: January 23, 2023
This guidance provides the FDA’s current thinking on a variety of clinical research topics linked to the development of human medicines including cannabis or cannabis-derived substances. A drug, according to section 201(g) of the FD&C Act, is any product designed to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to change the structure or function of the body. In general, any product (including those containing cannabis or cannabis-derived substances) that is promoted with a therapeutic benefit claim or any other disease-related claim is considered a medication.
To be legally marketed in interstate commerce, drugs that are not biological products must either (1) receive premarket approval from the FDA through the new drug application (NDA) or abbreviated new drug application (ANDA) process, or (2) meet the requirements in the FD&C Act for marketing without an approved NDA or ANDA for certain over-the-counter nonprescription drugs. The recommendations in this advice are intended for goods that meet the FD&C Act’s legal definition of a drug.
Source: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
News from EU “ EU survey on the implementation of the Clinical Trial Regulation”
Date of news: January 23, 2023
News from EDQM “European Paediatric Formulary published new monograph on Simple syrup (preservative-free)”
Date of news: January 25, 2023
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has introduced a new monograph to the European Paediatric Formulary, Simple syrup (preservative-free). The monograph was authorised by the European Pharmacopoeia Commission at its 174th session in November 2022, and it was just adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). Simple syrup, which is widely used in Europe, was also utilised as the vehicle for some of the original PaedForm monographs.
Source: European Paediatric Formulary: Simple syrup (preservative-free) monograph published
News from EU “A Commission decision adopted today will contribute to improve the quality of medicines in the EU. It allows trusting on the quality of active substances produced in Canada”
Date of news: January 26, 2023
Active chemicals made in third countries such as Canada and intended for human medicines placed on the EU market must be manufactured in an EU similar regulatory regime that includes criteria for good manufacturing practises (GMP).
Third countries can ask the Commission to assess whether their regulatory framework and related control and enforcement activities provide a level of public health protection comparable to that of the Union, as Health Canada/Santé Canada, a federal department of the Canadian Ministry of Health, requested in October 2018.
Source: Improving the quality of medicines
News from ICH “Module I – Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video is now available on the ICH website”
Date of news: January 23, 2023
Module I – Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video has been released by the ICH Secretariat.
The Training Video is available for download, and more material is accessible on the ICH E2B(R3) EWG website.
Source: https://database.ich.org/sites/default/files/E2B%20Module%20I%20Final%20-1080-%202023_0123.mp4
News from ICH “The updated ICH E2B(R3) Q&As reach Step 4 of the ICH Process”
Date of news: January 23, 2023
The ICH Secretariat is happy to inform that the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has passed Step 4 of the ICH Process as of the 17th of January 2023.
Source: https://database.ich.org/sites/default/files/ICH_E2B-R3_QA_v2_4_Step4_2022_1202.pdf
Press release from MHRA “UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care”
Date of news: January 25, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) stated today that the United Kingdom will be the first country to implement a bespoke framework for the regulation of innovative products made at the point of care. This means that new medications with very short shelf life and highly personalized treatments can be manufactured in or near a hospital setting or ambulance and delivered to patients much more swiftly.
News from ICH “The ICH M13A draft Guideline presentation available now on the ICH website”
Date of news: January 26, 2023
The M13 Expert Working has produced a Step 2 Informational Presentation in response to the ICH M13A draught draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.
More information is available on the M13 page, including a copy of the Step 2 Informational Presentation.
Source: https://database.ich.org/sites/default/files/ICH_M13A_Step2_draft_Guideline_2022_1125.pdf
News from ICH “The ICH Q13 Introductory Training Presentation is now available on the ICH website”
Date of news: January 26, 2023
On November 16, 2022, the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process.
Following the acceptance of this Guideline, the Q13 Expert Working Group created a Step 4 Introductory Training Presentation.
The presentation is available for download on the Quality Guidelines website.
Source: https://database.ich.org/sites/default/files/ICH%20Q13_Step_4_Presentation_2023_0112_0.pdf
Pharma GMP News of the Week: 22-January-2023
Period: January 15, 2023 to January 21, 2023
FDA has published draft “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases”
Date of news: January 17, 2023
This guidance is intended to assist sponsors in determining the best dosage(s) for human prescription medicines or biological products in clinical development for the treatment of oncologic illnesses prior to filing an application for approval for a new indication and usage. This guidance does not cover dosage optimization for radiopharmaceuticals, cellular and gene therapy products, microbiota, or cancer vaccines, nor does it address dosage selection for first-in-human trials.
MHRA Press release “MHRA increases UK assessment capacity for in-vitro diagnostic devices”
Date of news: January 18, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that UL International UK Ltd has been designated to assess the majority of in-vitro diagnostic (IVD) devices, increasing the UK’s capacity to process conformity assessments and ensure safe and effective IVDs reach the UK public.
Source: MHRA increases UK assessment capacity for in-vitro diagnostic devices – GOV.UK
MHRA has updated information on how to submit the SAE reporting form
Date of news: January 18, 2023
Source: Notify the MHRA about a clinical investigation for a medical device – GOV.UK
EDQM has rolled out user satisfaction survey for review on revamped EDQM website
Date of news: January 18, 2023
Over nine months ago, on 1 April 2022, the European Directorate for the Quality of Medicines and HealthCare (EDQM) launched its new website. You’ve had time to explore what the new website has to offer, therefore the EDQM is looking for your input via an anonymous customer satisfaction survey. Visit the following link to participate in the survey.
Source: https://www.edqm.eu/en/-/user-satisfaction-survey-revamped-edqm-website
News from EDQM “Call for experts – Aluminium in parenteral nutrition solutions”
Date of news: January 19, 2023
Although several European countries control aluminium in parenteral nutrition solutions (PNS), there are currently no European rules restricting the maximum amount of aluminium in these solutions, which are frequently manufactured on the spot. To address this issue, the European Pharmacopoeia (Ph. Eur.) is looking for qualified professionals with experience in PNS and parenteral preparations, particularly those with experience in quality and toxicological assessment of aluminium content, to join the newly formed Aluminium in Parenteral Solutions Working Party (ALU WP). This WP will be in charge of creating a new general chapter on aluminium in parenteral nutrition solutions in order to reduce the danger of exposure to harmful levels of aluminium. The document is also expected to provide instructions for individuals who will prepare and administer these solutions.
Source: https://www.edqm.eu/en/-/call-for-experts-aluminium-in-parenteral-nutrition-solutions
FDA has published draft “Mpox: Development of Drugs and Biological Products; Guidance for Industry”
Date of news: January 19, 2023
The FDA is publishing this guidance to assist sponsors in developing drugs for mpox. This document includes nonclinical, virology, and clinical considerations for mpox medication development initiatives, with a focus on suggestions to assist clinical trial commencement.
Source: https://www.fda.gov/media/164642/download
FDA has published “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act”
Date of news: January 19, 2023
Source: https://www.fda.gov/media/164693/download
News from EDQM “Supplement 11.2 of the European Pharmacopoeia (Ph. Eur.) is now available”
Date of news: January 20, 2023
Source: Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders
News from ICH “The ICH Q9(R1) Guideline reaches Step 4 of the ICH Process”
Date of news: January 20, 2023
This Guideline is intended to provide direction on the principles of quality risk management and examples of methods that can be applied to various elements of pharmaceutical quality.
Development, manufacturing, distribution, and the inspection and submission/review processes for drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging, and labelling materials in drug (medicinal) products, biological and biotechnological products) are all included.
Source: https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf
The US Food and Drug Administration adopted a final regulation that drastically cuts record-keeping requirements for medical devices like x-rays.
Date of news: January 20, 2023
The Food and Drug Administration (FDA, Agency, or we) is amending and repealing portions of the radiological health regulations that cover recommendations for radiation protection during medical procedures, certain electronic product records and reporting, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update regulations in order to remove outmoded regulatory requirements that duplicate other measures of protecting public health from dangerous exposure to radiation emitting electronic gadgets and medical devices.
MDCG issues recommendations on notified body postings of standard MDR and IVDR Fees
Date of news: January 2023
MDCG has issued guidance on how notified entities can meet the requirement to publish their rates for medtech regulatory services.
Source: MDCG 2023-2 List of standard fees
Pharma GMP News of the Week: 15-January-2023
Period: January 8, 2023 to January 14, 2023
The Medical Device Coordination Group (MDCG) has published guidance on the application of the medtech legislation to devices and diagnostics produced and used by healthcare organisations in the European Union.
Month of news: January 2023
The majority of the article is devoted to determining what constitutes a suitable quality management system (QMD) for in-house devices. Under an acceptable QMS, health institutions must produce and use in-house devices. The MDCG guidance includes examples of topics covered by a suitable QMS, such as risk management and traceability, as well as details on what is necessary in each area.
The EMA has amended its good distribution practises (GDPs) advice to explain how the rules apply to brokers operating outside of the European Economic Area (EEA).
Month of news: January 2023
Two new questions about GDP needs are included in the paper. The new issues cover whether a broker can broker operations between parties outside the EEA, as well as whether a broker can broker activities for medicinal products without an EEA marketing license but with an EEA marketing authorization.
The answer is no to both queries. In clarifying the answers, the EMA referred to its GDP recommendations from 2013. Both suppliers and clients must be based in the EEA, according to the standards. Brokering operations between suppliers and clients outside the EEA are not covered by EU law. Similarly, for the requirements to apply, a pharmaceutical product must obtain a marketing authorisation in at least one EEA nation.
News from EDQM “Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines”
Date of news: January 6, 2023
The European Pharmacopoeia (Ph. Eur.) Commission adopted the updated general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) at its 174th session in November 2022. These monographs now include a section outlining the Ph. Eur. approach to N-nitrosamine impurities. This strategy was developed based on responses from the most recent round of public engagement in Pharmeuropa as well as recent statements from the heads of the European Medicines Agency and the Medicines Agency.
The updated monographs will appear in Ph. Eur. Supplement 11.3 and go into effect on January 1st, 2024. Now that the topic of nitrosamine control in individual monographs has been raised, the Ph. Eur. Commission will begin considering solutions.
The EMA has adopted the ICH guideline on continuous manufacturing
Date of news: January 6, 2023
The European Medicines Agency (EMA) has approved final international guidance on the continuous manufacture of drug substances and drug products, which will take effect in July.
Continuous production entails continuously feeding input materials into a system and continuously removing output materials from the manufacturing process. The strategy differs from the more often used stop-start batch production process, prompting the International Council for Harmonisation (ICH) to produce the Q13 continuous manufacturing standard.
Source: ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 5
News from EDQM “Ph. Eur. Commission welcomes Ethiopian FDA as observer”
Date of news: January 9, 2023
The Ethiopian Food and Drug Administration (EFDA) received observer status from the European Pharmacopoeia (Ph. Eur.) Commission during its 174th session (November 2022). This choice shows the dynamism of the European Pharmacopoeia, which today comprises 40 members and 31 observers from around the globe (39 European states and the European Union).
This status entitles EFDA representatives to take part in the scientific work of the European Pharmacopoeia Commission and other EDQM activities, benefit from the EDQM’s experience in the field of medicinal products for human and veterinary use, engage in discussions with experts from European and international licencing authorities and inspectorates, and work on the creation of global quality controls for medicines and the analytical techniques used.
EDQM published “Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022”
Date of news: January 9, 2023
On November 22 and 23, 2022, the European Pharmacopoeia Commission (EPC) conducted its 174th session. The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023) will publish the 85 documents that the Commission approved during this session, with an implementation date of 1 January 2024.
These 85 texts contained one new general chapter and 13 new monographs:
Monographs:
Dabigatran etexilate mesilate (3095); Levocetirizine dihydrochloride (3115); Bupivacaine (2761); Gallium (68Ga) oxodotreotide injection (3050); Gallium (68Ga) DOTA-NOC injection (3051); Eclipta prostrata (2852); Helichrysi flos (3089); Horse-chestnut bark (2945); Burdock root (2943); Adhatoda vasica leaf (2738); Lonicera japonica flower (3159); Chrysanthemum flower (3162);
General chapter:
Particle size analysis by image analysis (2.9.48).
It also adopted revised versions of 72 texts covering:
The general chapter Friability of uncoated tablets (2.9.7) and The general chapter Osmolality (2.2.35).
Source: Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022
FDA Published guideline “Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals”
Date of news: January 10, 2023
This document serves as industry guidance on the requirements for a foreign supplier verification programme (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to make sure that each food they import into the United States complies with applicable U.S. requirements and is not adulterated or (for human food) misbranded with regard to allergen labelling.
FDA Published draft guideline “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format”
Date of news: January 12, 2023
The Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format” draft guideline for industry is now available, according to the FDA.
The purpose of this advice is to help applicants create the DOSAGE AND ADMINISTRATION portion of labelling. This guideline is intended to help applicants make sure that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information required for a drug’s safe and effective use and that the information is presented in a way that is pertinent to and understandable to healthcare professionals. The industry guidance titled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format,” which was released on March 29, 2010, is being withdrawn.
EMA has published “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)” that has been held from 9 to 12 January 2023
Date of news: January 13, 2023
Following are Key Points:
- Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
- New safety information for healthcare professionals
- Zolgensma: fatal cases of acute liver failure
Pharma GMP News of the Week: 8-January-2023
Period: January 1, 2023 to January 7, 2023
The Central Drugs Standard Control Organization (CDSCO) requested that human vaccination firms submit summaries of their “established” pharmacovigilance systems
Month of News: December 2022
The New Drugs and Clinical Trials Rules, 2019 require each new medication imported or manufactured in India to have a pharmacovigilance system for collecting, processing, and reporting adverse drug reaction data to the central licencing body. The pharmacovigilance system must be administered by skilled and trained employees, and data processing must be overseen by a medical officer or pharmacist trained in collecting and evaluating adverse drug reaction reports.
Indian medical device testing facilities needs to enhance their capacity for evaluation
Month of News: December 2022
CDSCO has issued a request to laboratories that have been accredited by the National Accreditation Board for Testing and Calibration Laboratories and are capability and expertise for performing medical device work under the 2017 Medical Devices Rules (MDR). The FDA is searching for laboratories that meet these criteria in order to submit MDR, 2017 applications.
FDA Published guideline “Format and Content of a REMS Document Guidance for Industry”
Date of news: January 04, 2023
This guideline updates the structure and content of a risk assessment and mitigation strategy (REMS) document for a prescription medication product, including a biological drug product. A REMS document, which is part of a REMS needed by FDA, specifies the REMS’s aims and requirements.
Source: Guidance for Industry: Format and Content of a REMS Document
FDA Published guideline “REMS Document Technical Conformance Guide”
Date of news: January 04, 2023
This Technical Conformance Guide (Guide) for Risk Evaluation and Mitigation Strategy (REMS) Documents provides updated, detailed instructions on the format of a REMS Document, as well as standardised language that describes common REMS requirements for applicants to use whenever possible, to help ensure consistency and facilitate efficient review of the REMS Document. This Guide explains how to submit a REMS Document in Structured Product Labeling (SPL) format. Furthermore, this Guide includes an outline to help applicants create a Bifurcated REMS Document.
Pharma GMP News of the Week: 25-December-2022
Period: December 18, 2022 to December 24, 2022
EU Published guidance “EU Guideline on orphan applications (for designation and transfer) – 2022/C 440/02”
Date of news: December 19, 2022
This guideline provides further guidance on the information sponsors must supply when seeking for orphan medicinal product designation. It encompasses both the structure and the content of the application and should be followed unless there are compelling reasons to deviate from it.
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022XC1121(01)&from=EN
FDA Published draft guidance “M11 Template: Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
This template is designed for interventional clinical studies of medicines, vaccines, and medication/device combos that are intended for drug registration. The template is appropriate for all stages of clinical research as well as all therapeutic disciplines. Its development took into account existing ICH Guidelines and ISO 14155. The template is intended to be customizable for the specific trial. More information and norms about flexibility may be found in the sections below.
Source: m11 template: clinical electronic structured harmonised protocol (cesharp)
FDA Published draft guidance “M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
This document’s objective is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification (TS) is to be aligned with the most recent version of the ICH M11 Guideline and protocol template, but with flexibility in addressing ICH and regional authority data exchange needs.
FDA Published draft guidance “M11 Clinical Electronic Structured Harmonised Protocol”
Date of news: December 21, 2022
The clinical protocol specifies the techniques and procedures that will guide the conduct and analysis of a human clinical study of a pharmaceutical product(s). To date, no internationally recognised harmonised standard for the format and content of the clinical protocol has been created to facilitate uniformity among sponsors and the electronic interchange of protocol information.
Source: https://www.fda.gov/media/164112/download
FDA Published draft guidance “Controlled Correspondence Related to Generic Drug Development”
Date of news: December 21, 2022
This advice explains how generic medication makers and allied industries, or their representatives, can submit restricted communication to the FDA seeking generic drug development information. This guideline also covers the Agency’s procedure for communicating with recipients of such mail.
Source: Controlled Correspondence Related to Generic Drug Development
News from ICH “ICH M13 draft Guideline reaches Step 2 of the ICH process”
Date of news: December 21, 2022
The ICH M13A Guideline is part of the anticipated ICH M13 Guideline series (M13A-C) and is intended to provide recommendations on conducting bioequivalence (BE) studies for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
Source: https://database.ich.org/sites/default/files/ICH_M13A_Step2_draft_Guideline_2022_1125.pdf
News from EDQM “European Paediatric Formulary: Chloral Hydrate Oral Solution monograph open for public consultation in Pharmeuropa PaedForm”
Date of news: December 21, 2022
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has just published Issue 5 of Pharmeuropa PaedForm, in which the draught text for Chloral hydrate 100 mg/mL Oral Solution is available for public comment prior to its inclusion in the European Paediatric Formulary. The closing date for comments on the text in Pharmeuropa PaedForm is March 31, 2023. The PaedF Working Party has produced its sixth monograph.
Pharma GMP News of the Week: 18-December-2022
Period: December 11, 2022 to December 17, 2022
The European Commission takes action to streamline EMA fee regulations
Date of news: December 13, 2022
The European Medicines Agency charges fees, and the Commission is now proposing to modernise and simplify the law governing those payments. The major goal is to make sure that these fees more accurately represent the true expenses of the services completed and managed by EMA.
Companies must pay EMA a charge for the agency’s evaluation when they submit a request for a marketing authorization for a drug. The compensation that EMA gave to national authorities participating in the evaluation is also included in this price. To ensure that the fees more accurately represent the necessary expenditures, the Commission’s proposal updates the whole EMA charge structure. A cost-monitoring system and more latitude for adjusting rates in response to large changes in costs.
Source: Pharmaceuticals: Commission proposes updated EMA fees
Safety and data integrity are significant considerations in the EMA’s published recommendations for conducting decentralised trials
Date of news: December 13, 2022
Electronic diaries, wearables, phone conversations, and online appointments are just a few of the decentralised components that clinical trials for medical items have already incorporated. The agencies stated in a recommendation paper released on December 13, 2022 that the proper use of these components depends on the type of clinical trial, the trial population, the disease being treated, the trial participant’s condition, the type of medical product, as well as the product’s characteristics and stage of development.
Source: RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS
FDA Published final guidance on “Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry”
Date of news: December 14, 2022
This guideline is designed to help applicants of ANDAs submitted under section 505(j) of the Federal FD&C Act (21 U.S.C. 355(j)) reply to FDA complete response letters (CRLs). ANDA applicants are obligated by rule to take action after obtaining a CRL. The guideline updates the guidance given in July 2022 with the same title. The purpose of this change is to include the performance objectives established in the Generic Drug User Fee Amendments. Performance Goals and Program Enhancements for Fiscal Years 2023-2027. This advice includes information and suggestions on various courses of action for an ANDA application following the release of a CRL, as well as measures that the FDA may take if the applicant fails to react to the CRL.
Source: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
News from EDQM: Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)
Date of news: December 14, 2022
In the interests of global standardisation, the updated general chapter Chromatographic separation techniques (2.2.46) was included in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This updated version, which will go into effect on January 1, 2023, has several significant modifications.
The sensitivity requirement is one of these adjustments. Unlike from Ph. Eur. Supplement 6.4 through Supplement 10.8, where it is calculated on a window of at least 5 times the peak width at half height (“at least 5 x Wh”), the revised chapter instructs users to calculate the signal-to-noise (S/N) ratio on a window of 20 times the peak width at half height (“20 x Wh”).
The Ph. Eur. Commission had to examine this adjustment in light of recent data received by the European Directorate for the Quality of Medicines & Healthcare (EDQM) that suggested some of our users would find it technically difficult.
So, instead of using “20 x Wh,” Ph. Eur. users are urged to continue computing the S/N ratio on a window that is “at least 5 x Wh.”
The updated version of General Chapter 2.2.46 will be included in Supplement 11.3 (to be published in July 2023 and implemented on 1 January 2024).
FDA Published draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022)”
Date of news: December 15, 2022
A draught of a guideline document titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” is now available, according to the Food and Drug Administration (FDA or Agency). The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the FDA Reauthorization Act of 2017 (FDARA), and as a result, a device is now considered adulterated if the owner, manager, or agent of the factory, warehouse, or establishment where it is made, processed, packed, or stored delays, refuses, or restricts an FDA inspection.
The sorts of behaviours (actions, inactions, and situations) that the FDA regards to constitute delaying, denying, or restricting inspection, or refusing to authorise entrance or inspection, are described in this draught advice for both pharmaceuticals and, as of today, devices. This draught guideline is meant to replace the FDA’s final industry guidance from October 2014, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” once it has been completed. The FDA guideline from October 2014 is still in force until it is withdrawn and will continue to represent FDA’s current thinking on this matter until this draught guidance is finalised. Comments on the addition of devices to the October 2014 guidelines are of special relevance to FDA.
Source: https://www.fda.gov/media/163927/download
EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals
Date of news: December 15, 2022
The 5th version of the Guide to the Quality and Safety of Tissues and Cells for Human Application has just been released by the European Directorate for the Quality of Medicines & Healthcare (EDQM). With regard to assuring the quality and safety of human tissues and cells used on patients, the revised handbook offers a thorough review of the most current developments in the area. It is designed for medical professionals who are involved in all phases of the pertinent activities, from finding suitable donors to using it clinically on patients and monitoring their progress.
EMA published highlights of December 2022 meeting of Management Board
Date of news: December 16, 2022
Key highlights of the meeting are on the following topics;
1. The 2023 budget and EMA multiannual programming.
2. The Clinical Trials Regulation’s implementation.
3. The regulation governing veterinary medicinal products is put into effect.
4. Report of the Committee on Advanced Therapies.
5. Audit plan 2023 and audit approach 2023–2025.
Source: EMA Management Board: highlights of December 2022 meeting | European Medicines Agency
Pharma GMP News of the Week: 11-December-2022
Period: December 4, 2022 to December 10, 2022
The European Commission presents a strategy to create emergency diagnostic regulatory channels.
Date of publication: November 30, 2022
The European Commission intends to investigate and establish diagnostic regulatory channels “to provide both an adequate degree of oversight and rapid market entry in the case of an emergency.”
The Commission’s Health Emergency Preparedness and Response Authority (HERA) highlights diagnostics as critical medical countermeasures in its State of Health Preparedness Report, citing their importance in epidemiological monitoring as well as the identification of the most appropriate therapy. Diagnostics, as HERA points out, allow pathogen identification and antibiotic susceptibility testing.
Source: State of Health Preparedness Report
The EU sets implementing regulations for devices that do not have a medical function
Date of news: December 1, 2022
Under the Medical Devices Regulation, the European Union has produced implementing regulations that provide uniform requirements and rules for the reclassification of items that do not have a medical purpose (MDR).
MDR includes an appendix that specifies classes of items such as contact lenses, dermal fillers, and liposuction machines that do not have a medical function but are nevertheless regulated. The regulation is written to apply to products “taking into account the state of the art, and in particular existing harmonized standards for analogous devices with a medical purpose, based on similar technology, and states that common specifications must address risk management and, if necessary, clinical safety evaluation.
FDA published final guideline “E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials”
Date of news: December 05, 2022
The purpose of this guideline is to offer internationally unified guidance on the use of selective safety data gathering in specified pre-approval or post-approval late-stage clinical studies. Selective safety data collection refers to the collecting of limited amounts of particular types of data in a clinical study following careful analysis of the criteria that would warrant such an approach. It may be able to conduct clinical trials more efficiently by adapting the procedure and simplifying the approach to safety data gathering.
Source: https://www.fda.gov/media/163670/download
FDA published final guideline “Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer”
Date of news: December 06, 2022
This document provides recommendations for sponsors of investigational new drug (IND) and biologics licence application (BLA) submissions under 42 U.S.C. 262 and 21 CFR Parts 312 and 601 on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. Because this guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, it does not address the development of alternative dosing regimens for other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
FDA published draft guideline “Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations”
Date of news: December 06, 2022
Aluminum toxicity in parenteral nutrition (PN) is a serious safety problem, demanding that PN products fulfil the standards for aluminium content and labelling in 21 CFR 201.323. Aluminum concentration in large volume parenteral (LVP) medication products used in total parenteral nutrition (TPN) therapy shall not exceed 25 micrograms per litre (mcg/L), according to the law. The aluminium content restrictions of small volume parenteral (SVP) medication products and pharmacy bulk packages (PBPs) used in PN, on the other hand, are not set by legislation or regulation. Furthermore, the International Council for Harmonisation (ICH) has not defined a PDE for aluminium.
Source: https://www.fda.gov/media/163799/download
FDA published final guideline “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry”
Date of news: December 07, 2022
This guideline explains how we plan to prioritise enforcement and regulatory actions for homoeopathic medicine products marketed in the United States without FDA clearance. As explained further below, the FDA has devised a risk-based strategy through which the Agency plans to prioritise enforcement and regulatory actions concerning certain categories of such goods that may represent a larger risk to public health.
Source: Homeopathic Drug Products | FDA
News from MHRA “MHRA Added ‘Register of Electronic Export Certificates Issued by the MHRA (Human)”
Date of news: December 08, 2022
These documents provide information about all the electronic export certificates issued by the Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Human medicines: register of electronic export certificates – GOV.UK
FDA published draft guideline “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers”
Date of news: December 09, 2022
The FDA is issuing this draught guidance to assist manufacturers in better understanding and implementing the Voluntary Summary Malfunction Reporting (VMSR) Program, which is an established voluntary programme in which manufacturers may submit certain malfunctions related to devices with specific product codes to the FDA in a summary format on a quarterly basis. The FDA’s VMSR Program is intended to benefit both the FDA and the public by increasing transparency for the public, assisting the FDA in processing certain malfunction reports efficiently, allowing both the FDA and the public to more easily identify malfunction trends, and reducing the burden on manufacturers. The purpose of this advisory is to explain, rather than modify, the terms of the VMSR Program.
Source: https://www.fda.gov/media/163692/download
FDA published draft guideline “Content of Human Factors Information in Medical Device Marketing Submissions”
Date of news: December 09, 2022
This draught guideline paper contains the FDA’s recommendations for human factors information that should be captured and included in medical device marketing submissions where such submissions are necessary. The guidelines are meant to increase uniformity and speed up the examination of medical device applications.
Source: https://www.fda.gov/media/163694/download
EDQM published post “How CEP holders can avoid the rejection of notifications”
Date of news: December 09, 2022
CEP holders are reminded that the EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to European Pharmacopoeia Monographs lists different notifications and associated conditions, and that any change that is not classified as a notification or a major change should be classified as a minor change by default (with the exception of editorial changes for which specific guidance is given in the policy document). If the change cannot be classed as a notice by the document, a minor modification (by default) should be filed.
Members of the European Council endorse a plan to postpone MDR deadlines
Date of news: December 09, 2022
Members of the European Council voiced support for the European Commission’s proposal to postpone the transitional dates for medical devices under the Medical Devices Regulation (MDR). Members expressed concern that there is insufficient capacity to handle the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires, and they fear that if the current deadlines are not met, widespread shortages will result.
Source: https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
Pharma GMP News of the Week: 4-December-2022
Period: November 27, 2022 to December 3, 2022
In order to engage with DARWIN EU®, the Data Analysis and Real-World Interrogation Network, EMA has chosen the first group of PDF icon data partners.
Date of news: November 23, 2022
Source: DARWIN EU® welcomes first data partners | European Medicines Agency
FDA has published guidance “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies”
Date of news: November 28, 2022
The FDA examined information from stakeholders, including doctors, scientists, and patients concerned about adequate access to FMT for patients with C. difficile infection who are not responding to traditional therapy, in developing this policy. The FDA created this strategy to enable patients gain access while also addressing and managing the dangers that centralised manufacture in stool banks poses to persons receiving such goods.
This guidance supersedes the guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,” which was issued in March 2016.
FDA has published draft guidance “Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)”
Date of news: November 29, 2022
The FDA is releasing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), which was issued in 2006. With the exception of minor or editorial modifications, Edition 5 (Final Guidance) retains the questions and answers from Edition 4 (Final Guidance). Furthermore, the FDA is providing this advice, Edition 5 (Draft Guidance), to solicit feedback on the additional or updated questions and answers. It should be noted that some questions and answers from Edition 4 (Final Guidance) have been withdrawn and moved to this Edition 5 (Draft Guidance) for feedback if the FDA concluded that the question and answer needed to be altered in any way.
Source: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
A senior FDA official advocates for cloud-based regulatory reviews
Date of news: November 30, 2022
At a symposium on drug master files (DMFs) and structured data submissions on November 30, a top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving toward this platform through ongoing internal and international harmonisation initiatives.
Date of news: Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions November 30, 2022
The European Commission updates data for potential reference labs.
Date of news: November 30, 2022
The informational package for potential EU reference laboratories has been revised by the European Commission. To give applicants important information regarding the function of the laboratories and the selection procedure, officials initially released the pack in July.
FDA has published draft guidance “Statistical Approaches to Establishing Bioequivalence”
Date of news: December 2, 2022
Part 320 specifies the requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements, as well as the definitions of BA and BE and the types of in vitro and in vivo studies appropriate for measuring BA and establishing BE (21 CFR part 320). This advice includes recommendations for meeting Part 320 requirements for all drug products.
Source: https://www.fda.gov/media/163638/download
FDA has published draft guidance “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions”
Date of news: December 2, 2022
The Food and Drug Administration (FDA) is issuing this revised draught guidance to incorporate programme enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC)2 within the abbreviated new drug application (ANDA) assessment program3 agreed upon by the Agency and industry as part of the Generic Drug User Fee Amendments (GDUFA III) reauthorization, as described in GDUFA Reauthorization Performance Goals and Program E. 4 This guideline updates the proposed guidance for industry on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications issued in November 2017. (Pre-Submission Facility Correspondence).
Source: https://www.fda.gov/media/163643/download
EMA published “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November – 1 December 2022”
Date of news: December 2, 2022
India will revise its New Drugs and Clinical Trials Rules to include information on non-clinical test methods
Date of news: November 22, 2022
The Indian government has recommended revisions to the 2019 New Drugs and Clinical Trials Rules. Officials intend to revise the Act to provide more information regarding non-clinical testing procedures.
The Act now specifies that “requirements for non-clinical investigations have been stipulated in the Second Schedule.” The amended paper will include a new section on particular sorts of testing methodologies for determining the safety and efficacy of new medications.
As non-clinical testing approaches that new drug developers may use, the update cites cell-based assays, organ chips and micro physiological systems, advanced computer modelling, various human biology-based test methods, and animal research. The draught is now available for comment.
Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTI4Nw==
Pharma GMP News of the Week: 27-November-2022
Period: November 20, 2022 to November 26, 2022
News from ICH “Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022”
Date of news: November 22, 2022
The International Council for Harmonisation (ICH) Assembly convened in person on the 15th and 16th of November 2022, in Incheon, Republic of Korea, in tandem with sessions of 10 Working Groups, and was preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The meeting was an essential chance to progress the work of the ICH’s thirty-three Working Groups as well as critical initiatives such as training.
The ICH Assembly also welcomed DPM, Tunisia as a new ICH Observer, raising the total number of ICH Members and Observers to 20 and 36, respectively.
To read more about Progress on current ICH Guidelines and actions towards harmonisation, refer to the following link.
EDQM is conducting a survey to seek the input of its stakeholders to construct upcoming four-year strategy (2024-2027)
Date of news: November 23, 2022
The goal of this consultation is to solicit feedback from EDQM stakeholders (including the general public) in order to build the EDQM’s forthcoming four-year plan (2024-2027) and guarantee that it consistently satisfies their requirements and expectations while keeping up with changes in its environment.
We aim to put our stakeholders at the center of our approach. The survey’s stakeholder engagement questions are a first step in improving our relationships with them and establishing a conversation to collaboratively achieve common goals.
The input required in this poll centers on four topic modules:
1 – EDQM governance and operation, present aims and activities
2 – Prospective difficulties and opportunities
3 – Communication and stakeholder participation
4 – Your assessment of the EDQM’s appeal as a management tool.
Source: https://survey.edqm.eu/index.php?r=survey/index&sid=228868&lang=en
Pharma GMP News of the Week: 20-November-2022
Period: November 13, 2022 to November 19, 2022
The Indian government has revised the Drugs (Prices Control) Order, 2013 to reflect the publication of the National List of Essential Medicines (NLEM) 2022.
Date of news: November 2022
Indian officials announced the amended NLEM in September, eliminating 26 medications and adding 34 more to produce a list of 384 recognised items deemed necessary by the government. The list contains additional cancer medications, newer diabetic treatments, and four patent-protected drugs, and it explains the reach of Indian pricing limitations.
The amended legislation includes the NLEM drugs, as well as the level of healthcare in which they are utilised — primary, secondary, or tertiary — and the dosage form and strengths covered by the price control order. Companies that reformulate NLEM components to improve on the basic product will face various rules.
News from India, NPPA, India – In response to input from stakeholders on operational difficulties, India’s National Pharmaceutical Pricing Authority (NPPA) modified the Integrated Public Database Management System 2.0 (IPDMS).
Date of news: November 14, 2022
The NPPA met with stakeholders last month to discuss the rollout of IPDMS 2.0, the system used to gather data from pharmaceutical manufacturers online, and to get their opinions on the operational challenges the sector is now facing. The conference produced 40 problems, which the NPPA listed and addressed in a fresh report of the conversation.
Source: https://www.nppaindia.nic.in/wp-content/uploads/2022/11/IPDMS-Ver-2.pdf
Notice from MHRA on “Access Consortium Good Manufacturing Practice (GMP) Statement”
Date of news: November 15, 2022
Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition.
Source: Access Consortium Good Manufacturing Practice (GMP) Statement – GOV.UK
News from EDQM – “Polypharmacy and ageing” – EDQM participation in ESCP symposium in Prague
Date of news: November 15, 2022
The 50th European Society of Clinical Pharmacy (ESCP) Symposium, with the theme “Polypharmacy and ageing – customised, person-centered treatment,” was held in Prague from October 19 to October 21, 2022. EDQM representatives attended.
Source: https://www.edqm.eu/en/-/-polypharmacy-and-ageing-edqm-participation-in-escp-symposium-in-prague
New from MHRA “MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use”
Date of news: November 16, 2022
The MHRA has received inquiries from a number of businesses about cannabis-based medicines. This blog offers details on the authorizations needed to manufacture in this area of the pharmaceutical business, according to MHRA Manufacturing Licence Application.
Please refer to the following guideline, which was revised in March 2020, for an overview of unlicensed cannabis-based products for medical use (unlicensed CBPMs).
Update on MHRA site on “Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing”
Date of news: November 17, 2022
PIC/S published Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)
Date of news: November 17, 2022
A concept paper on the revision of Annex 11 (computerised systems) of the EU-PIC/S GMP Guide has been created by a dedicated European Medicines Agency (EMA) Drafting Group, in which PIC/S is represented by Ib Alstrup (Denmark / DKMA), who is also the Chair of the PIC/S Working Group on the revision of PI 011 (PIC/S Recommendation on Computerized Systems).
This concept paper is available for download on the PIC/S website (https://picscheme.org/en/publications?tri=date#zone) as well as the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/gmp-gdp-inspectors-working-group#concept-papers,-reflection-papers
By January 16th, 2023, comments must be submitted to ADM-GMDP@ema.europa.eu using the EMA template, which may be downloaded using the link in the Concept Paper.
Source: https://picscheme.org/docview/4967
FDA published “Cybersecurity Modernization Action Plan” on its website
Date of news: November 17, 2022
A new action plan for tackling cybersecurity has been announced by the US Food and Drug Administration (FDA), stating the agency’s aim to improve, modernise, and upgrade its defences against assets and data.
The Office of Digital Transformation (ODT) takes its duty to protect people and data in today’s climate of rising cybersecurity threats seriously. Cybersecurity is one of the FDA’s top priorities. We have created this Cybersecurity Modernization Action Plan (CMAP) in order to improve situational awareness, modernise cybersecurity capabilities, and strengthen the FDA’s ability to protect sensitive information in order to reduce overall security risks to the Agency. We are aware of the dangers that come with running a global information technology enterprise.
Source: Cybersecurity Modernization Action Plan | FDA
FDA published final guideline on “Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act”
Date of news: November 18, 2022
Regarding the production of beta-lactam oral antibiotic suspension products that are included on the FDA’s medication shortage list by a licensed pharmacist in a State-licensed pharmacy or Federal facility, this guideline outlines the FDA’s regulatory and enforcement priorities. There is a severe lack of amoxicillin oral antibiotic powder for suspension right now. Products made of the oral antibiotic amoxicillin powder for suspension are now listed as being in low supply by the FDA.
Amoxicillin is frequently used, among other things, to treat bacterial upper and lower respiratory infections in children. There is an urgent need to boost the availability of these beta-lactam oral suspension solutions as a result of this scarcity. Numerous reports on the rising demand for amoxicillin oral antibiotic suspension products in particular have been sent to FDA. Concerning the creation of compounded versions of those products from FDA-approved tablets and capsules, FDA has also received requests for clarification.
EMA published article on “European Antibiotic Awareness Day 2022: Preventing antimicrobial resistance together”
Date of news: November 18, 2022
EMA is emphasizing on criticality to raise awareness of the threat that antimicrobial resistance poses to global public health and to act immediately. To read more about it, refer to the following link.
Pharma GMP News of the Week: 13-November-2022
Period: November 6, 2022 to November 12, 2022
Europe’s contribution of worldwide drugs R&D has shrunk by a fourth in the last two decades, as the sector’s decreasing patterns continue.
Date of news: November 7, 2022
Europeans are losing access to new medications and the chance to participate in groundbreaking clinical trials as research and development of new therapies shifts to more ambitious life science industries in the United States and Asia.
A new research for EFPIA published today by Charles River Associates offers a troubling picture of Europe’s declining competitiveness, with the worldwide share of pharmaceutical R&D expenditure, clinical trials, and manufacturing output all shrinking. The problem is particularly serious for Advanced Treatments Medicinal Products (ATMPs), which are tissue, gene, and cell therapies intended to prevent, treat, and cure uncommon illnesses such as certain cancers, and where the US and China dominate.
The Indian Pharmacopoeia Commission provides clarification on the application of new general chapters.
Date of news: November 7, 2022
In response to stakeholder issues concerning implementation and compliance, the Indian Pharmacopoeia Commission (IPC) defined the obligations imposed by three new general chapters.
The Indian Pharmacopoeia’s ninth edition, published in July, included chapters on dosage unit homogeneity, elemental contaminants, and nitrosamine impurities. The announcement issued last week describes how the three new general chapters would affect pharma producers.
The consistency of dosage units chapter was developed by IPC for “information and awareness,” but it is not cited in individual monographs, thus adoption remains voluntary. Adoption of the elemental impurities chapter is also optional, while IPC adds that it will gradually replace the heavy metals test in individual monographs to make it mandatory in the 2026 edition.
The monographs for sartan active medicinal components refer to the third chapter on nitrosamine impurities. IPC expects other medication producers to follow the general guidelines and test for nitrosamine contaminants wherever “suitable and required.”
Source: IPC’s Notice Regarding General Chapters of IP 2022 – Indian Pharmacopoeia Commission
FDA published draft guideline on “Sameness Evaluations in an ANDA – Active Ingredients”
Date of news: November 8, 2022
The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating similarity between the active ingredient in a proposed generic drug product and its reference listed drug (RLD), as required by section 505(j)(2)(A)(ii) of the FD&C Act and FDA regulations of § 314.94(a)(5) (21 CFR 314.94(a)(5)).
Source: Sameness Evaluations in an ANDA — Active Ingredients
MHRA updated guideline “Clinical trials for medicines: manage your authorisation, report safety issues”
Date of news: November 8, 2022
MHRA Return to International GMP Inspections
Date of news: November 8, 2022
The MHRA Inspectorate made a blog post in March 2020 in which MHRA declared that they will only perform on-site inspections related to the UK Government’s COVID-19 response or any other potential major public health risk until further notice. MHRA provided an update in July 2020 outlining our plans to resume a full programme of UK on-site inspections in October 2020. MHRA was unable to plan for a return to international inspections at the moment, but we promised to give more information as the situation progressed.
Source: Return to International GMP Inspections – MHRA Inspectorate
FDA published draft guideline on “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin”
Date of news: November 11, 2022
The guideline explains what data should be given in marketing application and registration packages for biotechnology goods, as well as what data should be tested and evaluated for viral safety. Biotechnology products include biotherapeutics and various biological products developed from cell cultures established from human or animal cell banks (e.g., mammalian, avian, insect). The term “virus” in this article excludes non-conventional transmissible agents such as those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are recommended to consult with the appropriate regulatory authorities about issues related to bovine spongiform encephalopathy.
FDA published final guideline on “Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents”
Date of news: November 14, 2022
This guideline is being issued by FDA to clarify our approach to referring to the terms “device” and “counterfeit device” in FDA publications. For many years, the concept of “device” has been established in FD&C Act section 201(h). The definition of device was renamed to section 201(h)(1) of the FD&C Act upon the passage of the Safeguarding Therapeutics Act in January 2021, and the new term “counterfeit device” and its meaning were designated at section 201(h)(2) of the FD&C Act. The FDA is publishing this guideline to clarify how we plan to refer to the terms “device” and “counterfeit device” in guidance, regulatory papers, communications, and other public publications, as well as how we expect to interpret current references to section 201(h) of the FD&C Act.
Pharma GMP News of the Week: 6-November-2022
Period: October 30, 2022 to November 5, 2022
The Medical Device Coordination Group (MDCG) has issued guidelines on authorised representatives’ roles and responsibilities under the new medtech rules.
Date of news: October 31, 2022
MDCG unpacks the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for authorised representatives, manufacturers, and other economic operators in the guidelines.
Manufacturers without a presence in a member state are required by EU legislation to select a solitary authorised representative who serves as their EU contact person and is critical to maintaining compliance. MDR and IVDR define authorised representatives’ obligations and expand their responsibilities.
FDA published draft guideline on “Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability”
Date of news: October 31, 2022
This guidance is designed to help sponsors track growth and, where necessary, pubertal development in paediatric study participants with both uncommon and common disorders. This guideline offers suggestions for the best ways to gauge pubertal development and measure and record growth in order to assess safety.
Source: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
FDA published final guideline on “Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide”
Date of news: November 1, 2022
This guideline was created by the FDA in compliance with Section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). It aims to aid small entity businesses that produce human cells, tissues, or cellular or tissue-based products (HCT/Ps) in understanding the thorough regulatory framework for HCT/Ps that is outlined in Title 21 of the Code of Federal Regulations, part 1271. (21 CFR 1271). Important terminology used in 21 CFR 1271 are defined in section 21 CFR 1271.3.
FDA published draft guideline on “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers”
Date of news: November 1, 2022
In order to comply with FDA regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which took effect on October 13, 2009, this guidance provides information for business, researchers, physicians, institutional review boards (IRBs), and patients. Regarding the execution of the legal requirements for wider access, FDA got a lot of inquiries.
Source: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
FDA published draft guideline on “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program”
Date of news: November 1, 2022
In accordance with sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which were added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), the Food and Drug Administration (FDA) is authorised to charge and collect user fees from qualified manufacturers of OTC monograph drugs and requestors of OTC monograph order requests, other than OMORs fo The several OMUFA fee kinds, payment deadlines, and fee exclusions are all included in this guideline. Additionally, this advice outlines the FDA fee submission procedure, the penalties for not paying the requisite fees, and the refund submission procedure.
Source: https://www.fda.gov/media/162759/download
FDA published final guideline on “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals”
Date of news: November 2, 2022
All medications that must undergo carcinogenicity testing in accordance with ICH S1A are covered by this Addendum. Refer to the ICH industry guidance S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012) for information on pharmaceuticals derived from biotechnology.
Source: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals | FDA
FDA published final guideline on “Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry”
Date of news: November 2, 2022
Oncology medication approvals frequently enhance the therapeutic effectiveness of existing regimens by include new pharmaceuticals or by merging experimental medicinal products to form a combination regimen, resulting in new regimens with higher efficacy. Historically, applicants have not asked for modifications to a drug’s labelling to explain how to take it in a different regimen (cross labeling). Cross labelling for cancer medication combination regimens has, however, been recommended in an increasing number of recent applications. This advice outlines the FDA’s current recommendations for adding pertinent information in the labelling for cancer treatments approved for use in a combination regimen, as well as significant factors for the cross-labeling of these medications.
Source: Cross Labeling Oncology Drugs in Combination Regimens
News from EMA: By the end of November, EMA invites businesses to submit type I variations for 2022.
Date of news: November 3, 2022
Marketing authorization holders are encouraged by the European Medicines Agency (EMA) to submit type IA and type IAIN variations for 2022 by no later than Wednesday, November 30, 2022. This will allow EMA to validate the submissions within the 30-day window specified in Article 14 of Commission Regulation (EC) No 1234/2008 and prior to the Agency’s closure between December 23, 2022, and January 3, 2023.
FDA published final guideline on “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
Date of news: November 4, 2022
This guideline is intended to offer suggestions to sponsors looking to test several iterations of a cellular or gene therapy product in an early-phase clinical trial for a particular condition. In a single clinical study, sponsors have indicated interest in obtaining preliminary proof of the efficacy and safety of several iterations of a cellular or gene therapy product. Although several product versions can be tested simultaneously in a clinical study, each product version is unique and is typically submitted to the FDA in a separate investigational new drug application (IND). These early-phase clinical trials are intended to provide guidance on which product version or versions to pursue for additional development in later-phase investigations.
FDA published final guideline on “M10 Bioanalytical Method Validation and Study Sample Analysis”
Date of news: November 4, 2022
The guidelines include the procedures and processes that should be characterised for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. They also include recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions. The purpose of the advice is to give the industry unified regulatory standards for the validation of bioanalytical methods employed in assays used to support regulatory submissions. The guideline takes the place of the June 27, 2019, draught draft advice titled “M10 Bioanalytical Method Validation.
Pharma GMP News of the Week: 30-October-2022
Period: October 23, 2022 to October 29, 2022
European Commission (EC) Decision Reliance Procedure updated email address from IPUenquiries@mhra.gov.uk to RIS.NA@mhra.gov.uk for enquiries on submitting applications for orphan designations.
Date of news: October 24, 2022
Source: European Commission (EC) Decision Reliance Procedure – GOV.UK
The UK postpones the new Medical Device Regulations by a year.
Date of news: October 25, 2022
The UK government has decided to take a stance that “supports system preparedness and reduces the risk of supply interruptions” by delaying the introduction of the future medical device regulations. The revised regulation’s intended implementation date is now July 2024.
In order to minimise the potential of disruption, the government justified the postponement by saying that it would “ensure that there is a reasonable approach to its implementation.” The usage of an EU-compliant approval procedure was recently extended by 12 months by the Medicines and Healthcare Products Regulatory Agency (MHRA).
ICH published Introductory Training Presentation on E19 on its website
Date of news: October 25, 2022
This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process.
This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake.
Source: https://database.ich.org/sites/default/files/ICH_E19_Step_4_Presentation_2022_1012.pdf
FDA published final guidance on “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions”
Date of news: October 26, 2022
The purpose of this guidance document is to assist Food and Drug Administration (FDA) staff in formulating a request for further information in compliance with the Least Burdensome Provisions of the FD&C Act in order to reach a judgement regarding a medical device marketing application. A “deficiency” is the term for such an FDA request for additional information. In order to make the best use of both industry and FDA’s time, this advice also offers suggested formats for FDA personnel to utilise when communicating shortcomings and for industry to use when responding to such requests.
For the purpose of facilitating a productive review process, this guidance contains illustrations of well-constructed flaws and industry answers. Additionally included in this guidance are supervisory review, major/minor problems, additional factors, and the order in which deficiencies should be addressed in FDA deficiency letters.
FDA published draft guidance on “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention”
Date of news: October 27, 2022
The Food and Drug Administration has made a proposed guidance for industry titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” availabl. The goal of this proposed guideline is to aid sponsors in the clinical development of medications for the treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI).
MHRA has updated guideline on Guidance on pharmacovigilance procedures
Date of news: October 28, 2022
The Pharmacovigilance Procedures guideline has been amended to incorporate more information on MHRA submission requirements, particularly for signals, Risk Management Plans (RMPs), and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been amended with additional requirements for PSUR filing for Northern Ireland-approved items. Additional sections on MHRA Safety Reviews and Safety Communications have been added.
Pharma GMP News of the Week: 23-October-2022
Period: October 16, 2022 to October 22, 2022
MHRA has revamped Software and AI as a Medical Device Change Programme
Date of news: October 17, 2022
Software (and AI in particular) has a wide range of uses in both health and social care, and it is becoming more and more prevalent in health systems. Many of these applications will fall within the purview of medical devices regulation. In order to ensure that patients, the general public, and healthcare professionals have access to the most advanced medical technology, it is becoming more and more crucial that medical device regulation be effective.
This work plan will bring about radical change to create a regulatory framework that offers a high level of patient and public protection while also ensuring that the UK is the hub of responsible innovation for medical device software.
Source: Software and AI as a Medical Device Change Programme – GOV.UK
In revised CPGs, the FDA addresses alternate inspection instruments and requirements for nitrosamine evaluations
Date of news: October 17, 2022
The FDA has revised two compliance programme guidelines (CPGs) that cover pre-approval inspections (PAIs) and routine good manufacturing practise (GMP) monitoring inspections.
The updates reflect the FDA’s use of alternative tools for evaluating facilities in lieu of onsite inspections, which were heavily used during the pandemic, as well as newly added sections covering nitrosamine risk assessments and the incorporation of International Council for Harmonization (ICH) guidelines. Both CPGs took effect on October 17.
Source:
Compliance program 7346.832 Preapproval Inspections
Compliance program 7356.002 Drug Manufacturing Inspections
EMA has published Staff Working Document on Vulnerabilities of the global supply chains of medicines: Structured Dialogue on the security of medicines supply
Date of news: October 17, 2022
This Staff Working Document summarises the main findings of the stakeholders’ work on pharmaceutical supply chain challenges in general, as well as presenting the draught methodology for identifying Critical Medicines and, once identified, approaches that could be used to identify vulnerabilities in the supply chain of those medicines to improve supply security.
The study also considers the issues that may be connected with specific vulnerabilities, such as dependence in a highly globalised pharmaceutical business, the regulatory environment, and the green and digital transitions. The Structured Dialogue has increased communication and information exchange among stakeholders in the supply chain.
Regarding chemical applications for polymorphs, EDQM modifies CEP policy
Date of news: October 18, 2022
The EDQM has changed its stance on polymorph chemical uses. A request for a Certificate of Suitability to European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now available even if the sentence “the substance demonstrates polymorphism” is not specified in the EP’s relevant individual monograph’s “Characters” section.
In such circumstances, the applicant should include data from the literature or any other suitable proof to indicate that the material exhibits polymorphism. The substance specification should contain an analytical technique adequate for characterising the proposed polymorphic form. If the request is granted, the CEP will be updated with a subtitle for the specific polymorph, as well as the technique used to characterise it.
FDA Published draft guideline on “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care”
Date of news: October 21, 2022
This draft guideline was created by the FDA to recommend specific revisions to the FDA guidance paper “Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff.”
This guidance proposes specific updates to the guidance that clarify how the programme may apply to certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The current Breakthrough Devices Program guidelines will continue in force until this draught guidance is approved.
FDA Published final guideline on “Human Gene Therapy for Neurodegenerative Diseases”
Date of news: October 21, 2022
This advice gives recommendations to sponsors developing human gene therapy (GT) products for adult and paediatric patients suffering from neurodegenerative disorders. Neurodegenerative diseases are a diverse set of conditions defined by gradual deterioration of the central nervous system or peripheral nervous system structure and function. The genesis, frequency, diagnosis, and therapy of these diseases vary, and they include both hereditary and age-related disorders. This document focuses on product development, preclinical testing, and clinical trial design. This guideline finalises the January 2021 draft guidance of the same title.
Source: Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry
FDA Published draft guideline on “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs”
Date of news: October 21, 2022
This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, referred to as 19 topical products. Topical 21 goods (other than topical solutions) are categorised as complex products due to the complicated mode of administration associated with these products, 20 which are often locally active, and the possible complexity of some formulations.
Source: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
FDA Published draft guideline on “In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs”
Date of news: October 21, 2022
The purpose of this advice is to assist applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as topical products. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains suggestions for in vitro release test (IVRT) studies that may be used to compare a proposed generic (test) topical product to its reference standard (RS) in order to support a demonstration of bioequivalence (BE) to the reference listed medicine (RLD). The RLD is typically used as the reference standard.
FDA Published draft guideline on “In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs”
Date of news: October 21, 2022
This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as “topical products” in this document. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains recommendations for in vitro permeation test (IVPT) studies that compare a proposed generic (test) topical product to its reference standard (RS) in order to provide a demonstration of bioequivalence (BE) to the reference listed drug (RLD). The RLD is typically used as the reference standard.
Source: Draft Guidance: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
FDA Published final guideline on “Multiple Endpoints in Clinical Trials Guidance for Industry”
Date of news: October 21, 2022
This guidance provides sponsors and review staff with the Agency’s thinking on the problems posed by multiple endpoints in the analysis and interpretation of study results, as well as how to manage these problems in clinical trials for human drugs, including drugs subject to licencing as biological products. Most clinical trials in drug development have numerous endpoints to assess the treatment’s effects and demonstrate the drug’s capacity to improve one or more disease features. As the number of endpoints studied in a single trial rises, the risk of reaching incorrect conclusions regarding a drug’s effects on one or more of those endpoints increases if sufficient multiplicity adjustment is not made.
The goal of this guideline is to present several techniques for grouping and ranking endpoints for analysis, as well as to use certain well-known statistical approaches for controlling multiplicity inside a research, in order to reduce the possibility of reaching incorrect conclusions regarding a drug’s effects. Based on an investigation where the danger of incorrect findings has not been adequately addressed, a result can lead to inaccurate or misleading claims about a drug’s effects.
Source: https://www.fda.gov/media/162416/download
The proposed ICH M11 guideline has reached Step 2 of the ICH process
Date of news: October 21, 2022
A comprehensive clinical protocol organisation with standardised content is proposed by this new guideline, along with: a Template outlining the protocol’s format and structure, including its table of contents, common headers, and contents; and a Technical Specification outlining the conformance, cardinality, and other technical characteristics that permit the interoperable electronic exchange of protocol content.
Source: https://www.ich.org/page/multidisciplinary-guidelines
To comment on proposed monographs published in Pharmeuropa 34.4, CEP holders are invited.
Date of news: October 21, 2022
The list of substances for which draught updated monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.4 is a useful resource for those who have Certificates of Suitability to the European Pharmacopoeia (CEPs) monographs. The compounds that are impacted by these changes and for which a CEP has been granted are listed in the table below.
Users are advised to sign up on the European Directorate for the Quality of Medicines & Healthcare (EDQM) website for free (Pharmeuropa, Pharmeuropa Bio & Scientific Notes) in order to have access to Pharmeuropa.
The CDSCO of India allocates oncology medical devices to risk groups under MDR in 2017.
Month of news: October 2022
CDSCO has given risk categories to 48 oncology medical devices. CDSCO has classified two medical devices in its highest risk category, D. An alternating electric field antimitotic cancer treatment system and a coronary artery brachytherapy system applicator are the devices.
The remaining devices are distributed throughout the other three categories, with class C accounting for more than half of the total. Cryosurgical sets and capsular tension rings are examples of class C equipment.
In addition, the regulatory body produced a list of risk categories for 95 oral medical equipment. The majority of dental devices are low risk, prompting CDSCO to classify them as A and B, however there are exceptions.
Pharma GMP News of the Week: 16-October-2022
Period: October 9, 2022 to October 15, 2022
News from EMA – In the EU, the EMA and the HMA are moving ahead with plans to extend access and improve the quality of data used to inform decisions on the benefits and hazards of medicines
Date of news: October 10, 2022
The EMA-HMA Big Data Steering Group has endorsed two documents for public consultation, one looking at the quality of all data types used in regulatory decision-making and the other concentrating primarily on the discoverability of real-world data.
Data quality is essential for realising the full potential of data-driven regulation and fostering patient and healthcare professional confidence. The proposed Data Quality Framework for EU Medicine Regulation, which is now available for public comment, establishes quality criteria for data used in medicine regulation to ensure they are fit for purpose to support benefit-risk determinations.
Source: High-quality data to empower data-driven medicines regulation in the European Union
The EMA published a data quality framework in order to get stakeholders on the same page when it comes to data quality
Date of news: October 10, 2022
This framework covers broad data quality concerns essential for regulatory decision making, definitions for data dimensions and sub-dimensions, as well as characterization and associated metrics. It examines which data quality actions and metrics may be implemented in various circumstances and proposes a maturity model to guide the growth of automation to assist data-driven regulatory decision making.
Source: Data Quality Framework for EU medicines regulation
News from EDQM – Pharmeuropa 34.4 just released
Date of news: October 11, 2022
Pharmeuropa publishes all updated European Pharmacopoeia (Ph. Eur.) texts as well as texts that have undergone technical adjustments for public review. The Pharmeuropa 34.4 consultation period will end on December 31, 2022.
Source: Pharmeuropa 34.4 just released – European Directorate for the Quality of Medicines & HealthCare
European Medicines Agency published guideline on practical guidance on the application form for centralised type IA and IB variations
Date of news: October 11, 2022
The guideline document should be read in conjunction with the EMA/CMDh Explanatory Notes on Variation Application Form (CMDh/EMA/133/2010) to help with the preparation of the application form for type IA and IB variations to be submitted in the Centralised Procedure.
News from ICH – The ICH process has moved to Step 2 with the proposed Q5A(R2) guideline
Date of news: October 11, 2022
The R2 revision preserves core ideas from the original Guideline while also making new suggestions on recognised and complementary techniques to preventing virus contamination of biotechnology products.
The Q5A(R2) EWG created a Step 2 Informational Presentation to summarise the substance of the proposed Guideline.
Source: https://database.ich.org/sites/default/files/ICH%20Q5A%28R2%29_Step2_Presentation_2022_1005.pdf
EDQM has added Comparision of Chromatographic separation techniques: given in Ph. Eur. 10th and 11th Editions in its Knowledge database
Date of news: October 13, 2022
Source: https://extranet.edqm.eu/4DLink1/pdfs/addon/20246.pdf
News from MHRA – To enhance the safety of medicines and medical devices, the MHRA is evaluating its approach to engaging with healthcare professionals
Date of news: October 13, 2022
According to the MHRA, you can engage in this consultation anonymously, but if you enter your email address, we will add you to our mailing list to provide you with future opportunity to learn about or participate in our work.
News from MHRA – Healthcare workers and their professional organisations have a unique opportunity to offer their perspectives and impact the MHRA’s safety communication and reporting systems.
Date of news: October 13, 2022
U.S. FDA published final guidance on “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”
Date of news: October 13, 2022
The purpose of this final guidance is to assist original applicants and holders of approved NDAs, ANDAs, and BLAs in implementing chemistry, manufacturing, and controls (CMC) postapproval change using a comparability protocol (CP).
A CP is a comprehensive, prospectively written plan for evaluating the impact of proposed postapproval CMC changes on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product). These factors may relate to the product’s safety or effectiveness (i.e., product quality).
U.S. FDA published final guidance on “ANDA Submissions – Prior Approval Supplements Under GDUFA”
Date of news: October 14, 2022
This guidance is intended to help applicants who are prepared to submit to FDA prior approval supplements (PASs) and changes to PASs for ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
The guidance describes how the GDUFA affects PAS submissions. The guidance updates previous recommendations given in October 2017.
This revision is being issued to incorporate the performance goals that FDA has agreed to meet in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years [Fiscal Years [FYs]] 2023-2027 (GDUFA III commitment letter). It also clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the performance goals in the GDUFA III commitment letter.
Source: Guidance for Industry-ANDA Submissions Prior Approval Supplements Under GDUFA
News from TGA – After the European Medicines Agency has extended the validity of GMP certificates until the end of 2023, TGA guided on the pathway and have created additional options for Australian Sponsors to maintain their GMP Clearance validity.
Month of news: October 2022
The TGA has developed three possibilities for Australian sponsors to preserve the validity of their GMP approval.
- The most recent proof is less than three years old.
- The most recent evidence is more than three years old, and you have not filed a renewal application that has been evaluated using our risk-based methodology.
- The risk-based methodology was used to evaluate your current apps.
Source: GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic | Therapeutic Goods Administration (TGA)
Pharma GMP News of the Week: 9-October-2022
Period: October 2, 2022 to October 8, 2022
The Central Drugs Standard Control Organization (CDSCO) of India has extended the deadline for obtaining the necessary permits for select medical device importers and manufacturers.
Date of news: October 1, 2022
The new medical device licencing framework for Class A and B goods was put into effect by CDSCO on October 1. However, the agency received requests to postpone the deadline from stakeholders and industry associations prior to the implementation date in order to prevent a disruption in the supply of goods. Manufacturers and exporters of Class A and B devices would have needed product permits if the law had been applied.
FDA published final guideline “FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals”
Date of news: October 3, 2022
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), allowing FDA to charge user fees for the review of specific premarket submissions received on or after October 1, 2022, such as premarket notification submissions (510(k)s). In order to accomplish certain performance objectives and make changes for the medical device review process, the FDA will be allowed to use the additional revenues received through user fees, in conjunction with the industry.
FDA published draft guideline “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA”
Date of news: October 3, 2022
Owners of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be cited in an abbreviated new drug application (ANDA) or a prior approval supplement to an ANDA are the target audience for this guidance. The “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027” document outlines how FDA would implement a programme improvement that was agreed upon by the Agency and industry as part of discussions to reauthorize the Generic Drug User Fee Amendments (GDUFA) (GDUFA III commitment letter).
This advice explains the circumstances under which a DMF holder might ask for an early assessment, or “DMF prior assessment,” and the conditions under which the FDA would start an early examination of Type II API DMFs 6 months before an ANDA or PAS filing mentioning the DMF. Additionally, it offers suggestions for these DMF holders when submitting a request.
Source: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
FDA published draft guideline “Facility Readiness: Goal Date Decisions Under GDUFA”
Date of news: October 3, 2022
In accordance with section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), this guideline explains how FDA intends to set a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as a part of an original abbreviated new drug application (ANDA). The “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027” document outlines how FDA would implement a program improvement that was agreed upon by the Agency and industry as part of discussions to reauthorize the Generic Drug User Fee Amendments (GDUFA) (GDUFA III commitment letter).
Source: Facility Readiness: Goal Date Decisions Under GDUFA
FDA published final guideline “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules”
Date of news: October 3, 2022
In comparison to other dosage forms, tablets and capsules are often produced, prescribed, and may offer a variety of benefits such as the convenience of storage, portability, ease of administration, and accuracy in dosing. This guideline explains the requirement for Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.
Source: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
News from ICH “ICH E19 Guideline reaches Step 4 of the ICH Process”
Date of news: October 4, 2022
On September 27, 2022, the ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reaches Step 4 of the ICH Process.
This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process. This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake.
More information is available on the ICH E19 website.
Source: https://www.ich.org/news/ich-e19-guideline-reaches-step-4-ich-process
News from EDQM “Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders”
Date of news: October 4, 2022
The European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available. Holders of Certificates of Suitability to the Ph. Eur. Monographs (CEPs) are requested to amend their applications in accordance with the new monographs, which will be implemented on April 1, 2023.
FDA published final guideline “Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments”
Date of news: October 5, 2022
In accordance with the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027, this guidance describes how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the evaluation of an initial abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (GDUFA III commitment letter). A supplement or a modification to a supplement are not covered by this advice.
Source: Guidance for Industry | Information Requests and Discipline Review Letters under GDUFA
FDA published final guideline “Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry”
Date of news: October 5, 2022
The Federal Food, Drug, and Cosmetic Act’s section 505(j) (21 U.S.C. 355(j)) allows for the submission of abbreviated new drug applications (ANDAs), and this guidance offers recommendations to the industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between the FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA. This guidance’s processes are meant to assist ensure that post-CRL clarification teleconferences are well-managed and that they are planned and held within the time constraints specified in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027. (GDUFA III commitment letter).
The guideline in this document updates the guidance from December 2018 titled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA. This amendment outlines how FDA will conduct post-CRL clarification teleconferences pursuant to the GDUFA performance objectives and incorporates the performance goals stated in the GDUFA III commitment letter that FDA has pledged to satisfy.
FDA published final guideline “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry”
Date of news: October 5, 2022
This guideline defines an expanded pathway for talks between FDA and a prospective applicant who is planning to submit an abbreviated new drug application (ANDA) to FDA or an applicant who has already filed an ANDA for a complicated product under this guidance. This advice offers details on requesting and holding meetings with FDA for product development, pre-submission, mid-cycle review, enhanced mid-cycle review, and post-complete response letter scientific meetings.
This guideline updates the same-titled guidance that was released in November 2020. This revision is being made to reflect information on the types of complex product meetings and performance objectives specified in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027 (GDUFA III commitment letter), as well as details on how to request these meetings and the FDA’s methods for handling them.
FDA published final guideline “Competitive Generic Therapies”
Date of news: October 5, 2022
The FDA Reauthorization Act of 2017, or FDARA, established a procedure whereby the FDA may designate a medicine with “inadequate generic competition” as a competitive generic treatment upon the applicant’s request (CGT). A CGT medication’s abbreviated new drug application (ANDA) development and review may also be sped up by FDA at the applicant’s request.
The FDA Reauthorization Act of 2017, or FDARA, established a process by which the FDA may, at the request of the applicant, designate a medicine with “inadequate generic competition” as a competitive generic treatment (CGT). The FDA may also accelerate the creation and processing of an abbreviated new drug application (ANDA) for a CGT medication at the applicant’s request.
Source: Guidance for Industry: Competitive Generic Therapies
News from EDQM “Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia”
Date of news: October 5, 2022
Chemometric techniques applied to analytical data (5.21), the updated general chapter, has just been published in Supplement 11.1 of the European Pharmacopoeia (Ph. Eur.). The Ph. Eur. Commission accepted the draught during its 172nd Session in March 2022.
Numerous portions of the chapter have been fully rewritten or revised in light of recent events, and new sections/sub-sections have been added. This general revision contains the following:
(1) a revision to Section 1. A review of the sub-sections on Pre-processing (1-2-2-6) and Assessment and validation of chemometric techniques (1-3);
(2) two new sections on Independent component analysis (2-2) and Decision trees and random forests (2-6);
(3) an overview of the sections on Similarity measures (2-3), Clustering (2-5), Multiple linear regression (2-8), Principal component regression (2-9), Support vector machines for supervised classification (2-11), and Artificial neural networks (2-12);
(4) a new section, 3. Related application domains, with subsections on Chemometrics in chemical imaging (3-1) and Data fusion (3-2);
(5) an update of the Abbreviations and Glossary.
MHRA updates its guidance “Medical devices: guidance for manufacturers on vigilance”
Date of news: October 6, 2022
MHRA updated its guidance with respect to the information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Source: Medical devices: guidance for manufacturers on vigilance – GOV.UK
Pharma GMP News of the Week: 2-October-2022
Period: September 25, 2022 to October 1, 2022
India publishes proposed regulations for registering Class A medical devices that are neither sterile or measuring
Date of news: September 20, 2022
The draught revisions to the medical device rules have been made available for comment by the Indian Ministry of Health and Family Welfare. A new section on the registration of “Class A (non-sterile and/or non-measuring) medical equipment” is anticipated by officials.
Manufacturers of medical devices covered by the new chapter are required by regulations to register their goods by submitting data to an internet site. The initial plan outlines the specifics of each gadget, such as its intended usage, that makers and importers will need to input.
FDA published draft guidance on “Ethical Considerations for Clinical Investigations of Medical Products Involving Children”
Date of news: September 26, 2022
Clinical studies in children are critical for gaining data on the safety and effectiveness of medications, biological products, and medical devices in children, as well as protecting children from the dangers associated with exposure to potentially hazardous or ineffective medical goods. Children are a vulnerable demographic that cannot agree for themselves and hence require additional measures while participating in a clinical trial. Such precautions are a must for the start and continuation of paediatric research as part of a medical product development programme. The FDA’s current thinking on ethical issues for clinical trials of medicinal goods in children is described in this advice.
Source: https://www.fda.gov/media/161740/download
FDA published draft guidance on “Providing Over-the-Counter Monograph Submissions in Electronic Format”
Date of news: September 27, 2022
The Food and Drug Administration (FDA or Agency) has made a draft advice for industry titled “Providing Over-the-Counter Monograph Submissions in Electronic Format” available. This advice explains how to submit electronic submissions to the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Source: https://www.fda.gov/media/161822/download
MHRA has updated Good clinical practice for clinical trials
Date of news: September 27, 2022
FDA published final guidance on “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions”
Date of news: September 28, 2022
The FDA’s guidelines on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiography pictures and radiology device data are provided in this guidance paper. This recommendation applies to CADe devices, including the detection aspect of combined computer-aided detection and diagnostic equipment. The guidelines are meant to increase uniformity and speed up the consideration of clinical performance assessments in CADe 510(k) applications.
Source: https://www.fda.gov/media/77642/download
FDA published final guidance on “Clinical Decision Support Software”
Date of news: September 28, 2022
The final advice underscores that the FDA’s existing digital health standards continue to apply to software functionalities that fit the definition of a device, including those used by patients or caregivers. The final guidance also includes examples of how the FDA implements the Non-Device CDS criterion. These examples distinguish between Non-Device CDS functions that satisfy all four requirements and device functions that do not satisfy one or more of the criteria.
Source: https://www.fda.gov/media/109618/download
FDA published final guidance on “Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions”
Date of news: September 28, 2022
This document contains the FDA’s guidelines for premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices used on radiological pictures and radiography device data. This advise applies to all CADe devices, including those sold as a full package with a review workstation, as add-on software incorporated into imaging equipment, as an image review platform, or as other imaging accessory equipment. The guidelines are designed to encourage uniformity and make 510(k) submissions for CADe devices more efficient.
Source: https://www.fda.gov/media/77635/download
FDA published final guidance on “Display Devices for Diagnostic Radiology”
Date of news: September 28, 2022
This paper contains the FDA’s recommendations for premarket notification (510(k)) submissions for display devices used in diagnostic radiology. This advise relates to diagnostic radiological display devices as defined by their categorization rule (21 CFR 892.2050) and product numbers. This covers diagnostic radiological display equipment such as soft-copy displays and medical grade monitors. The suggestions are meant to encourage uniformity and make it easier to examine display devices.
Source: https://www.fda.gov/media/95527/download
FDA published final guidance on “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices”
Date of news: September 28, 2022
Following the issue of the final rule, “Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act,” this guideline was altered through a minor modification to reflect amended medical device classification regulations (86 FR 20278).
Source: https://www.fda.gov/media/88572/download
FDA published final guidance on “Policy for Device Software Functions and Mobile Medical Applications”
Date of news: September 28, 2022
This guideline was changed with a minor modification to accommodate amended medical device categorization requirements as a result of the final rule, “abcMedical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278), as well as to update information impacted by the final guidance, “Clinical Decision Support Software.”
Source: https://www.fda.gov/media/80958/download
The MHRA has appointed the first new UK Approved Body to certify medical devices since Brexit.
Date of news: September 29, 2022
In order to guarantee that only safe and effective medical devices are distributed to UK consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has certified that DEKRA Certification UK Ltd. has now joined the three other UK Approved Bodies.
Any possible organisation must now go through the new designation procedure in order to be permitted to certify medical devices in the UK, and DEKRA has become the first organisation to do it. They are now recognised as an organisation authorised by the UK to conduct evaluations of general medical equipment (known as Part II designation).
DG SANTE of the European Commission joins the list of PIC/S Associated Partner Organizations
Date of news: September 29, 2022
Geneva, September 29, 2022 The Directorate-General for Health and Food Safety of the European Commission has been given the status of Associated Partner Organization by the PIC/S Committee (DG SANTE).
Source: https://picscheme.org/en/news
News from MHRA – The European Commission Decision Reliance Procedure (ECDRP) is still in effect till December 31, 2023.
Date of news: September 30, 2022
To ensure that British citizens continue to have prompt access to medications while MHRA develops recommendations for a new international reliance framework, the European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023.
Source: https://www.gov.uk/government/news/european-commission-decision-reliance-procedure-ec-drp-extension
News from EMA – Fees for pharmacovigilance applications that will be adjusted as of October 3, 2022
Date of news: September 30, 2022
As on October 3, 2022, the pharmacovigilance costs that applicants and holders of marketing authorizations must pay to the European Medicines Agency will increase by 5.6% to account for inflation rate increases of 0.3% in 2020 and 5.3% in 2021.
All applications will be assessed the existing fee and reduction rates if they are submitted by or have a data lock point (DLP) of October 3, 2022. After that date, the revised charges will be applied to any applications or DLPs.
Pharma GMP News of the Week: 25-September-2022
Period: September 18, 2022 to September 24, 2022
PIC/S website published “list of PIC/S Participating Authorities”, 1 October 2022
Date of news: September 2022
Source: https://picscheme.org/docview/4753
Revised Annex 1 (Manufacture of sterile medicinal products) to guide to good manufacturing practice for medicinal products is published on PIC/S website
Date of news: September 9, 2022
With the exception of point 8.123, which is delayed until 25 August 2024, the amended Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will come into effect on 25 August 2023. The date of implementation corresponds to that of the updated EU Annex 1, which is the same as PIC/S Annex 1. (with some very minor editorial differences).
A lengthy revision process that was jointly led by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close collaboration with the European Commission (EC) and the World Health Organization comes to an end with the entrance into force (WHO). The EC, EMA, WHO, and PIC/S have worked together in a way that is best in its class.
Source: https://picscheme.org/docview/4737
India updated its National List of Essential Medicines
Date of news: September 13, 2022
The Union Health Ministry added 34 new drugs and removed 26 from the National List of Essential Medicines (NLEM) list released on Tuesday, according to Union Health Minister Mansukh Mandaviya.
The National Lists of Essential Medicines (NLEM) 2022 include 384 medicines in total. The list now includes 34 new medications, whereas 26 from the prior list have been removed. These drugs have been classified into 27 therapeutic groups.
Swissmedic is harmonising its standards with those in the European environment to address nitrosamine contamination in pharmaceuticals
Date of news: September 14, 2022
Swissmedic wants to align its standards with those of the European community. The EMA has updated its Q&A guide several times after Swissmedic’s publication on nitrosamines on April 16, 2021. Therefore, Swissmedic is likewise upgrading its specifications based on the most recent iteration of this document and integrating significant amendments made public by the EMA.
Questions and answers regarding the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurity in human medical goods for marketing authorization holders and applicants
The implementation will take place in accordance with the legal requirements for therapeutic items. Departures from the EMA’s strategy may be necessary due to the constraints of Swiss healthcare.
News from EMA “Biosimilar medicines can be interchanged”
Date of news: September 19, 2022
According to a joint statement from EMA and the Heads of Medicines Agencies (HMA), biosimilar medicines authorised in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
Even while several Member States already utilise biosimilars interchangeably, this shared viewpoint harmonises the EU policy. It provides more clarity for medical practitioners and enables more patients around the EU to receive biological medicines.
Source: https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged
The suggested improvements to AI laws to enhance human control are welcomed by MedTech Europe
Date of news: September 19, 2022
MedTech Europe applauds the adoption of the opinion by the European Parliament’s Legal Affairs Committee, which conveys a strong message to the European Parliament’s leading Committees for Civil Liberties, Justice and Home Affairs (LIBE) and Internal Market and Consumer Protection (IMCO) on the importance of context-based human oversight, which is especially important in the healthcare sector.
Rules regarding the promotion of medications delivered via a different Northern Irish route are clarified by the MHRA
Date of news: September 20, 2022
Holders of valid NIMAR marketing authorizations shall manage the supply of NIMAR products in a manner comparable to those of medicines covered by NIMAR-specific regulations. However, because the medications on the NIMAR list are covered by GB licences, only England, Scotland, and Wales should actively promote them through advertising.
This does not exclude appropriate exchanges and communications required to keep up the supply of medications. Marketing authorization holders must follow Part 14 of the Human Medicines Regulations 2012 in all other respects and take all reasonable measures to ensure that advertisements do not run in areas where the medicine is not authorised.
FDA published draft guidance on “How To Obtain a Covered Product Authorization”
Date of news: September 21, 2022
According to the website, this draft document will replace the December 2014 draft guidance for industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. The draft guidance published in December 2014 guidance has been withdrawn.
In accordance with the CREATES Act, this document explains how qualified product developers can request a Covered Product Authorization (CPA) from FDA. The CREATES Act offers eligible product developers a means of gaining access to the product samples they require to satisfy testing and other legal requirements in order to support their applications. To use this pathway, as further explained below, an eligible product developer must first obtain a covered product authorization from the Agency (see 21 U.S.C. 355-2(b)(2)) in order to develop a product that is subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU).
Source: How To Obtain a Covered Product Authorization (fda.gov)
FDA published final guidance on “Electronic Submission Template for Medical Device 510(k) Submissions”
Date of news: September 22, 2022
This guideline outlines additional requirements for premarket notice (510(k)) submissions made in an electronic format, a timeline for their formation, and the standards that must be reached in order to be exempted or waived from a statutory requirement.
This guidance is also meant to act as one of several steps in fulfilling FDA’s goal to create electronic submission templates that will serve as guided submission preparation tools for business, improving consistency in submissions and boosting review process efficiency.
FDA has set October 1, 2023 as the deadline for when electronic 510(k) filings must be supplied.
MHRA published “The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA)” on its website.
Date of news: September 22, 2022
FDA received feedback in response to its draft guidance on therapeutic equivalence evaluations, Regulatory Focus, 20 July 2022)
Date of news: September 2022
Stakeholders in the generic pharmaceutical industry urged the US Food and Drug Administration (FDA) to drop its plan to require businesses to submit citizen petitions for therapeutic equivalence (TE) evaluations for 505(b)(2) applications, arguing that this procedure will not be effective and will harm companies that make complex generics. Additionally, they asked that the FDA refrain from removing discontinued medications from the Orange Book.
Source: https://www.regulations.gov/document/FDA-2022-D-0528-0002/comment
FDA published draft guidance on “Ethical Considerations for Clinical Investigations of Medical Products Involving Children”
Date of news: September 23, 2022
The FDA’s current position on ethical issues for pediatric clinical trials of medicinal goods is described in this document.
For information on the safety and efficacy of medications, biological products, and medical devices in children as well as to safeguard children from the dangers associated with exposure to potentially harmful or ineffective medical goods, clinical investigations in children are crucial.
Children are a vulnerable population that cannot give their own consent, so they are given extra protections when taking part in clinical research.
Such precautions are a crucial need for starting and carrying out pediatric research projects as part of a programme for developing medical products.
Pharma GMP News of the Week: 18-September-2022
Period: September 11, 2022 to September 17, 2022
News from EDQM – At the EDQM conference in Strasbourg, the Indian Pharmacopoeia Commission will be represented
Date of news: September 12, 2022
The EDQM will host the international conference “Collaboration, Innovation, and Scientific Excellence: the European Pharmacopoeia 11th Edition” in Strasbourg from September 19–21, 2022. The Indian Pharmacopoeia Commission (IPC) will participate.
Having recently been invited to participate in the PDG pilot project for worldwide expansion (“PDG welcomes Indian Pharmacopoeia Commission to pilot for global expansion”), the IPC will attend a session on the PDG. During this session, IPC will discuss their insights on pharmacopoeial harmonization. The WHO participates as an observer in the PDG. It will bring together the European Pharmacopoeia, the Japanese Pharmacopoeia, and the United States Pharmacopoeia.
FDA published draft guidance on “Computer Software Assurance for Production and Quality System Software”
Date of news: September 13, 2022
In order to provide suggestions on computer software assurance for computers and automated data processing systems used as part of the production of medical devices or the quality system, FDA is releasing this draft document. This proposed guidance is meant to:
- Give an explanation of “computer software assurance” as a risk-based strategy to develop trust in the automation employed in production or quality systems and indicate any areas where more rigor may be necessary; and
- Describe several techniques and testing procedures that could be used to establish computer software assurance and offer unbiased proof to satisfy legal requirements, such as the computer software validation standards in 21 CFR part 820. (Part 820).
Source: https://www.fda.gov/media/161521/download
A definitive list of alternatives and simplified procedures for current good manufacturing practise (CGMP) of combination products has been made available by the FDA
Date of news: September 13, 2022
FDA has published a list of guidelines for producers of combination products on what data is suitable to send as part of a CGMP process to FDA based on input from the industry. The agency stated, “[Combination product] makers should turn to applicable advice as the primary reference about what information to give when submitting information on a CGMP mechanism.
All content submissions for CGMP mechanisms must also include the applicable CGMP regulation, the applicable product, any prior interactions with the agency about the subject matter, a justification and supporting scientific data, and a justification for the exemption from 21 CFR part 820. The FDA then stated that they may determine if the justification offered by the combination product maker is acceptable.
FDA published final guidance “Q3D(R2) – Guideline for Elemental Impurities” on its website
Date of news: September 14, 2022
Elemental impurities in drug products can come from a variety of sources. For example, they can be leftover catalysts that were purposefully added during synthesis, or they can be present as impurities due to interactions with processing machinery, container/closure systems, or components of the drug product. Since elemental impurities do not benefit patients therapeutically, their levels in the medication product should be kept below reasonable bounds. This advice is broken up into three sections:
• Analyzing toxicity information for potential elemental impurities
• the use of a risk-based approach to regulate elemental contaminants in medicinal products; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological significance;
Pharma GMP News of the Week: 11-September-2022
Period: September 04, 2022 to September 10, 2022
PMDA Japan published English translation of guide to remote inspection procedure
Month news: August-September 2022
The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has translated its remote inspection method guide into English. The guide explains how businesses may prepare and distribute files for remote PMDA evaluation.
Source: https://www.pmda.go.jp/files/000247966.pdf
MHRA published details of Fees payable to the MHRA for 2022 to 2023
Date of news: September 5, 2022
MHRA published details of Fees payable to the MHRA for 2022 to 2023 for the following on its website.
- Active pharmaceutical ingredients manufacturers and importers registration: fees
- Active substance importers or distributors: fees
- Active substance manufacturers: fees
- Blood banks: application fees for a Review Panel hearing
- Blood banks and other blood establishments: fees
- Blood facilities: contract laboratories fees
- Broker registration fees
- Clinical trials: application fees
- Clinical investigations for devices: fees
- Drug-device combination products: fees
- Homoeopathic National Rules Scheme: fees
- Homeopathic National Rules Scheme: fees for inspections
- Inspection: fees
- Licence applications: marketing authorisation fees
- Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees
- Licence applications: parallel imports fees
- Licence applications: Phase 1 Accreditation Scheme fees
- Medicines export certificates: fees
- Periodic fees for holding a marketing authorisation
- Licence renewals, reclassifications and assessment of labels and leaflets: fees
- Orphan Marketing Products: fees
- Pharmacovigilance (PV) Safety Review: fees
- Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees
- Pre-Assessment (Rolling Review): fees
- Safety and quality vetting of unlicenced imported medicines fees
- Scientific advice meetings: fees
- Simplified Homeopathic Registration Scheme: fees
- Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees
- Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees
- Testing of samples: fees
- Traditional Herbal Registration Scheme: fees
- Variation: Homeopathic National Rules Scheme fees
- Variations: Homeopathic Simplified Scheme fees
- Variations: licence variations application fees
- Variations: licence variations applications groups fees
- Variations: other licence variations applications fees
- Variations: Traditional Herbal Registration Scheme fees
- Wholesale distribution authorisations: fees
- Fees: additional information
Source: https://www.gov.uk/government/publications/mhra-fees#full-publication-update-history
WHO Expert Committee published guideline on Biological Standardization – WHO Technical Report Series – 1043
Date of news: September 5, 2022
This WHO guideline exclusively focused on
Annex 1 – WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products
Annex 2 – WHO manual for the preparation of reference materials for use as secondary standards in antibody testing.
Annex 3 – Guidelines on evaluation of biosimilars, Replacement of Annex 2 of WHO Technical Report Series, No. 977
Annex 4 – Guidelines for the production and quality control of monoclonal antibodies and related products intended for medicinal use Replacement of Annex 3 of WHO Technical Report Series, No. 822
Annex 5 – New and replacement WHO international reference standards for biological products.
Source: https://apps.who.int/iris/rest/bitstreams/1462954/retrieve
News from EDQM – New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques
Date of news: September 8, 2022
Subsequent to the user inquiries via the EDQM HelpDesk, additional FAQs on the implementation of amended general chapter 2.2.46 have been published. Chromatographic separation techniques (11.0) have been added to the existing FAQs on European Pharmacopoeia and International Harmonization.
FDA published draft guidance on “Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products”
Date of news: September 8, 2022
The guideline recommends the structure and content of the mandatory statement of identity on human nonprescription pharmaceutical product labeling.
This document also includes recommendations for including the strength of the drug product on the labeling.
The suggestions in this guidance are designed to assist manufacturers, packers, distributors, sponsors and applicants, in ensuring that the statement of identity and strength for all human nonprescription medication products is uniform in content and structure.
Consistent content and structure of the declaration of identity and strength may help consumers compare nonprescription medicine goods and make appropriate self-selection decisions.
Source: https://www.fda.gov/media/161186/download
FDA published draft guidance on “Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products”
Date of news: September 8, 2022
This document contains guidelines for quantitative labeling of salt, potassium, and phosphorus in human prescription and over-the-counter (OTC) medications.
This recommendation covers salt, potassium, and phosphorus as components of active or inactive pharmaceutical substances (e.g., sodium as a constituent of the inactive ingredient anhydrous trisodium citrate, phosphorus as a constituent of the inactive ingredient dibasic calcium phosphate, or sodium as a constituent of the active ingredient naproxen sodium).
Orally consumed goods and injectable drugs containing 5 mg or more of salt, potassium, or elemental phosphorus per maximum single dose are included in the scope of this advisory. Individuals or institutions in charge of drug product labeling are advised to seek assistance from the FDA on specific instances.
Source: https://www.fda.gov/media/161194/download
MHRA published “Summary of responses to consultation – new Code of Practice for the Expert Advisory Committees”
Date of news: September 8, 2022
MHRA Press release – Introduces new conflicts of interest code of practice for independent advisors
Date of news: September 8, 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing a new, unified code of practise for all of its scientific advisory committees in order to ensure that the experts providing advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust, consistent, and transparent to all.
The new code of practise is the result of a six-week public consultation, which was launched in response to a key recommendation of the Independent Medicines and Medical Devices Safety Review for the MHRA to review how it identifies and manages potential conflicts of interest from members of expert advisory committees. The Commission on Human Medicines (CHM) and its expert advisory committees are among them.
FDA published final guidance on “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products”
Date of news: September 9, 2022
This recommendation encourages sponsors and applicants to indicate specific usage of RWD/RWE in their submission cover letters in order to facilitate FDA’s internal monitoring of submissions to the Agency that incorporate RWD/RWE. This recommendation does not impact FDA’s substantive examination of RWD/RWE submitted as part of the Agency’s routine review procedure.
This guidance applies to submissions for INDs, NDAs, and BLAs containing RWD/RWE intended to support a regulatory decision about product safety and/or efficacy.
Source: https://www.fda.gov/media/124795/download
News from EDQM – Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission to pilot for global expansion
Date of news: September 9, 2022
The PDG, which includes the European Pharmacopoeia (Ph. Eur. ), Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP), as well as the World Health Organization (WHO), welcome the Indian Pharmacopoeia Commission (IPC) as a participant in the PDG pilot for global expansion. This announcement follows the 2021 PDG Annual Meeting decision to launch a pilot for global membership expansion (“PDG prepares pilot for global membership expansion”), which was a critical first step in the PDG’s commitment to expanding the recognition of harmonised pharmacopoeial standards with the goal of achieving global convergence. The one-year expansion trial is set to begin with the PDG Annual Meeting, which will be held virtually in October 2022.
Source: https://www.edqm.eu/en/-/pdg-welcomes-indian-pharmacopoeia-commission-to-pilot-for-global-expansion
Pharma GMP News of the Week: 4-September-2022
Period: August 28, 2022 to September 3, 2022
News from TGA – Update to the Manufacturing Principles for medicines, APIs & sunscreens
Date of news: August 25, 2022
The Therapeutic Goods Administration (TGA) in Australia has provided information on the modifications brought about by the adoption of version 15 of the PIC/S Guide to GMP for Medicinal Products.
The objective of this adoption is, the TGA constantly updates and adopts the GMP guidance to:
- Give direction for the control of emerging technology;
- Fill up any gaps in the present compliance standards;
- Control risks discovered by legislation and inspections;
- Encourage ongoing developments in the production of medications.
Source: https://www.tga.gov.au/news/notices/update-manufacturing-principles-medicines-apis-sunscreens-0
The MDCG promotes hybrid audits. After hearing concerns from a variety of stakeholders on the lack of notified body capacity, the MDCG produced a position paper
Date of news: August 26, 2022
Following input from numerous stakeholders about their worries regarding the lack of notified body capacity, the MDCG produced a position paper on August 26. The organisation released a position paper with 19 points that it believes will help the issue.
Source: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf
MHRA seeks Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees
Date of news: August 31, 2022
This consultation’s goal is to gather input from interested parties on proposed changes to the Medicines and Healthcare Products Regulatory Agency’s statutory fees (MHRA). Three categories can be used to group the suggested changes:
- A 10% increase in indexation for all statutory fees
- 61 substantially underrecovering fees will receive a further increase in order to achieve cost recovery.
- Since the recent price revisions in 2016/2017 for medications and 2017/2018 for medical devices, there have been the introduction of 22 new fees for services that need cost-recovery.
The fee proposals outlined in this consultation aim to achieve full cost recovery in accordance with HM Treasury’s principles on Managing Public Money and ensure that the MHRA has the resources necessary to deliver the high-quality service that patients, the general public, and industry want and expect.
Source: https://www.gov.uk/government/consultations/consultation-on-proposals-for-changes-to-the-medicines-and-healthcare-products-regulatory-agencys-statutory-fees
Health Canada has adopted updated Guidance on nitrosamine impurities in medications from September 1, 2022
Date of news: September 1, 2022
News from MHRA “Canada – United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices”
Date of news: September 1, 2022
Health Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Veterinary Medicines Directorate (VMD) have agreed to broaden the current method of recognising GMP inspection results so as to include inspections conducted in nations outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections) for human and veterinary finished products included in the operational scope of Annex 1 of the Protocol for pharmaceuticals.
Source: https://www.gov.uk/government/publications/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices
The 11th Edition of the European Pharmacopoeia has a new general chapter on the implementation of pharmacopoeial procedures.
Date of news: September 6, 2022
The requirement more concisely stated in the Ph. Eur. General Notices is elaborated upon in this revised general text, which states that “when implementing a Ph. Eur. analytical procedure, the user must assess whether and to what extent its suitability under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems”.
A significant addition to the Ph. Eur. is the chapter Implementation of Pharmacopoeial Procedures (5.26), which offers more thorough information on one of the crucial procedures underlying the proper application of Ph. Eur. monographs.
Source: https://www.edqm.eu/en/-/new-general-chapter-on-implementation-of-pharmacopoeial-procedures-published-in-the-11th-edition-of-the-european-pharmacopoeia
Pharma GMP News of the Week: 28-August-2022
Period: August 21, 2022 to August 27, 2022
FDA issued draft guideline “Charging for Investigational Drugs Under an IND: Questions and Answers”
Date of news: August 23, 2022
This guidance provide information to industry, physicians, researchers,institutional review boards (IRBs), and patients about the implementation of the FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.
Since 2009, the FDA has received numerous inquiries on its implementation of the charging regulations. As a result, in June 2016, the FDA issued the final advice for industry Charging for Investigational Drugs Under an IND – Questions and Answers. Since the release of the final guidance, the FDA has received queries from stakeholders via the docket and discussions with review divisions.
Source: https://www.fda.gov/media/161079/download
News from EDQM – EDQM seeks support from industry stakeholders to provide feedback on availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
Date of news: August 23, 2022
Because of a change in the REACH Regulation ((EC) N° 1907/2006) that will be implemented in November 2021, European Pharmacopoeia experts have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), specified as plastic additive 01 in Ph. Eur. general chapter 3.1.14. Containers for aqueous solutions for intravenous infusion made of plasticized poly(vinyl chloride).
To aid in this reflection, the Ph. Eur. specialists would like to obtain information from manufacturers on the availability and use of containers for aqueous solutions for intravenous infusion that incorporate alternative plasticisers to DEHP in their composition for medicinal products.
Blog published by MHRA “Innovation, Quality & Transparency – a Compliance Team 1 Perspective”
Date of news: August 23, 2022
European Commission published final version of EU Annex 1: Manufacture of Sterile Medicinal Products – The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024
Date of news: August 25, 2022
After 14 years of study, the EU’s widely awaited amendment of its GMP Annex 1 for sterile medicinal products was announced on Thursday. The amended standards, which are slated to go into effect on August 25, 2023, apply to both domestic and imported sterile pharmaceuticals.
The current Annex I has been in force since 2008, with various proposed amendments since then. The most recent proposed amendment to the Annex was made available for public comment in early 2020, and over 2,000 comments were received.
There is a new section on pharmaceutical quality systems that combines quality risk management (QRM) principles into sterile medication manufacturing. There are other references to QRM throughout the document. A new section addresses the concept of a contamination control strategy (CCS) in decreasing contamination, as well as new sections that incorporate recent improvements in sterile processing technology in manufacturing, such as limited access barrier systems (RABS) and isolators.
The modification aligns sterile drug manufacturing principles with World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) standards, as well as with the US Food and Drug Administration’s (FDA) 2004 advice on sterile drug products created using aseptic processing.
Source: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
FDA issued Questions and Answers on “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential”
Date of news: August 26, 2022
The purpose of the question-and-answer (Q&A) document is to clarify important issues for industry on Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005).
This advice updates ICH E14 Q&As Q12 (5.1) and Q13 (6.1), as well as adding new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance is the final version of the draft guidance that was issued in September 2020.
Source: https://www.fda.gov/media/161198/download
FDA published draft guidance “Q2(R2) Validation of Analytical Procedures” on its website
Date of news: August 26, 2022
This guideline discusses elements to be considered during the validation of analytical processes contained in registration applications submitted to ICH member regulatory authorities. Q2(R2) gives instructions and recommendations for developing and evaluating the numerous validation tests for each analytical technique. This guideline is a compilation of terminology and definitions. These words and meanings are intended to bridge the gaps that frequently exist between various compendia and papers produced by ICH member regulatory agencies.
Source: https://www.fda.gov/media/161201/download
FDA published draft guidance “Q14 Analytical Procedure Development” on its website
Date of news: August 26, 2022
This guideline covers science-based and risk-based approaches to creating and maintaining analytical techniques appropriate for assessing the drug substances and drug products’ quality. The methodical approach proposed in ICH Q8 Pharmaceutical Development, together with the concepts of ICH Q9 QRM, can be applied to the development and management of analytical methods. A minimum (also known as conventional) approach or parts of an upgraded approach might be used while constructing an analytical technique. Furthermore, the guidance discusses factors to consider while developing multivariate analytical techniques and doing real-time release testing (RTRT). The objective of this guideline is to augment ICH Q2 Validation of Analytical Procedures.
Source: https://www.fda.gov/media/161202/download
FDA published draft guidance “M12 Drug Interaction Studies” on its website
Date of news: August 26, 2022
During the development of a therapeutic product, this guideline provides recommendations to support a consistent approach in conducting, developing, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies. A unified strategy will eliminate uncertainty for the pharmaceutical business in meeting the requirements of numerous regulatory authorities and will result in more efficient resource usage.
Source: https://www.fda.gov/media/161199/download
FDA published draft guidance “E11A Pediatric Extrapolation” on its website
Date of news: August 26, 2022
The purpose of the document is to make guidelines for, and to encourage worldwide harmonisation of, the use of paediatric extrapolation to aid in the development and approval of paediatric pharmaceuticals. Harmonization of paediatric extrapolation methodologies should lessen the chance of significant disparities between areas. Importantly, harmonisation could limit juvenile populations’ exposure to unneeded clinical trials while also facilitating more rapid access to paediatric medicines globally.
Pharma GMP News of the Week: 21-August-2022
Period: August 14, 2022 to August 20, 2022
FDA published Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
Date of news: August 15, 2022
The purpose of guidance is to assist in transmitting electronic individual case safety reports and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. An individual case safety reports (ICSRs) is a description of an adverse experience related to an individual patient or subject.
Source: https://www.fda.gov/media/98536/download
News from ICH “Addendum to S1B reaches Step 4 of the ICH Process”
Date of news: August 15, 2022
This document has been signed off on August 4, 2022. The document is developed based on a Concept Paper of Nov 14, 2012 and a Business Plan.
This addendum to ICH S1B is supported by scientific advances. Many retrospective study conducted by the agency confirmed that an integrative Weight of Evidence approach could be applied to adequately assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a 2-year rat study without compromise to patient safety.
As per the ICH, this is a more integrative and comprehensive approach to assessing human carcinogenic risk of pharmaceuticals.
Source: https://database.ich.org/sites/default/files/ICHS1B%28R1%29_Step4_Presentation_2022_0809.pdf
News from EDQM “11th edition of the European Pharmacopoeia now available in print”
Date of news: August 17, 2022
Source: https://www.edqm.eu/en/-/11th-edition-of-the-european-pharmacopoeia-now-available-in-print-1
India’s NPPA to take web portals offline from the 17 to 28 of August to upgrade pharma database
Month of news: August 2022
India’s National Pharmaceutical Pricing Authority (NPPA)’s web portal is offline from the 17 to 28 of August to upgrade the system. Therefore, Pharma Jan Samadhan, which is the government’s Digital India initiative if affected. The Integrated Pharmaceutical Database Management System (IPDMS) will be upgraded to enable companies to comply with the mandatory reporting requirements set out in the Drugs (Prices Control) Order, 2013.
Meanwhile, the agency will accept complaints regarding the nonavailability, overpricing, sales without price approval, shortage of drugs, and the refusal to supply medicines through email.
Source: https://www.nppaindia.nic.in/wp-content/uploads/2022/08/Auto-Color0112.pdf
Pharma GMP News of the Week: 14-August-2022
Period: August 7, 2022 to August 13. 2022
News from TGA – TGA is inviting applications from professionals with adequate expertise in science, medicine, or consumer perspectives and issues.
Month of news: August 2022
The chosen applicants will give independent expert advice on technical matters relating to the r medical devices, regulation of medicines, vaccines and other products/ substances.
These members will provide advice throughout the therapeutic product life cycle, from pre-market evaluation to post market product safety.
Source: https://www.tga.gov.au/vacancies-statutory-advisory-committees
Public consultation on TGA’s proposal for changes to the Permissible Ingredients Determination – Low-negligible risk
Month of news: August 2022
The chosen applicants will give independent expert advice on technical matters relating to the r medical devices, regulation of medicines, vaccines and other products/ substances.
These members will provide advice throughout the therapeutic product life cycle, from pre-market evaluation to post market product safety.
National Pharmaceutical Pricing Authority (NPPA, India) again extends price controls on medical devices
NPPA has proposed extending the price controls on identified medical devices from 31 July 2022 to 31 December 2022.
Source: https://www.nppaindia.nic.in/wp-content/uploads/2022/08/Gazett-Notification.pdf
Pharma GMP News of the Week: 7-August-2022
Period: July 31, 2022 to August 6, 2022
US FDA has published draft guideline on “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry”
Date of news: August 2, 2022
The purpose of this draft guideline is to assist ANDA applicants while submitting expedited safety reports of serious adverse events BA/BE studies in electronic form.
Serious adverse events have been submitted to the Office of Generic Drug through telephone, email, or facsimile transmission as attachments.
This document provides recommendations, specifications, and general considerations to send electronic submission of expedited safety reports.
Source: https://www.fda.gov/media/160561/download
MHRA is decommissioning of Suspected Unexpected Serious Adverse Drug Reactions (SUSARs)
Date of news: August 3, 2022
The MHRA is decommissioning the eSUSAR website to support Individual Case Safety Reports (ICSR) Submissions; providing users a more stringent, robust, and transparent process of SUSARs from Clinical Trials of Investigational Medicinal Products.
Source: https://mhrainspectorate.blog.gov.uk/2022/08/03/decommission-of-esusar/
News from EDQM – Deadline extension for Nitrosamines for all CEP holders to accomplish step 3 Revision to the CEP is October 1, 2023
Date of news: August 4, 2022
EDQM has published on its website that the European medicines regulatory network has agreed to provide extra time for submissions of Step 3, i.e. variation to the MA until October 1, 2023.
The extension is provided to allow organizations time to perform an adequate and detailed investigation and identify any required risk-mitigating actions.
However, the timeline for Step 2: confirmatory testing remains unchanged, i.e. September 26, 2022.
Pharma GMP News of the Week: 31-July-2022
Period: July 24, 2022 to July 30, 2022
US FDA published final guidance on “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices”
Date of news: July 25, 2022
The objective of this guideline is to include US FDA’s compliance policy related to GUDID submission requirements for certain devices of class I category.
The agency does not intend to enforce the Global Unique Device Identification Database submission requirements under 21 CFR 830.300 for devices of above class which are considered to be consumer health products and it is required to bear a UDI on its labels and device packages.
Furthermore, US FDA don’t want enforce the submission requirements of GUDID under 21 CFR 830.300 for above class and unclassified devices, other than life-supporting, implantable, or life-sustaining devices, regardless of its category as consumer health products, before 8-December-2022.
GUDID – Global Unique Device Identification Database
Source: https://www.fda.gov/media/110564/download
EDQM website seeks stakeholder consultation on draft guidelines for medication review
Date of news: July 26, 2022
As per EDQM website, the agency is seeking the opinions from stakeholders on its draft guidelines for medication review.
Source: https://www.edqm.eu/en/-/stakeholder-consultation-draft-guidelines-for-medication-review
US FDA published final guidance on “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry”
Date of news: July 27, 2022
The objective of this guideline is to applicants of INDs, NDAs, BLAs, and supplements to these applications planning to carry out neonatal populations’ clinical studies.
This document does not discuss the timing to start neonatal studies. This sponsor should discuss this topic with the relevant FDA review division.
Source: https://www.fda.gov/media/129532/download
News on EDQM website “General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition”
Date of news: July 27, 2022
General chapter 2.2.46. Chromatographic separation techniques have been revised to include the provisions of the pharmacopoeial harmonization text agreed by Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the Ph. Eur. (Effective date: 1 January 2023).
This general chapter applies to TLC, GC, LC and SE.
The key changes made to harmonize text are related to:
- Signal-to-noise ratio;
- The default symmetry factor range;
- Update on retention times and relative retentions;
- The system repeatability requirement for assay of active substances and excipients;
- For isocratic elution, adjustment of the stationary phase are stricter than in the former chapter;
- For gas chromatography, harmonization of the conditions for adjustment of the injection volume, column dimensions, injection port, split ratio, and transfer-line temperatures;
- Deleted the adjustments for supercritical fluid chromatography.
TGA updated nitrosamine impurity related information with respect to manufacturing requirements
Month of news: July 2022
The agency has updated the details on nitrosamine impurities for applicants and manufacturers. The updated version of information has a list of acceptable intake limits for different nitrosamines from animal carcinogenicity studies.
Few limits are derived from studies and others are extrapolated from closely related nitrosamine compounds. For more details, refer to the following link.
Source: https://www.tga.gov.au/alert/nitrosamine-impurities-medicines-information-sponsors-and-manufacturers
Pharma GMP News of the Week: 24-July-2022
Period: July 17, 2022 to July 23, 2022
US FDA published draft guidance – Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”
Date of news: July 21, 2022
The objective of this guideline is to support applicants to provide dose banding details into the drug labeling given in a NDA, BLA, or a supplement to these applications while the sponsor proposes to develop ready-to-use containers for different strengths and wants to add the dose banding details into the prescribing details of the proposed medicinal product that is depend on on dosing details of a already approved product which is based on weight or body surface area.
Source: https://www.fda.gov/media/160036/download
US FDA published draft guidance – Evaluation of Therapeutic Equivalence
Date of news: July 21, 2022
The objective of this guideline is to explain the criteria that the US FDA uses to evaluate the therapeutic equivalence of drug products. It also consists of therapeutic equivalence (TE) codes. The details covered in these documents are related to the FDA evaluation criteria for drug products to determine TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book).
Source: https://www.fda.gov/media/160054/download
US FDA published draft guidance – Conducting Remote Regulatory Assessments Questions and Answers
Date of news: July 22, 2022
The objective of this guideline is to explain FDA’s current thinking on use of remote regulatory assessments (RRAs) is to improve organizations’ understanding on RRAs and support FDA’s process to carry out RRAs.
Source: https://www.fda.gov/media/160173/download
US FDA published guidance – Orange Book Questions and Answers Guidance for Industry
Date of news: July 22, 2022
The objective of this guideline is to provide guidance to interested organizations covering prospective drug product and drug product applicants as well as approved application holders for utilizing the Approved Drug Products With TE Evaluation publication (that is Orange Book).
The document gives answers to generally asked questions that FDA have received regarding the Orange Book.
Source: https://www.fda.gov/media/160167/download
US FDA published guidance – Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
Date of news: July 22, 2022
The objective of this guideline is to support ANDA applicants in responding to CRLs from FDA. The guideline gives recommendations and information related to required actions for an ANDA applicant on receipt of a CRL, and the actions that FDA may take when ANDA applicants fail to revert on CRL.
Source: https://www.fda.gov/media/160166/download
News from EMA “Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making”
Date of news: July 22, 2022
To read an article published on the EMA website, click on the following link.
Pharma GMP News of the Week: 17-July-2022
Period: July 10, 2022 to July 16, 2022
CDSCO, India has published three draft guidelines on performance evaluation, postmarket surveillance and stability studies to reshape the manufacturer’s approach for vitro diagnostics (IVDs)
Date of guidances: July 7, 2022
To read the guidance, click to the following links.
News from EMA “EMA launches pilot project on analysis of raw data from clinical trials”
Date of news: July 12, 2022
The purpose of this pilot project is to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities enhances the evaluation of MAAs for post-authorisation applications as well as new medicines and to study the practical aspects of the data analysis and submission of data.
MDCG issued guidance on “Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)”
Date of news: July 13, 2022
Purpose of the guidance is to enable Member States and other relevant stakeholders to meet their obligations under the IVDR effectively simultaneously reducing any potential additional burden on the parties concerned.
This will be helpful when the exchange of information would be difficult, the possibility is nil, to get based on the corresponding provisions of Directive 98/79/EC.
FDA has published final guidance on “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format”
Date of news: July 15, 2022
The purpose of this guideline is to provide suggestions for developing the information and format of a patient Instructions for Use (IFU) document for human prescription drug and drug-led or biologic-led combination products as well as biological products submitted under NDA or BLA.
Source: https://www.fda.gov/media/128446/download
European Union (EU) Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC)
Date of news: July 15, 2022
The draft is an outcome of comprehensive revision of the current EU legislation that has included a huge consultation of international organizations active in the field and BTC stakeholders.
The objective of the drat provides the foundation for a robust and future-proof legislative framework that will provide better protection for both recipients and donors of BTC and improve the existing long-standing cooperation between the EU and the Council of Europe/EDQM.
ICH published draft Guideline presentation of ICH M12 on its website
Date of news: July 15, 2022
This Step 2 info Presentation has been prepared by the M12 Expert Working Group post publishing draft Guideline on Drug Interaction Studies.
Source: https://database.ich.org/sites/default/files/ICH_M12_Step2_Presentation_2022_0714.pdf
Pharma GMP News of the Week: 10-July-2022
Period: July 3, 2022 to July 9, 2022
FDA published draft guideline “Identifying Trading Partners Under the Drug Supply Chain Security Act”
Document published on: July 5, 2022
The FDA has issued the guideline to assist industry and stakeholders in understanding how to categorize the entities in the drug supply chain as per the DSCSA.
Source: https://www.fda.gov/media/159621/download
FDA published draft guideline “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry”
Document published on: July 6, 2022
The purpose of this guideline is to identify the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards.
This guideline is applicable for manufacturers, dispensers, wholesale distributors, and repackagers who are engaged in transactions of “products” as defined in section 581(13) of the Food Drug & Cosmetic Act.
Source: https://www.fda.gov/media/90548/download
News from EDQM “New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication”
Document published on: July 7, 2022
The purpose of this guideline is to provide guidance for the authors of monographs. This is the mode of communicating the principles for the elaboration and revision of monographs to the users of the Ph. Eur., specifically licensing authorities, industry, and official medicines control laboratories. This document also provides guidance with elaboration of specifications intended for inclusion in MA applications.
News from TGA “TGA updated recall procedure”
Month of news: July 2022
Two key modifications in the updated procedure are the removal of a section on crisis management guidance and inclusion of details on agency expectation to get in relation to recalls.
Source: https://www.tga.gov.au/sites/default/files/uniform-recall-procedure-therapeutic-goods-urptg.pdf
Pharma GMP News of the Week: 26-June-2022
Period: June 19, 2022 to June 25, 2022
News from CDSCO India, Ministry of Health’s proposal to add barcodes or quick response (QR) codes on around 300 top medicines to provide authentication. It will come into force in May 2023.
Government Document dated: June 14, 2022
US FDA issued Draft guidance “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures”
Date of guideline issuance: June 21, 2022.
Source: https://www.fda.gov/media/159294/download
News from ICH “The ICH Q3D(R2) Introductory Training Presentation is now available on the ICH website”
Date of news: June 23, 2022
As per the news from ICH, A Step 4 Introductory Training material is developed and it is available on the website.
Source: https://database.ich.org/sites/default/files/ICH_Q3D%28R2%29_Step4Presentation_2022_0527.pdf
US FDA published draft guidance on “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination”
Document issued on: June 24, 2022
The purpose of this guidance is to provide information of facility design elements, methods, and controls required to prevent product being cross-contaminated with compounds containing a beta-lactam ring.
It covers probable health risk, and the potential for cross-reactivity in the classes of non-antibacterial beta-lactam compounds and non-penicillin beta-lactam antibacterial drugs .
Source: https://www.fda.gov/media/159358/download
US FDA published final guidance on “Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry”
Document issued on: June 24, 2022
The purpose of this guidance is to provide suggestions on an alternate electronic format required to be submitted under an exemption from or a waiver of the provisions of FD&C Act, section 745A(a).
The scope of this guideline are:
NDAs, ANDAs, certain DMFs, BLAs, and INDs submitted to the CDER or CBER.
Source: https://www.fda.gov/media/159388/download
US FDA published final guidance on “Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations”
Document issued on: June 24, 2022
The purpose of this guidance is to provide suggestions to the applicants who are planning to perform food-effect (FE) studies for orally consumed drug products under INDs to support NDAs and supplements to these applications for drugs being developed under section 505 of the FD & C act. This document replaces and revises part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002).
Source: https://www.fda.gov/media/121313/download
MHRA update the guidance “Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending”
Document update: June 24, 2022
MHRA has updated the guidance to include Section ‘Guidance for The Conversion of PLGB or PLNI licences to PL’
Pharma GMP News of the Week: 12-June-2022
Period: June 5, 2022 to June 11, 2022
PIC/S releases work plan for 2022: Key highlights – onsite and desktop assessments, Annex 1 of the GMPs for sterile products, GMP Guide Chapter 1
Date of release: May 2022
Source: https://picscheme.org/docview/4697
U.S. FDA published guideline on “Electromagnetic Compatibility (EMC) of Medical Devices”
Date of notification: June 6, 2022
The objective of this document is to provide the guidance and recommendation on analysis to assess the electromagnetic compatibility of medical devices. Also the guideline provides information to include in the labeling. This document will help to improve the consistency and helps in reviewing electromagnetic compatibility in device submissions.
Scope of the document is medical devices, that also consists of in vitro diagnostics, and accessories that are electrically powered or works using electrical or electronic circuitry.
Source: https://www.fda.gov/media/94758/download
U.S. FDA announced pilot for lower radiation levels for device sterilization
Date of announcement: June 7, 2022
U.S. FDA is considering a master file pilot program for PMA (premarket approval) holders where approved devices are sterilized using radiation.
The objective of this consideration is because of global supply chain constraints and to support sterilization supply chain resiliency.
This program can help medical device manufacturers advance alternative ways to sterilize their approved medical devices.
EMA published its annual report of year 2021
Date of notification: June 10, 2022
The report brief about EMA’s role and preparedness for crisis and management of medicinal products and medical devices during major events and public health emergencies and facilitate faster approval of medicines.
The report also provides information about the Agency’s activities related to its new legal mandate.
Repost also speaks about EMA’s efforts to address health needs of patients beyond the pandemic.
As per the information on the website “EMA recommended 92 human medicines for marketing authorisation in 2021. Of these, 54 had a new active substance which had never been authorised in the EU before. This is a 38% increase compared to 2020, by far the highest number in the last five years”.
Source: https://www.ema.europa.eu/en/news/ema-publishes-annual-report-2021
Pharma GMP News of the Week: 5-June-2022
Period: May 29, 2022 to June 4, 2022
Official Medicines Control Laboratories (OMCLs) participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
Date of paper: May 31, 2022
In the year 2020, Recalls of many batches of metformin containing medicines have been done because of the detection of N-nitrosodimethylamine (NDMA) in amounts above the acceptable intake (AI) of 96 ng per day.
Before initiating the recall, OMCL participated in an international collaboration of regulatory laboratories to test the API and Finished Products for this impurity detection.
Detailed article on this topic “International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin‑Containing Medicines” at springer.com is available to read on the link below.
Springer published “Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency”
Published online on: May 24, 2022
Regulatory agencies do facility inspections to ensure Good clinical practice (GCP) are followed and to ensure the data integrity to safe-guard the rights, safety, and health conditions of study candidates. The inspections are being carried out to ensure that the clinical trials are done in compliance with GCP and inline with the applicable regulations.
The whitepaper published a study that compared outcomes on 49 GCP inspections carried out by the two agencies and summarizes the differences and similarities in findings for similar inspection deficiencies.
Source: https://link.springer.com/content/pdf/10.1007/s43441-022-00417-w.pdf
The ICH conducted a hybrid meeting on May 21 to 25, 2022, in Athens, Greece, for the first time.
Date of paper: June 1, 2022
The hybrid meeting was done where both in-person and virtual participation were present from 7 Groups, the MedDRA Management Committee, the ICH Management Committee, and the ICH Assembly.
Topic discussed and details of the meeting are:
- Further expansion of ICH Membership and Observership
- Progress on existing ICH Guidelines and harmonisation activities
- New areas of ICH harmonisation
- Training
- MedDRA
- Communication
For detailed reading refer link below.
The European Medicines Agency published a “Complex clinical trials – Questions and answers”
Published online on: June 2, 2022
The objective of this document is to support sponsors, applicants and clinical trialists to advise regarding scientific aspects and the planning, set-up, conduct, submission for obtaining CT authorisation (CTA), reporting and transparency, analysis and interpretation of complex clinical trials under the EU Clinical Trials Regulation as well as their use in submissions for MA.
Source: https://ec.europa.eu/health/system/files/2022-06/medicinal_qa_complex_clinical-trials_en.pdf
The European Commission published a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards
Date of notification: June 1, 2022
The European Commission published a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards for comments.
The standards are related to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Source: https://ec.europa.eu/docsroom/documents/50274/attachments/1/translations/en/renditions/native
Pharma GMP News of the Week: 29-May-2022
Period: May 22, 2022 to May 28, 2022
The EC’s Medical Device Coordination Group (MDCG) issued a Q & A to support industry to comply with unique device identification (UDI) requirements under the MDR and IVDR
Date of issue: May 20, 2022
The 45 pages report provides a comprehensive overview of its activities and achievements through the year 2021.
Topics covered under heading quality and use of medicines are – The European Pharmacopoeia, Reference standards, Certification of suitability to the Ph. Eur. monographs, The European Network of Official Medicines Control Laboratories, Response to nitrosamine contamination, Anti-falsification activities, Pharmaceuticals and pharmaceutical care and European Paediatric Formulary. To read the entire report, refer to the following source link.
Source: https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-7_en.pdf
The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) published on its website
Date of issue: May 23, 2022
The 45 pages report provides a comprehensive overview of its activities and achievements through the year 2021.
Topics covered under heading quality and use of medicines are – The European Pharmacopoeia, Reference standards, Certification of suitability to the Ph. Eur. monographs, The European Network of Official Medicines Control Laboratories, Response to nitrosamine contamination, Anti-falsification activities, Pharmaceuticals and pharmaceutical care and European Paediatric Formulary. To read entire report, refer to the following source link.
The European Medicines Agency has published the final revised guideline to supports development of new antibiotics
Date of issue: May 24, 2022
To support a global approach with respect to new antimicrobial medicines development, EMA has published this final guideline.
This guideline provides information on the evaluation of medicines that can be used for the treatment of bacterial infections.
The revised guideline consists of following:
- Suggestions and clarity about clinical development programmes;
- Guidance on clinical trials for UTI and Gonorrhoea;
- Showing microbiological and clinical data in the summary of product characteristics.
US FDA has published final guidance on “Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide”
Date of issue: May 25, 2022
The objective of the guideline is to help understand the rule, “Importation of Prescription Drugs,” that was published on 1-Oct-2020 (85 FR 62094).
The purpose of the final rule was to get a good amount of reduction in the cost of covered products to the American consumer with no additional risk to the public’s health and safety.
Pharma GMP News of the Week: 22-May-2022
Period: May 15, 2022 to May 21, 2022
US FDA published guideline on “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision”
Date of issue: May 16, 2022
FDA has revised the guidance on OOS applied to chemistry-based laboratory testing of drugs.
The document provides FDA’s current thinking on how to evaluate OOS test results.
Source: https://www.fda.gov/media/158416/download
US FDA published guideline on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”
Date of issue: May 17, 2022
The objective of this guideline is to provide information regarding US FDA’s Generic Drug User Fee Amendments of 2017 also called as GDUFA II (Title III of the FDA Reauthorization Act of 2017)
The document provides information about the new fee structure and types of fees applicable.
The guideline also gives information on how the US FDA determines affiliation for purposes of assessing generic drug user fees. For more details, read the source document.
Source: https://www.fda.gov/media/132138/download
US FDA published guideline on “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors”
Date of issue: May 18, 2022
The objective of this guidance is to support application holders, sponsors and applicants minimize medication errors regarding prescription drug and biological product applicable for humans.
In this guidance safety aspects of the application holder’s carton labeling and container label design are discussed.
The guidance provides a set of principles and recommendations to ensure key elements of a product’s carton labeling and container label to promote safe dispensing, administration, and use.
Source: https://www.fda.gov/media/158522/download
US FDA published draft guideline on “Risk Management Plans to Mitigate the Potential for Drug Shortages”
Date of issue: May 19, 2022
The objective of this guidance is to implement a risk based plan in order to support the prevention of human drug product and biological product shortages.
The plan will provide a framework to proactively identify, prioritize, and implement initiatives to prevent a supply disruption.
Source: https://www.fda.gov/media/158487/download
ICH published “2021 Free Text Comments Report and Consistent Cohort 2019 vs 2021 ICH Implementation Study”
Date of issue: May 19, 2022
The text has been published to analyze anonymised comments from the industry participating in the most latest survey done in 2021.
The purpose for this study was to:
- Provide further context to results from the survey
- Add value on informing training associates
- Inform future surveys.
https://www.ich.org/page/ich-guideline-implementation
EC updated its list of formally recognized and added risk management standard to harmonized standards list
Date of news: May 2022
The European Commission has formally added the EN ISO 14971:2019 standard in the reference list and amendment to the standard, EN ISO 14971:2019/A11:2021.
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0729&from=EN
EMA published document “Public Consultation Concerning The Physical Attendance And The Location Of Personal Residency Of The Qualified Person”
Date of paper: May 11, 2022
During the pandemic it required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode and that had an impact on standard way of working. In that perspective, to reduce the risks of shortages of medicine, and having high standards of quality, safety and efficacy medicines for the patients the EMA has published this consultation paper.
Consultation procedure: May 13, 2022 – June 13, 2022
Pharma GMP News of the Week: 15-May-2022
Period: May 8, 2022 to May 14, 2022
EMA updated “Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)”
EMA/INS/GCP/155794/2022
Date of update: May 05, 2022
Medical Device Coordination Group Document guidance provides clarity on permitted changes to devices launched ahead of IVDR
Month of publication: May 2022
Source: https://ec.europa.eu/health/latest-updates/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en
https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-6.pdf
US FDA published draft guideline on “Benefit-Risk Considerations for Product Quality Assessments”
Date of issue: May 09, 2022
The objective of this draft guideline is to provide information about benefit-risk principles applied by FDA when conducting product quality-related assessments of CMC information that have been submitted as part of original NDAs, BLAs in addition to other information available to FDA during its assessment.
The guidance covers details of sources of uncertainty and probable mitigation strategies with respect to product quality issues that may have potential effect on a product.
While considering the application, the agency considers the overall benefit and risk, and residual risk regarding unresolved product quality issues. The document discusses how to deal with unresolved product quality issues which can be addressed as part of regulatory decision making.
Source: https://www.fda.gov/media/158204/download
MHRA blog publishes “Compliance Monitor Process (Part 2) – CM role and application process”
Date of issue: May 10, 2022
On May 10, 2022 second part a two-part blog series on the CM Process that was piloted by the MHRA from April 2022. The second part of the blog gives information on the application process and CM role.
Source: https://mhrainspectorate.blog.gov.uk/2022/05/10/compliance-monitor-process-part-2-cm-role-and-application-process/
Pharma GMP News of the Week: 8-May-2022
Period: May 1, 2022 to May 7, 2022
EC proposed European Health Data Space to enable research opportunities
Date of news: May 3, 2022
The European Commission launched the EHDS (European Health Data Space). It will help the European Union to support the way healthcare is provided to people across Europe. This launch will enable people to control and use their data in other Member States or in their home country.
Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2711
New on by ICH: “The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”.”
Date of news: May 3, 2022
Source:
https://ich.org/news/midd-dg-guidance-roadmap
https://www.ich.org/page/reflection-papers
MHRA updated its guidance “Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland”
Date of update: May 04, 2022
The guidance is updated for “Register of Written Confirmations for UK active substance manufacturers”.
International Medical Device Regulators Forum (IMDRF) proposed document, “Principles and Practices for the Cybersecurity of Legacy Medical Devices” for public comment
Date of news: May 04, 2022
Source: https://www.imdrf.org/consultations/principles-and-practices-cybersecurity-legacy-medical-devices
EDQM published new on “New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates”
Date of news: May 5, 2022
As per the news Ph. Eur. commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form on its 172nd session in March 2022.
In this policy the difference between hydrates and solvates is explained. Hydrates are which have H2O as the solvent molecule.
The solvates are those that have an organic solvent.
US FDA published draft guideline on “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program”
Date of issue: May 06, 2022
FDA has announced a 3rd party quality maturity appraisal and continuous improvement program.
The intent of this program is to improve medical device quality and production. This is a voluntary program and does not mandate anyone to abide by the requirement. In this program participating manufacturer’s capability and performance will get reviewed with respect to key business processes. For more details, refer to the guidance.
Pharma GMP News of the Week: 1-May-2022
Period: April 24, 2022 to April 30, 2022
FDA Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research issued guidance on “Providing Submissions in Electronic Format — Postmarketing Safety Reports”
Date of issue: April 27, 2022
The objective of the guideline is to assist industry for regulatory submissions in electronic format to CDER and CBER. The document provides information regarding the electronic submission of postmarketing reports as per the following provisions of regulations:
21 CFR 314.98 and 314.80 – approved NDAs and ANDAs, including combination products or drug constituent parts with approved NDAs or ANDAs.
21 CFR 600.80 – approved BLAs, including combination products or biological product constituent parts with approved BLAs.
21 CFR 310.305 – prescription drug products marketed for human use those are not approved NDAs or ANDAs
21 CFR part 4, subpart B – additional reports for combination products with approved BLAs, ANDAs or NDAs
Source: https://www.fda.gov/media/71176/download
FDA Center for Drug Evaluation and Research issued guidance on “Electronic Submission of IND Safety Reports Technical Conformance Guide”
Date of issue: April 29, 2022
The objective of the guideline is to provide specifications, general considerations, and recommendations on how to submit electronic IND application safety reports to the CDER or CBER. This is the supplement guide to the draft guidance “Providing Regulatory Submissions in Electronic Format: IND Safety Reports dated October 2019”, as per requirements of section 745A(a) of the FD&C Act.
Source: https://www.fda.gov/media/132078/download
FDA Center for Drug Evaluation and Research issued guidance on “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products”
Date of issue: April 29, 2022
The objective of the guideline is to assist in electronic submission of individual case safety reports (ICSRs) and attachments to the CDER and CBER in the FDA . This guideline describes technical approach from FDA for submitting ICSRs, for adding its regionally controlled terminology, and for adding FDA FAERS regional data elements that are not given in the ICH E2B (R3) Implementation Guideline (IG) for the following products:
- NDAs and ANDAs for human use
- Prescription drug products for human use with no an approved applications
- OTC for human use
- BLAs for human use.
Source: https://www.fda.gov/media/98536/download
FDA Center for Drug Evaluation and Research issued guidance on “E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility”
Date of issue: April 29, 2022
Source: https://www.fda.gov/media/81913/download
FDA Center for Drug Evaluation and Research issued guidance on “E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility”
Date of issue: April 29, 2022
Source: https://www.fda.gov/media/81904/download
MHRA published Guidance on “Innovative Licensing and Access Pathway” that supports innovative approaches to the timely, safe, and efficient medicine development to improve patient access.
Date of last update: April 29, 2022
The ILAP aims to speed up the time to market and provide patient access to medicines. It covers biological medicines, new chemical entities, repurposed medicines, and new indications.
The Innovative Licensing and Access Pathway is open to non-commercial and commercial developers of medicines within the UK or global.
Note: ILAP – Innovative Licensing and Access Pathway
Source: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway#full-publication-update-history
MHRA published Guidance on “Compliance Monitor (CM) Overview and Application Process”
Date of publication: April 29, 2022
As per the MHRA website, they are going to run a pilot scheme to monitor organizations that fail to comply with GMP and GDP and are referred to the IAG post inspection and compliance escalation process being initiated for them. (Note: IAG – Inspection Action Group)
The process will support the agency in focusing resources on completion of the routine risk-based inspection for ensuring patient safety.
During this process IAG will monitor and support the implementation of an agreed Compliance Protocol. As per the details provided on the website, “A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process”.
This process from the CM will help the company to focus on remediation of the CAPA and augment the oversight of the MHRA.
Source: https://www.gov.uk/government/publications/compliance-monitor-cm-overview-and-application-process
PMDA, Japan published translation of “Amendment to Basic Principles on Global Clinical Trials”
Month of publication: April 2022
Source: https://www.pmda.go.jp/files/000246184.pdf
US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications (ANDA) with data integrity problems than companies with stronger culture. Yet officials continue to see data integrity problems across the board, affecting all elements of ANDA submissions.
Information on “Generic Drugs Forum 2022: The Current State of Generic Drugs” by FDA that conducted on April 26 – 27, 2022
As per the FDA representatives, organizations with weak quality cultures are more susceptible to have data integrity concerns in the submitted ANDA applications compared to the companies with stronger culture.
During this forum, FDA officials discussed the common deficiencies found in submitted ANDAs and lessons learned from remote interactive evaluations.
Watch entire Day 1 and Day 2 as using following videos:
Generic Drugs Forum 2022: The Current State of Generic Drugs – Day 1
Generic Drugs Forum 2022: The Current State of Generic Drugs – Day 2
European Commission’s Medical Device Coordination Group issued guideline to help define ‘borderline’ products
Month of issue: April 2022
The guideline is issued to clarify how developers identify the correct regulatory framework for these so-called “borderline”. This document provides a flowchart to determine whether the product is meeting the definition of a medical device under the MDR.
The purpose of the flow chart is to decide “whether a product fulfills the definition of a medical device per the MDR in order to ensure a consistent approach in the decisions concerning the borderline between medical devices and medicinal products.”
Source:https://ec.europa.eu/health/system/files/2022-04/mdcg_2022-5_en.pdf
ICH published “The ICH E8(R1) Introductory Training Presentation” on the ICH website
Date of publication: April 28, 2022
The ICH E8(R1) Guideline is related to General Considerations for Clinical Studies. The guideline is reached Step 4 of the ICH Process on 6 October 2021.
This Step 4 Presentation (Introductory Training) is developed by the Experts.
Source: https://database.ich.org/sites/default/files/ICHE8%28R1%29_Step4Presentation_2022_0408.pdf
Pharma GMP News of the Week: 24-April-2022
Period: April 17, 2022 to April 23, 2022
The HAD (Healthcare Distribution Alliance) issued guideline to support pharma industry for placement of bar code labels on their products to meet the Drug Supply Chain Security Act (DSCSA)
Date of issue: April 18, 2022
Source: https://www.hda.org/resources/2022-guidelines-for-bar-coding-in-the-pharmaceutical-supply-chain
FDA published final guidance on “Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry”
Date of issue: April 21, 2022
The objective of this guideline is provides guidance on the product development such as biological products having a nanomaterial in the finished dosage form.
The objective on nanomaterials in drug product may be different depending on the functionality. It could be active ingredients, carriers loaded with an active ingredient or inactive ingredients.
Pharma GMP News of the Week: 17-April-2022
Period: April 10, 2022 to April 16, 2022
FDA published Guidance on “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs”
Date of release: April 11, 2022
The objective of the guidance is to provide requirements of submission of promotional materials for human prescription drugs to the FDA, produced by made by Applicant, Manufacturers, Distributors, Packers, or Entity acting on behalf of the applicant. The guideline also explains aspects e-Submission of promotional materials in eCTD.
The guideline covers:
Advertising and promotional labeling materials, regardless of the manner, format, or medium of presentation. Examples of promotional materials are television ads, booklets, brochures, internet websites, detailing pieces, exhibits, print ads, radio ads, or sound recordings.
Source: https://www.fda.gov/media/128163/download
Press release from MHRA: “The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors”
Dare of news: April 12, 2022
MHRA has invited UK public and stakeholders to have their view on how the MHRA manages the conflicts of interest for experts those are independent and how involvement of patients in expert committee meetings to ensure transparency and consistency.
MHRA is open for consultation on a new Code of Practice for the Expert Advisory Committees
Date of news: April 12, 2022
MHRA is consulting on a proposals sets to strengthen and improve the Code of Practice for experts.
Where these expert are involved in giving advice that can be used for decisions about the regulation of medical devices and medicines. The objective of this guidance is to ensure that experts giving the advice and opinion as an independent entity and impartial, and process is robust and clear enough to to manage conflicts of interest.
This consultation closes at 11:45pm on May 24, 2022.
EMA and the EUnetHTA 21 joint work plan published “The European Medicines Agency and the European Network for Health Technology Assessment have published a joint work plan until 2023“
Date of news: April 12, 2022
There will be a close collaboration between EMA and Health Technology Assessment (HTA) bodies to bring synergy with the aims to facilitate patients’ access to medicines in the European Union.
Source: https://www.ema.europa.eu/en/news/ema-eunethta-21-consortium-set-priorities-their-collaboration
U.S. FDA published Manual of Policies and procedures “Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes”
Date of release: April 13, 2022
The document provides details regarding examples and definitions of drug-device combination products, complex drugs The document also outlined responsibilities and process for the Office of Generic Drugs’ Complex Drug Working Group.
Source: https://www.fda.gov/media/157675/download
FDA published draft guideline on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability”
Date of issue: April 13, 2022
The objective of this guideline is to recommend to sponsors who are in the process of developing medicinal formulations with the approach for evolving a Race and Ethnicity Diversity Plan to select representative Nos. of members from different populations in the US.
This approach helps to ensure that the data gathered during the development work reflect the racial and ethnic diversity and helps to identify effects on efficacy or safety outcomes associated with, or occur commonly within these populations.
Source: https://www.fda.gov/media/157635/download
FDA published draft Guidance on “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use”
Date of release: April 14, 2022
The objective of this guidance is to identify the information that US FDA commonly asks while evaluating pH adjusters waiver request for generic drug products intended for ophthalmic, parenteral, or otic use. The guidance is applicable for the applicants of ANDA.
Source: https://www.fda.gov/media/157655/download
News from MHRA: “Sunset clause: request for public health exemption”
On April 14, 2022, the information was updated to provide additional details regarding notification date for changes
Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Date of release: April 15, 2022
The objective of this guideline is to recommend applicants and sponsors for submitting (BA) bioavailability information for INDs, NDAs, and NDA supplements.
The requirement specified in this guidance is for dosage forms applicable for oral route of administration. It includes capsules, tablets, suspensions, solutions, IR, MR, ER, DR drug products.
The guidance also covers details regarding non-orally administered formulations that are appropriate to rely on systemic introduction to determine the BA (e.g., transdermal delivery systems, nasal drug products etc.).
The guideline is not applicable for ANDAs and ANDA supplements.
Pharma GMP News of the Week: 10-April-2022
Period: April 03, 2022 to April 09, 2022
MHRA update: “Medicines: reclassify your product – Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification”
Date of Update: April 4, 2022
Update: Updated Approved reclassifications to Mar 31, 2022
Source: https://www.gov.uk/guidance/medicines-reclassify-your-product
The FDA Office of Pharmaceutical Quality published a white paper “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals”
Date of white paper: April 05, 2022
The white paper is published with the aim of having a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.
Manufacturers reach to the quality management maturity (QMM) state when they have reliable, consistent, and robust processes to run business that achieves quality objectives and also it promotes continual improvement.
Source:
https://www.fda.gov/media/157432/download?utm_medium=email&utm_source=govdelivery
https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity
News from ICH “The ICH E11A draft Guideline reaches Step 2 of the ICH process”
Date of news: April 5, 2022
ICH E11A draft Guideline is open for public consultation as per the ICH news.
This guideline provide information related to
- The Paediatric extrapolation
- approaches that can be used and systematic approach for paediatric extrapolation
- Study designs and statistical analysis methods that can be usedfor a paediatric drug development plan.
Source: https://database.ich.org/sites/default/files/ICH_E11A_Document_Step2_Guideline_2022_0404_0.pdf
FDA published draft guidance “M7(R2) Addendum: Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes”
Date of issue: April 06, 2022
Source: https://www.fda.gov/media/157451/download
News from EDQM: EDQM Call for experts to join the Ph. Eur. network!
Date of news: April 06, 2022
The European Pharmacopoeia (Ph. Eur.) is looking for scientific experts independent to collaborate with EDQM experts and working parties.
Who can apply: It includes professionals from official medicines control laboratories, pharmacopoeial authorities, inspectorates, licensing authorities, private sector such as chemical or pharmaceutical industries, research organisations, academia, and other experts.
Source: https://www.edqm.eu/en/-/call-for-experts-join-the-ph.-eur.-network-2
FDA published final guidance “E8(R1) General Considerations for Clinical Studies”
Date of issue: April 08, 2022
The objective of this guideline is to help to design clinical studies, and to improve the quality of the studies to be submitted to regulatory agencies.
This includes:
(1) Protecting participants and getting reliable and significant results
(2) Address broad design
(3) Provide reference of other ICH guidance to conduct clinical research
Source: https://www.fda.gov/media/157560/download
FDA published draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
Date of issue: April 08, 2022
The scope of this guidance is applicable to medical devices having software/ firmware/ programmable logic and software as a medical device.
The scope is not limited to medical devices with network or other mode of connecting capabilities.
The guidance provides information regarding the cybersecurity that should be submitted while premarket submission of following types:
De Novo requests, Premarket Notification (510(k)) submissions, Premarket Approval Applications (PMAs) and PMA supplements, Investigational Device Exemption (IDE) submissions, Product Development Protocols (PDPs) and Humanitarian Device Exemption (HDE) submissions.
Source: https://www.fda.gov/media/119933/download
News from MDCG (Medical Device Coordination Group) – “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”
Month of News: April 2022
Source: https://ec.europa.eu/health/system/files/2022-04/md_joint-impl-plan_en.pdf
News from CDSCO, India: BSE certificates is not required if materials come from negligible risk countries
Month of News: April 2022
It has been proposed by India for its Medical Device Rules, 2017 that certain transmissible disease certificates are not required when sourcing animal products from negligible-risk countries.
Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODI4Nw==
Pharma GMP News of the Week: 27-March-2022
Period: March 20, 2022 to March 26, 2022
News from EDQM, “Metals and alloys used in food contact materials and articles: updated technical guide released for consultation”
Date of news: March 21, 2022
EDQM open the text for 2nd edition, for consultation by all concerned parties viz. business operators, national authorities, control laboratories and manufacturers from March 21, 2022 – April 29, 2022.
This edition includes:
- Alignment of text with Council of Europe Resolution;
- Updating of (SRLs) specific release limits, and (TDIs) tolerable daily intakes;
- use recommendations and quality requirements;
- Section about zirconium (New);
- Enhancement related to release testing;
- improvements in terms of uncertainty measurements.
FDA released final guidance on “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry”
Date of news: March 22, 2022
The objective of this FDA guidance is to provide guidance to manufacturers with respect to compliance requirements as per 21 CFR part 4 applicable for ophthalmic drugs packaged with eye droppers, eye cups, or other dispensers.
This guidance applies to approved products, pending applications, and products marketed under the section 505G of the FDA without an approved application under section 505 as per OTC monograph drugs).
FDA did not seek public comments prior to implementing this guidance because the FDA has determined that it is feasible or appropriate.
Source:
https://www.fda.gov/media/157067/download
https://freepub.edqm.eu/publications
IPEC (The International Pharmaceutical Excipients Council) releases guideline on “How to document to the ECHA’s Proposal for an EU-wide Restriction on Intentionally Added Microplastics Implications for pharmaceutical excipients, medicinal products and food additives”
Month of news: March 2022
IPEC has published how to guideline to help the pharmaceuticals to comply with latest labeling and reporting rules for microplastics which are intentionally included in pharmaceuticals.
Source: https://ipecamericas.org/sites/default/files/20220322_IE-IA-HowTo-Microplastics.pdf
DoP organization (India) is seeking comments on Uniform Code for Medical Devices Marketing Practices (UCMDMP).
This draft has been made in response to a request from the medical device industry. As per current requiring, the guidance is must to comply however, industry seeking own voluntary regulatory requirements.
Feedback will be accepted by DoP is until April 15, 2022.
Date of notice: March 16, 2022
Source: Indian Department of Pharmaceuticals (DoP) https://pharmaceuticals.gov.in/sites/default/files/DoP_Public%20Notice_Dated%2016032022.pdf
MHRA has granted a list of herbal medicines currently holding a traditional herbal registration.
Date of news: March 25, 2022
MHRA updated “Medicines: get scientific advice from MHRA”
Date of news: March 25, 2022
Source: https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra
Pharma GMP News of the Week: 20-March-2022
Period: March 13, 2022 to March 19, 2022
European Pharmacopoeia (Ph. Eur.) invites experts to join the Ph. Eur. network.
Date of news: March 14, 2022
Ph. Eur. is inviting independent experts to join Ph. Eur. groups and working parties. This includes experts from authorities such as official medicines control laboratories, pharmacopoeial authorities, inspectorates, and licensing authorities, and from private sector of chemical and pharmaceutical industries, research organisations, academia, etc.
Details of application are provided here.
Source: https://www.edqm.eu/en/news/call-experts-join-ph-eur-network-0
The long awaited EU’s revision of Annex 1 applicable for sterile drug products may be published in 2022, mid-year.
Date of news: March 14, 2022
The news is based on the announcement by Chairperson of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Paul Gustafson during ISPE Aseptic Conference on March 2014.
This regulation was drafted by EU, with the help of PIC/S and the WHO.
News from MHRA: Metformin in pregnancy shows no safety concerns
Date of news: March 15, 2022
As per the studies, it has been understood that there are no safety concerns relating to the use of metformin during pregnancy.
Now, the metformin can be considered for use during pregnancy as well is during periconceptional phase. This can be an addition or an alternative to insulin (when clinically needed).
Source: https://www.gov.uk/drug-safety-update/metformin-in-pregnancy-study-shows-no-safety-concerns
FDA released two draft guidelines –
(i) Human Gene Therapy Products Incorporating Human Genome Editing, and (ii) Human Gene Therapy Products Incorporating Human Genome Editing
Date of news: March 15, 2022
Source:
(i) https://www.fda.gov/media/156894/download
(ii) https://www.fda.gov/media/156896/download
European Pharmacopoeia to launch survey to have manufacturers’ opinion on use of total organic carbon (TOC) test in replacement of oxidisable substances test for WFI (Water for injections)
Date of news: March 17, 2022
Proposal for replacement of the test, (replacement of oxidisable substances test with TOC) was discussed with other Pharmacopoeias (Japanese Pharmacopoeia and United States Pharmacopeia,)
The purpose of this survey is to have official consultation from manufacturers on method and acceptance criteria for its appropriateness.
Survey: http://survey.edqm.eu/index.php?r=survey/index&sid=395252&lang=en
PICS published following seven guidance documents in Feb 2022 and March 2022 (up to Mar 19, 2022)
(i) Assessment and joint reassessment programme audit report (template) – PS/W 12/2002 (Rev.3, Draft 4)
Date of guideline: February 16, 2022
Source: https://picscheme.org/docview/4633
(ii) Joint reassessment programme procedure – PS/W 10/2005 (Rev 1, Draft 4)
Date of guideline: February 16, 2022
Source: https://picscheme.org/docview/4630
(iii) Travel guidance for on-site assessment visits – PS/W 9/2014 (Rev. 1, Draft 2)
Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4639
(vi) Assessment & joint reassessment programme cv for auditors (template) – PS/W 9/2002 (Rev. 2, Draft 1)
Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4637
(v) Assessment and joint reassessment programme criteria for observing inspections (template) – PS/W 11/2002 (Rev. 3, Draft 2)
Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4636
Assessment and joint reassessment programme procedure for observing inspections – PS/W 10/2002 (Rev. 3, Draft 2)
Date of guideline: March 1, 2022
https://picscheme.org/docview/4635
(vi) Guidelines for accession to the pharmaceutical inspection co-operation scheme – PS/W 14/2011 (Rev. 3, Draft 3)
Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4626
(vii) Guidelines for the pre-accession procedure1 – PS/W 12/2019 (Rev. 1, Draft 1)
Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4625
Pharma GMP News of the Week: 13-March-2022
Period: March 6, 2022 to March 12, 2022
EDQM published batch release guideline on Pandemic COVID-19 vaccine (Recombinant Spike Protein)
Date of news: March 8, 2022
FDA released draft guidance on “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs”
Date of news: March 09, 2022
The objective of this revised draft FDA guidance is to addresses and comply the requirement as amended by the Drug Supply Chain Security Act (DSCSA) of Federal Food, Drug, and Cosmetic Act (FD&C Act).
These compliance requirements are for
• Drug product manufacturers
• Wholesale distributors
• Repackagers
• Dispensers
The verification system required to be used to determine to be suspect and the quarantine and disposition of a product determined to be illegitimate.
The guidance also covers notification requirement when it is determined that the product is not an illegitimate product and cleared by manufacturer, wholesale distributor, repackager, or dispenser.
The guidance also covers the process for responding to requests for verification and processing returns.
Source: https://www.fda.gov/media/117950/download
FDA released final guidance on “Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions”
Date of news: March 11, 2022
Source: https://www.fda.gov/media/156729/download
MHRA has published blog “Compliance Monitor process (Part 1) – An introduction” on its website.
This is the 1st part of blog series on the Compliance Monitor process. This process will be piloted by the MHRA from April 2022.
Potential benefits of the program are:
The company will benefit from being able to concentrate on the delivery of the required improvements without having to divert their resources to manage MHRA supervision inspections to assess compliance remediation activities.
Under this pilot program, the GMP and GDP remediation will be supervised by eligible consultants that will act as Compliance Monitors. The potential benefits are:
• Agency resources can concentrate on routine risk-based inspection programme.
• Minimize potential shortages medicines supply using risk-based supervision and monitoring.
Date of news: March 11, 2022
Source: https://mhrainspectorate.blog.gov.uk/2022/03/11/compliance-monitor-process-part-1-an-introduction/
Pharma GMP News of the Week: 6-March-2022
Period: February 27, 2022 to March 5, 2022
WHO published working document “1.14.1 CHROMATOGRAPHY 3 Draft proposal” for inclusion of it in the International Pharmacopoeia, Working document QAS/21.905
Month of news: February 2022
The draft proposal by WHO covers text regarding TLC, HPLC and GC. The initial draft document was prepared by referring and internationally harmonized (by the Pharmacopoeial Discussion Group).
The document covers following topics:
• Definitions of Distribution constant, Peak-to-valley ratio, Dwell volume, Plate number, Plate height, Relative retardation, Separation factor, Resolution, Symmetry factor, Signal-to-noise ratio and, System repeatability
• System suitability
• Quantitation
• Detector response
• Interfering peaks
• Measurement of peaks
• Reporting threshold
FDA released final guidance on “Pre-Launch Activities Importation Requests (PLAIR)”
Date of news: March 01, 2022
The objective of this guidance is to describe the FDA’s policy about importation requests of unapproved drug products by applicants of NDA, and ANDA who is preparing for product launch in U.S. market based on anticipated approval.
The guideline is also applicable for biologics licensing applications (BLAs) for which NDA, BLA, or ANDA approval is anticipated.
Source: https://www.fda.gov/media/86243/download
FDA released final guidance on “Pre-Launch Activities Importation Requests (PLAIR)”
Date of news: March 01, 2022
As per the guidance, this master protocol is designed with multiple sub-studies. This guidance recommendation is applicable for drugs or biologics for the treatment of cancer.
The guidance recommends designing a master protocol to conduct clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure for adult and pediatric cancers.
Source: https://www.fda.gov/media/120721/download
As per EMA website, “Regulation on EMA’s extended mandate becomes applicable” from March 01, 2022
This is a structures and processes was established by EMA during the COVID pandemic on a more permanent footing. The agency is now responsible for medicine shortage monitoring, that may cause a crisis situation, and also reporting shortages of critical medicines during a crisis.
Source: https://www.ema.europa.eu/en/news/regulation-emas-extended-mandate-becomes-applicable
FDA released final guidance on “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C”
Date of news: March 03, 2022
The objective of this FDA guidance is to provide clarity on FDA’s expectation from industry and FDA staff regarding prompt initiation of voluntary recalls to recover unsafe goods from the market.
The document discusses about required preparations by firms with respect to distribution chain of distributors, and manufacturers’ procedure to initiate recalls; identification and prompt action; and to promptly communicate recall regarding information, press releases or any other public notices.
Source: https://www.fda.gov/media/123664/download?utm_medium=email&utm_source=govdelivery
Pharma GMP News of the Week: 27-February -2022
Period: February 20, 2022 to February 26, 2022
As per EMA website “European medicines regulatory network adopts EU common standard for electronic product information”
Date of news: February 22, 2022
On adoption of this process, it will provide key benefits of providing up-to-date and unbiased information to the patients regarding all the medicines approved in EU through the electronic means.
This will also include the product information of a medicine and will be helpful for healthcare professionals for all the medicines approved and authorized within the region of European Union.
Source:
EDQM towards making remote inspection as a permanent element of EDQM’s inspection scheme!
Date of news: February 23, 2022
In view of pandemic in 2020, there was an interruption in the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM). This situation lead EDQM to think on alternative approach of inspection and EDQM came up with Real-Time Remote Inspections (RTEMIS) to evaluate the company’s GMP compliance using live video streaming of facility and interaction with the manufacturing sites. They have started pilot phase in the month of November 2020 and carried out several remote inspection.
Based on plot phase, EDQM has arrived at conclusion that the approach is suitable to become an integral part of its inspection system. Now, in 2022, CEP applications may get notification for Real-Time-Remote Inspections as part of approval process.
MHRA announced “MHRA Good Practice Symposia Week (7 to 11 March 2022)” on its Blog site
Date of news: February 24, 2022
As per the website, MHRA will be hosting series of Symposia on Good Practice. It will be live stream and online event. This can be accessed by registered delegates as recordings after the symposium. The purpose of recording is to prevent difficult situation because of different time zone of attendees and people may not be able to watch completely in real time.
You can find more about this at https://mhra-good-practice-symposia.co.uk/home.
Source: https://mhrainspectorate.blog.gov.uk/2022/02/24/mhra-good-practice-symposia-week-7-to-11-march-2022/
FDA released new guidance on “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients”
Date of news: February 25, 2022
The objective of this guidance is to describe how stakeholders such as researchers, patients, medical product developers, and others should collect and submit the data that is related to the patient experience and other associated information from patients and caregivers. This is the second guideline in a series of four guidelines to provide methodological Patient Focused Drug Development.
Pharma GMP News of the Week: 20-February -2022
Period: February 13, 2022 to February 19, 2022
EMA published list of “Principal Documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP”
Date of document: February 14, 2022
The given list in the published document is not an exhaustive list. Section, “Good clinical practice”, on the EMA website also should consult for additional guidance documents.
Source: https://www.ema.europa.eu/en/documents/other/principal-documents-taken-account-preparation-procedures-gcp-inspections-requested-chmp_en.pdf
European Commission published Updated guideline “Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials”
Date of publication: February 14, 2022
Source: file:///C:/Users/krp00/AppData/Local/Temp/mp_eudralex_guideline-quality_en_0-1.pdf
European Commission published Updated guideline “Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials”
Date of publication: February 14, 2022
Source: file:///C:/Users/krp00/AppData/Local/Temp/mp_eudralex_guideline-chemical_en_1.pdf
As per EDQM news, Ph. Eur. adopts harmonised chapter on Chromatographic separation techniques (Chapter 2.2.46.)
Date of news: February 15, 2022
The text of chapter revised as per pharmacopoeial harmonisation text (agreed by Pharmacopoeial Discussion Group (PDG – the United States Pharmacopeia (USP), the Japanese Pharmacopoeia, and the Ph. Eur.). The agreement was done on September 28, 2021.
The revised text will be available in the 11th Ph. Eur. edition in the month of July 2022 and that will be implemented from 1 January 1, 2023.
Key changes are as follows:
EMA published PFD on “Human medicines highlights of 2021”
Date of news: February 15, 2022
As per the EMA, it recommended 90+ medicines for MA. 53 out of them are new API first time authorized in the EU, which is 30% more than 2020. For more details, download the PDF provided in the following link.
https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2021_en.pdf
FDA released its latest quarterly batch of product specific guidances (PSGs) to support generic drug development
Date of news: February 18, 2022
As per FDA notice the guidance “provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)”.
Source:
FDA Notice: https://public-inspection.federalregister.gov/2022-03248.pdf
https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm?utm_medium=email&utm_source=govdelivery
EMA updated the Union Product Database – FAQs for industry users
Date of publication: February 18, 2022
As per the EMA, the document is a compiled FQA asked by marketing authorisation holders (MAHs) on the usage of the Union Product Database (UPD) and its answers.
Pharma GMP News of the Week: 13-February -2022
Period: February 6, 2022 to February 12, 2022
EMA updated “Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”
Date of news: February 04, 2022
The EMA has updated question and answer guidance to provide guidance on how (MA) marketing authorization holders supposed to identify the risk and control it with respect to nitrosamines identified in formulation and active ingredients (APIs).
The guidance includes “Decision tree with control options for products containing multiple N-nitrosamines”
As per the guidance, there are following two acceptable options for determining nitrosamine limits when there are more than nitrosamines available. The approach helps to ensure not to exceed the acceptable risk level of 1:100,000 as outlined in ICH M7(R1) guideline:
- The sum of daily expose/ intake of all identified N-nitrosamines should not to be exceed the Acceptable Intake of the identified most potent N-nitrosamine
- The sum of all calculated N-nitrosamines risk level should not be exceeded is 1 in 100,000
FDA published draft guidance “Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry”
Date of news: February 07, 2022
The purpose of the graft guidance is:
- To provide recommendations and assist industries and parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small molecule drug or payload.
- The guidance reflects the FDAs current thinking on
- Clinical pharmacology considerations
- Recommendations for development that includes bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs).
- Specific emphasize on clinical pharmacology considerations of ADC development programs with appropriate reference.
Source: https://www.fda.gov/media/155997/download
FDA published “COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels”
Date of news: February 08, 2022
Purpose of this policy document is FDA’s concerns regarding safety of human. The guidance discourages development, approval, and usage authorization for sanitation tunnels (also called as disinfection/ sanitizing tunnels)
Examples are chambers, walkways, or similar arrangements that is made using sensor operated spray with a mist of sanitizing solution that gets sprayed when they passes through these tunnels.
Source: https://www.fda.gov/media/156027/download
EDQM have announced a Ph. Eur. tentative policy on assay RSDs
Date of news: February 09, 2022
As per EDQM, this tentative policy is applicable for monographs on medicinal products with chemically defined active substances – End of trial period postponed.
MHRA has published article on MHRA blog on “New year, new standards for investigational medicines”
Date of news: February 10, 2022
Recently, Clinical Trial regulation came into effect in the EU, “the Commission guidelines on good manufacturing practice for investigational medicinal products for human use” (It is revised Annex 13 of EU GMP).
Even though the EU is EU CTR will not be applicable for UK, the UK requirements will not get changed until completion of consultation on legislation for new proposals with respect to UK clinical trial. As per the blog, UK will be aligned with the globally harmonised standards of PIC/S and the EU, including requirements for the Qualified Person.
Pharma GMP News of the Week: 6-February -2022
Period: January 30, 2022 to February 5, 2022
MHRA published guidance for “Risk-Adapted Approach to clinical trials and Risk Assessments
Through this guideline, the agency is directing to the sponsors to carryout and record a formal risk assessment as early as possible to understand that the clinical studies falls under the Clinical Trials legislation, categorization of trial and possibility of barriers in execution of the studies. The topics covered under guidance are:
• When and how to undertake the risk assessment
• Retention and distribution of the Risk Assessment
• Revision of the Risk Assessment
• Investigator site staff experience and training in clinical trials/GCP etc.
• Submission of risk assessment to the MHRA and the REC
• Benefits of the risk assessment process
• GCP Inspections
• Examples of risk assessments
News from EDQM on new IT tool used to for sharing of EDQM documents secure between DCEP and CEP holders or applicants during the CEP lifecycle
Date of news: January 31, 2022
Source: https://www.edqm.eu/sites/default/files/medias/pa_ph_cep_21_62.pdf
FDA has published draft guidance on “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”
Date of issue: February 01, 2022
The guidance describes the process and mechanism for formal meetings between FDA and sponsors for an OTC drug.
This guidance describes the method how sponsors can receive suggestion on studies to support their applications.
The guidance also specifies types of meeting, formats of meeting, process of sponsors request, timelines of agency response on the meeting requests, package of meeting, and process of cancellation and rescheduling the meetings.
As per the guidance, there are three types of formats – Type X, Type Y and Type Z those are “otherwise stalled”, “milestone” and “meeting not fall under either of X or Y”.
Source: https://www.fda.gov/media/155864/download
PIC/S revised Guide to Good Manufacturing Practice (GMP) for Medicinal Products to include revised Annex 13 and new Annex 16.
Date of news: February 1, 2022
The revision of PIC/S Annex 13 is based on Clinical Trials on EC Regulation No. 536/2014. This guidance replaces EU Annex 13.
The Annex 16 is a new annex for the PIC/S. When the Annex 16 was adopted by EU, it was historically not adopted by PIC/S. Previously, this annex was considered by PIC/S as EU specific. After consultation of PIC/S Participating Authorities in 2017, it was considered to have beneficial to better convey expectations associated with product release
Source: https://picscheme.org/docview/4590
From next week, US FDA will resume routine domestic surveillance inspections
Date of news: February 02, 2022
On February 02, 2022, FDA announced that conducting domestic surveillance inspections will be begin from on February 07, 2022.
Source: https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022
FDA has published guidance on “Population Pharmacokinetics”
Date of issue: February 03, 2022
The purpose of this guideline is to support new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drugs (IND) applicants and sponsors with respect to population for pharmacokinetic (PK) analysis.
Source: https://www.fda.gov/media/128793/download
EDQM published a guide to reminds CEP holders about their responsibilities towards their customers
Date of news: February 03, 2022
EDQM experienced recently issues that have demonstrated the lack of knowledge of some CEP holders about their responsibilities and obligation towards their customers/ marketing authorization holders. EDQM has published a guidance document describing summarized CEP holders’ responsibilities.
Source: https://www.edqm.eu/sites/default/files/medias/pa-ph-cep_21_57_1.pdf
Pharma GMP News of the Week: 30-January-2022
Period: January 23, 2022 to January 29, 2022
FDA has published revised draft guidance on “Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry”
Date of issue: January 25, 2022
The purpose of the guideline is
(1) To help industry and ANDA holders in updating their labeling based on revisions of a reference listed drug (RLD) labeling.
(2) Helps to identify updates on revision of RLD labeling and submission requirements for ANDA holders.
Source: https://www.fda.gov/media/155661/download
FDA has published guidance on “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies”
Date of issue: January 26, 2022
As per the FDA, this purpose of this guidance is
(1) Engagement of patient volunteer to improve the design of medical device
(2) Advantages of above approach of using patient volunteer
(3) Criteria for selection of patient volunteer
(4) Q&A about misconceptions regarding collecting and submitting patient engagement information to the FDA
Source: https://www.fda.gov/media/130917/download
FDA has published guidance on “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation”
Date of issue: January 26, 2022
The intent of this guidance is:
1. To provide principles that can be used while Patient-reported outcome (PRO) uses instruments for the evaluation of medical devices;
2. Provide guidance about the significance of assuring the PRO instruments are fit for the intended use.
3. Provides brief about best practices to develop, modify, or adapt reliable, relevant, and sufficiently robust PRO instruments and using the minimum difficult approach.
Source: https://www.fda.gov/media/141565/download
FDA has published guidance on “Principles of Premarket Pathways for Combination Products”
Date of issue: January 26, 2022
This guidance provides outline about:
(1) General and high-level information about combination products
(2) How to coordinate and interact with FDA regarding combination product regulation
(3) Approach of FDA while reviewing the combination products before they are marketed.
(4) How to determine the type of premarket submissions that is appropriate for combination products.
Source: https://www.fda.gov/media/119958/download
FDA has published guidance on “Information Requests and Discipline Review Letters Under GDUFA”
Date of issue: January 26, 2022
The purpose of this guideline is to:
(1) Provide explanation about issuance and use IR (information request) and a DRL (discipline review letter) during the assessment of ANDA.
(2) Amendment to a supplement, supplement and amendment made in response to a CRL (complete response letter) does not covered under scope of this guidance.
(3) Commitment of FDA on performance goals for acting on received ANDAs
(4) Committed of FDA to provide preliminary thoughts on possible deficiencies when discipline finishes its initial assessment.
Source: https://www.fda.gov/media/109915/download
FDA has published guidance on “Good ANDA Submission Practices”
Date of issue: January 26, 2022
The intent of this guideline is to:
(1) Assist applicants in preparing to submit ANDAs.
(2) Provides an idea about common and recurring deficiencies to prevent delay in the approval of an ANDA.
(3) Provides recommendations that how to prevent such deficiencies that helps early approval.
Source: https://www.fda.gov/media/110689/download
Major change in Clinical Trials Regulation in the EU: Harmonistion of the assessment and supervision processes throughout the European Union as per Clinical Trials Information System (CTIS)
In EU region, clinical trials undergo a major change as soon as Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into effect on January 31, 2022. There will be a hamonisation in assessment and supervision processes through Clinical Trials Information System (CTIS) in entire EU. There will be a centralized portal and database for this purpose in EU.
Source:
The ICH published Training Material on E9(R1) its website
On 28 January 28, 2022 ICH announced the availability of training material on ICH E9(R1) “Addendum on estimands and sensitivity analysis in Clinical trials to the guideline on statistical principles for clinical trials”
Date of news: January 28, 2022
Source: https://database.ich.org/sites/default/files/E9%28R1%29%20Training%20Material%20-%20PDF_0.pdf
Pharma GMP News of the Week: 23-January-2022
Period: January 09, 2022 to January 22, 2022
MHRA’s new proposals for the future clinical trial legislation
Published on: January 17, 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has invited to contribute their views on far-reaching proposed revisions to the clinical trial legislation in the UK. As per MHRA, rhe objective of this proposal is to “improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines”.
Consultation period is eight-week.
Source:
https://www.gov.uk/government/news/new-proposals-for-the-future-of-uk-clinical-trial-legislation
FDA announced regarding extending On-Site Surveillance Inspections for another 2 Weeks Because Of Omicron
Date of news: January 21, 2022
FDA has announced that the US Food and Drug Administration is not going to conduct on-site surveillance inspections for another two weeks at a minimum.
The agency said on January 21, 2022 that “The FDA is extending the pause on domestic surveillance inspections through Feb. 4 with the goal of restarting these activities as soon as safely possible”.
As per FDA, “The agency continues to conduct both foreign and domestic mission-critical inspections … leveraging a variety of tools, including remote assessments and import operations surveillance”.
EU introduces clinical trials transformation initiative
Month of news: January 2022
Source:
EU release a note for version 5.0 of the Harmonised Technical Guidance for eCTD Submissions in the EU
Date for coming into effect (version 5.0): February 1, 2022
Harmonised Technical Guidance for eCTD Submissions new version has been drafted by the HHG and reviewed by the eSubmission Expert Group and the CMDh before it’s acceptance.
Harmonized guidance: http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v5.0_adopted%20version.pdf
Industry is asking more time for reporting manufacturing volume data that is required as per “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal FD & C Act; Draft Guidance for Industry (October 2021)”; under the “Coronavirus Aid, Relief, and Economic Security Act (CARES Act)”.
US FDA has recently publish the guidance “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal FD & C Act; Draft Guidance for Industry (October 2021)”; under the CARES Act. As per this guidance, each Drugmakers and active pharmaceutical ingredient (API) needs to provide the manufacturing volume they produced during the calendar year 2020 and calendar year 2021. These reports for calendar year 2020 need to be submitted February 15, 2022 and reports for calendar year 2021 need to be submitted by May 16, 2022.
The Association for Accessible Medicines (AAM) requested to FDA for delay the reporting date for 2020 data in September 2022.
Furthermore, PhRMA requested that FDA for exemptions for certain types of biologics to cover made-to-stock cell and gene therapy products. FDA proposed to exempt two categories of products from the reporting requirement and those are “blood and blood components for transfusion” and “cell and gene therapy products”.
Example format for reporting:
Pack wise and Month wise volume distributed
| ANDA No. | Product Name | Strength | Pack type | NDC | Jan 2020 | Feb 2020 | Mar 2020 | Apr 2020 | May 2020 | Jun 2020 | Jul 2020 | Aug 2020 | Sep 2020 | Oct 2020 | Nov 2020 | Dec 2020 |
Draft guideline: https://www.fda.gov/media/153665/download
Pharma GMP News of the Week: 9-January-2022
Period: January 02, 2022 to January 08, 2022
New European Pharmacopoeia texts and that have undergone technical revisions are published for comments.
Date of news: January 05, 2022
Total 48 drafts monographs published for comments on Pharmeuropa 34.1 and deadline for the comments is 31 March 2022.
Source: https://www.edqm.eu/en/news/pharmeuropa-341-just-released
ICH published brief overview ICH’s mission, structure and current work
Date of publication: January 05, 2022
ICH released a Leaflet on ICH’s mission, structure and current work.
Source: https://admin.ich.org/sites/default/files/inline-files/ICH_leaflet_2021_1221.pdf
MHRA updated guidance for regulating medical devices in the UK
Date of publication: January 01, 2022
The purpose of the guidance updated was to reflect changes to medical device regulatory requirements that will take effect from January 1, 2022. It covers what one should do to deploy a medical device in the Great Britain, European Union (EU) markets, and Northern Ireland.
Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
MHRA published official Statistics regarding expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.
Date of publication: January 04, 2022
Source: https://www.gov.uk/government/statistics/medicines-licensing-time-based-performance-measures
MHRA updated various documents and guidance from January 1, 2022 to January 7, 2022
Date of updates: January 1, 2022 to January 7, 2022
- Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)
- Clinical trials for medicines: apply for authorisation in the UK
- Apply for the early access to medicines scheme (EAMS)
- Innovative Licensing and Access Pathway
- Coronavirus (COVID-19) vaccines adverse reactions
- Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
- Importing medicines into Northern Ireland
- Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
- Notify the MHRA about a clinical investigation for a medical device
- Medicines: licensing time-based performance measures
- Human and veterinary medicines: register of licensed wholesale distribution sites
- Medicines: new manufacturing and wholesale dealer licences
- Register of brokers authorised to deal in human medicines
- Medicines: terminated and cancelled manufacturing and wholesale dealer licences
- Regulating medical devices in the UK
- Register medical devices to place on the market
Source: https://www.gov.uk
The eur-lex.europa.eu on January 04, 2021 officially acknowledged harmonized standards for medical devices that device manufacturers can use in order to comply requirements under the Medical Devices Regulation (MDR).
Date of publication: January 04, 2021
This includes:
Sterilization
Biological evaluation of medical devices
Aseptic processing
Use of symbols in product information
Quality management systems
According to the European Commission, “devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.”
Commission Implementing Decision (EU) 2021/1182 dated 16 July 2021
| Sr. No. | EN ISO Standard | Description of standard |
| 1. | EN ISO 25424:2019 | Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| 2. | EN ISO 11137-1:2015 | Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 3. | EN ISO 11135:2014 | Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| 4. | EN ISO 11737-2:2020 | Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
| 5. | EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
Commission Implementing Decision (EU) 2022/6 dated 4 January 2022
| Sr. No. | EN ISO Standard | Description of standard |
| 6. | EN ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
| 7. | EN ISO 10993-9:2021 | Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
| 8. | EN ISO 13408-6:2021 | Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 9. | EN ISO 11737-1:2018 | Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) |
| 10. | EN ISO 14160:2021 | Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) |
| 11. | EN ISO 13485:2016 | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| 12. | EN ISO 17664-1:2021 | Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| 13. | EN ISO 15223-1:2021 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021) |
| 14. | EN IEC 60601-2-83:2020 | Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment |
Source:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021D1182&from=EN
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0006&from=EN
FDA mission-critical work certain – inspectional activities has temporarily postponed
Date of press-announcements: January 4, 2022
According to press-announcements, “On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible”.
Source: https://www.fda.gov/news-events/press-announcements/fda-roundup-january-4-2022
Delay in Indian rules for use of unique device identifiers
Pharma GMP News of the Week: 2-January-2022
Period: December 26, 2021 to January 1, 2022
FDA published “Questions and Answers on Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations”
Date of release: December 29, 2021
On December 29, FDA published important Q&A regarding Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations. Key questions cover under this Q & A are:
“• What prompted development of the Concept of Operations (ConOps)?
• How does this effort relate to the recently announced Program Alignment initiative?
• Are there any additional details available regarding changes in timelines and communications for the specific inspection types?
• Can all facility owners expect final inspection classification communications within 90 days of inspection closing?
• How does FDA communicate the final inspection classification?
• Is the agency updating internal policies and procedural documents to reflect the ConOps?
• Will domestic and international facilities be evaluated differently?
• Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications? “
For further reading, refer to the following link.
Reflation on 2021: Guidance and important news published by different regulatory agencies and organizations in the year 2021.
| Agency | Description important updates for pharmaceuticals |
| EU | 6 Important Guidelines by EU in 2021 |
| MHRA | Several guidelines and 11+ important blog post by MHRA in 2021 |
| US-FDA | 12 Important Final Guidelines and 8 Draft Guidelines by US FDA in 2021 |
| ICH | 8 Important updates by ICH in 2021 |
Click on this link to find List of Pharmaceutical guidelines published in 2021
Pharma GMP News of the Week: 26-December-2021
Period: December 19, 2021 to December 25, 2021
For the first time, EMA has issued a list of regulatory science topics that need further research to improve medicine development and evaluation to enable access to innovative medicines for patients.
Date of news :December 15, 2021
According to the news, “EMA has identified around one hundred specific topics in the Regulatory Science Research Needs list. These topics, and the initiative itself, emerged from the stakeholder consultations which underpinned the development of the Regulatory Science Strategy to 2025”.
The topics are divided in the following four categories:
“(i) Integration of science and technology in medicines development, (ii) Collaborative evidence generation to improve the scientific quality of evaluations, (iii) Patient-centred access to medicines in partnership with healthcare systems, and (iv) Emerging health threats and availability/ therapeutic challenges”.
Source: https://www.ema.europa.eu/en/news/ema-launches-regulatory-science-research-needs-initiative
Download: https://www.ema.europa.eu/en/documents/other/regulatory-science-research-needs_en.pdf
According to the Press release by European Commission on EU-UK relations, “Commission delivers on promise to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta”
Date of press release: December 17, 2021
As per the press release “The Commission has put forward proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address outstanding supply concerns in Cyprus, Ireland and Malta. In the context of the Protocol on Ireland/ Northern Ireland, this means that the same medicines will continue to be available in Northern Ireland at the same time as in the rest of the United Kingdom, while specific conditions ensure that UK-authorised medicines do not enter the Single Market”.
Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6911
Download: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_21_6911/IP_21_6911_EN.pdf
FDA has publishes draft guideline on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”
Date of release: December 22, 2021
According the FDA, “guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products. DHTs may take the form of hardware and/or software and may be used to gather health-related information from study participants and transmit that information to study investigators and/or other authorized parties to evaluate the safety and effectiveness of medical products”.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/155022/download
MHRA has updated guidance for Update to post-Brexit protocols
MHRA webpage for “New guidance and information for industry from the MHRA” showing guideline updates from Decembers 2021.
Date of news: December 2021
Source: https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra
Pharma GMP News of the Week: 19-December-2021
Period: December 12, 2021 to December 18, 2021
FDA publishes draft guidance on “Inspection of Injectable Products for Visible Particulates”
Date of publication: December 16, 2021
The US Food and Drug Administration (FDA) on issued a draft guidance on “Inspection of Injectable Products for Visible Particulates” to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.
The draft guidance provides clarity that meeting an applicable U.S. Pharmacopoeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.
The draft guidance provides information regarding the development and implementation of a holistic, risk-based approach to control visible particulate. It describes about product development, manufacturing controls, visual inspection techniques, particulate identification, investigational and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/154868/download
European Pharmacopoeia (FP) Supplement 10.8 is available now
The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available on EDQM WebStore.
This is applicable for 39 European countries as of 1 July 2022.
This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur.
Source: https://www.edqm.eu/
FDA publishes draft guidance on “Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents”
Date of publication: December 16, 2021
As per the FDA, “FDA is issuing this guidance to clarify how the Agency interprets existing references to section 201(h) of the FD&C Act and how we intend to reference the definitions of “device” and “counterfeit device” going forward. This guidance is intended to provide clarity on references to the terms “device” and “counterfeit device” – as well as references to section 201(h) of the FD&C Act – in guidance, regulatory documents, and other communications and documents for FDA staff, industry, and other stakeholders.
Pharma GMP News of the Week: 12-December-2021
Period: December 05, 2021 to December 11, 2021
FDA publishes draft guideline on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators”
Date of publication: December 07, 2021
The objective of this draft guidance is to recommend CMC information require for investigational new drug application (IND) submitted by a sponsor who is developing an individualized antisense oligonucleotide (ASO) drug product for a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant where only a small number of individuals are prospectively identified (typically one or two).
Source: https://www.fda.gov
Download: https://www.fda.gov/media/154664/download
FDA publishes “draft guideline on IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations Guidance for Sponsor-Investigators”
Date of publication: December 07, 2021
The objective of this guidance provides recommendations for managing the administration of the individualized ASO drug product and conducting clinical assessments of the safety and treatment response during administration of the ASO drug product. The recommendations in this guidance are informed by experience with certain classes of well-characterized ASO drug products and by the ability to anticipate and manage some of the potential adverse events based on this prior experience with the ASO drug classes.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/154663/download
FDA publishes “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products”
Date of publication: December 08, 2021
The purpose of this guidance is to discusses the applicability of FDA’s IND application regulations under part 312 (21 CFR part 312) to various clinical study designs that utilize Real-World Data. The guidance also clarifies the Agency’s expectations related to clinical studies using Real-World Data submitted to Food and Drug Administration in support of a regulatory decision regarding the effectiveness and safety of a drug.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/154714/download
FDA publishes final guidance on “CMC Post approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports”
Date of publication: December 09, 2021
This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes CMC post approval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/106935/download
FDA publishes guidance on its website “Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry”
Date of publication: December 10, 2021
This published guidance gives information for permitted daily exposures (PDEs) for 3 additional residual solvents (RS): (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. The purpose of this document is to recommend permitted residue for above RS in pharmaceutical for the safety of the patient. The Q3C PDE levels are added and revised as new toxicological data for solvents become available.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/138334/download
FDA publishes draft guidance on “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry”
Date of publication: December 10, 2021
This draft document by FDA is published by FDA to assist prospective applicants, applicants, and holders of ANDAs with possible attachments which can be provided along with when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs, as well as original ANDAs, amendments, and supplements to approved ANDAs. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidance.
Source: https://www.fda.gov
Download: https://www.fda.gov/media/154762/download
MHRA has published interesting article on its blog on “Global reflections on international inspection transformation: ICMRA remote inspections”
Date of publication: December 10, 2021
In this blog article valuable insight provided about how global regulators have managed to perform regulatory oversight, inspections and assessments during the pandemic to support patients need and business continuity in terms of every aspects.
The article is linked with recently published white paper by ICMRA. ICMRA concluded that the “digital technologies in the remote conduct of inspections, evaluations, and assessments a key business continuity tool for regulatory oversight of certain activities and sites during the COVID-19 pandemic, which has proved valuable in the protection of public health in this emergency situation”.
White paper by ICMRA: https://www.icmra.info/drupal/sites/default/files/2021-12/remote_inspections_reflection_paper.pdf
European Commission’s Medical Devices Coordination Group (MDCG) provided new guidance “MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation”
Date of publication: December 9, 2021
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745.
The questions and answers describes on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Source:
https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf
https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-27_en.pdf
Pharma GMP News of the Week: 5-December-2021
Period: November 28, 2021 to December 04, 2021
FDA releases draft guideline: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry
Date of news: November 29, 2021
For the purposes of this guidance, a registry is defined as an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.
This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug’s effectiveness or safety.
Source: https://www.fda.gov/media/154449/download
MHRA updated guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
Date of guideline update: November 30, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom has added guidance on requesting a pharmacovigilance system master file (PSMF) number in it.
Source: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf#history
Pharma GMP News of the Week: 28-November-2021
Period: November 21, 2021 to November 27, 2021
The International Council for Harmonisation (ICH) met virtually on 17 and 18 November and Further expansion of ICH Membership and Observership
Date of news: November 25, 2021
The ICH has conducted virtual meeting on 17 – 18 November 2021 which was proceeded by ICH Management Committee and MedDRA Management Committee.
As per the ICH website, “the ICH Assembly welcomed COFEPRIS, Mexico as a new ICH Member, in addition to three new ICH Observers: EDA, Egypt, Indonesian FDA, Indonesia and SECMOH, Ukraine, bringing ICH to a total of 19 Members and 35 Observers”.
Source: https://www.ich.org/pressrelease/press-release-ich-assembly-virtual-meeting-november-2021
ICH Press Release: https://admin.ich.org/sites/default/files/inline-files/ICH43_VirtualMeeting_PressRelease_2021_1125_FINAL_0.pdf
FDA Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products
Content current as of: November 18, 2021
FDA site suggests that “the first of these possible mitigation strategies is derived from literature reports showing that commonly used antioxidants such as ascorbic acid (vitamin C) or alpha-tocopherol (vitamin E) inhibit the formation of nitrosamines in vivo based upon data from human gastric luid in vitro studies”.
Further to this, FDA website states that “A second possible approach is based upon the fact that the formation of nitrosamines typically occurs under acidic conditions, whereas, in a neutral or basic environment, the kinetics of these reactions are significantly reduced”.
FDA published An Update to the Resiliency Roadmap for FDA Inspectional Oversight
As per the US FDA update, “since April 1, 2021, FDA conducted more than 600 domestic and more than 200 foreign remote regulatory assessments, which included review of records submitted upon request under section 704(a)(4) authority, as well as review of documents and other information voluntarily submitted upon request where section 704(a)(4) does not apply”.
As per the update, “Between April and September 2021, FDA completed 124 foreign inspections across 23 countries”.
Source: https://www.fda.gov/media/154293/download
Major update on timelines for CEP applications by EDQM
Date of news: November 26, 2021
On October 1, 2021As per the EDQM started use of a new Information Technology tool for management of CEP applications. As per the update, timelines for evaluation of all CEP applications, revisions or renewal will be specified in business days instead of calendar days.
Source: https://www.edqm.eu/en/news/change-edqm-timelines-cep-applications
EMA vision for use of real-world evidence in EU medicines regulation
Date of news: November 24, 2021
As per the vision, “the creation of the Data Analytics and Real World Interrogation Network (DARWIN EU) will be key to delivering this vision”.
As per the EMA website “article explains plans to establish methods and standards for high-quality collection and use of RWE, in cooperation with stakeholders including patients, healthcare professionals, industry, regulatory and public health agencies, health technology assessment bodies, payers, and academia”.
Source: https://www.ema.europa.eu/en/news/vision-use-real-world-evidence-eu-medicines-regulation
Pharma GMP News of the Week: 21-November-2021
Period: November 14, 2021 to November 20, 2021
FDA conducted a virtual public meeting on November 16, 2021, on enhanced drug distribution security at the package level
Date of last update: November 15, 2021
The purpose of this public meeting was to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the DSCSA that go into effect in 2023.
FDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below:
• How is implementation of the 2023 enhanced system requirements progressing for your organization?
• What challenges is your organization facing?
• Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
• Are there areas in which FDA could provide more clarity?
MHRA has updated the guidance on “How investigators and sponsors should manage clinical trials during COVID-19” with respect to the section ‘Urgent Safety Measures’.
Date of update: November 16, 2021
As per MHRA guidance, “Since 16 November 2021, the notification of USMs to the MHRA should be performed following the standard procedure for USMs notifications as detailed here: Urgent Safety Measures”
Ireland’s Health Products Regulatory Authority (HPRA) posts guide to online controlled drug license system
Date of guideline: November 16, 2021
The National Drug Control System (NDS) allows users for application of import and export licenses for the various schedules of controlled substances in Ireland.
As per the guideline “NDS Web is a highly secure online licence application system for controlled drugs. This system allows users to apply for import and export licences for Schedule 1, 2, 3 and 4, Part 1 controlled substances, and letters of no objection (LONas) for Schedule 4 part 2 controlled substances.
This guidance document outlines the information available on NOS Web and the procedure to apply for an import licence, export licence or LaNa on NDS Web”.
Integration of EudraGMDP and OMS – Questions and answers from the webinar for industry on integration of EudraGMDP and OMS
Date of publication on EMA site: November 16, 2021
As per EMA “The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).
From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).”
Source: https://www.ema.europa.eu/en/events/integration-eudragmdp-oms-webinar-industry
Download Q and A: https://www.ema.europa.eu/en/documents/other/questions-answers-webinar-industry-integration-eudragmdp-oms_en.pdf
Australia’s Therapeutic Goods Administration (TGA) has published guidance on reclassification medical devices.
Published in: November 2021
As per the TGA, “From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for
Class IIa (low-medium risk), Class IIb (medium-high risk) or Class III (high risk) devices”.
As per the guidance, “This new classification rule is specific for devices composed of substances, or combinations of substances, that are intended to be introduced into the human body through an orifice or applied to the skin, and to be absorbed by, or locally dispersed, in the human body after introduction or application.
This aligns with EU Regulation 2017/745, rule 21 of Chapter III of Annex VIII”.
Pharma GMP News of the Week: 14-November-2021
Period: November 07, 2021 to November 13, 2021
US FDA Update: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Details as per content updated on FDA site upto November 08, 2021
U.S. FDA provided information on FDA website regarding upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development
Federal Register: https://public-inspection.federalregister.gov/2021-24431.pdf?utm_source=federalregister.gov
Pharmacopoeial Discussion Group (PDG) signs-off on milestone harmonised general chapter on chromatography
Date of news: November 08, 2021
As per the EDQM, “The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for this text was the Ph. Eur.”
The scope of this harmonization is applicable for TLC, HPLC, and GC.
For more information, read the following press release.
Press release: https://www.edqm.eu/sites/default/files/press-release-pheur-pdg-revised-chapter-chromatography-november-2021.pdf
Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5
Date of news: November 10, 2021
As per the news by PICS, “the PIC/S Working Group on Veterinary Medicinal Products (VMP), led by Grégory Verdier (France / ANSES), and the EMA GMP/GDP Inspectors Working Group have jointly developed two concept papers on the revision of Annex 4 (manufacture of veterinary medicinal products other than immunologicals) and Annex 5 (manufacture of immunological veterinary medicinal products) of the EU-PIC/S GMP Guide”.
Pharma GMP News of the Week: 7-November-2021
Period: October 31, 2021 to November 06, 2021
FDA published draft guideline on “Content of Premarket Submissions for Device Software Functions”
Document issued on: November 4, 2021
On November 4, 2021, FDA issues the guidance on “Content of Premarket Submissions for Device Software Functions”. The guideline outlining FDA thinking on the documentation needed to support the agency’s assessment of device software functions for premarket submissions. This draft guidance document is being distributed for comment purposes only.
According to the guideline, it is intended to cover:
• firmware and other means for software-based control of medical devices;
• stand-alone software applications;
• software intended to be operated on general-purpose computing platforms;
• dedicated hardware/software medical devices; and
• accessories to medical devices when those accessories contain or are composed of software.
FDA also provided clarity in terminologies used under this guideline.
As per the guideline “FDA refers to a software function that meets the definition of a device as a “device software function.” For example, a device software function may control a hardware device or be part of a hardware device (i.e., Software in a Medical Device, or SiMD) or be a device without being part of a hardware device (i.e., Software as a Medical Device, or SaMD).”
As per the FDA “the term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. For example, a product with an intended use to analyze data has one function: analysis”.
Source: FDA.gov
Link to the Guideline Document: https://www.fda.gov/media/153781/download
Federal Register notice: https://www.govinfo.gov/content/pkg/FR-2021-11-04/pdf/2021-24061.pdf
US Food and Drug Administration (FDA) has released the commitment letter of the Generic Drug User Fee Amendments (GDUFA III) program (For fiscal years 2023-2027)
News of the month: November 2021
As per the FDA, “this document contains the performance goals and program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, known as GDUFA III. It is commonly referred to as the “Goals Letter” or “Commitment Letter.” The Goals Letter represents the product of the Food and Drug Administration’s (FDA or the Agency) discussions with the regulated industry and public stakeholders, as mandated by Congress. The performance goals and program enhancements specified in this letter apply to aspects of the generic drug assessment program and build on the GDUFA program established and enhanced through previous authorizations”.
As per the letter, “New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles for abbreviated new drug applications (ANDAs) and facilitate timely access to quality, affordable, safe and effective generic medicines. Certain new enhancements are specifically designed to foster the development, assessment, and approval of Complex Generic Products”.
Source: fda.gov
Download:
https://www.fda.gov/media/153631/download
https://www.fda.gov/media/101052/download
India has issued Draft Policy to Catalyze Research & Development and Innovation in the Pharma – MedTech Sector.
Circular dated: October 25, 2021
Timeline for comments submission declared: November 2, 2021
As per the draft policy “this “Policy to Catalyze R&D and Innovation in the Pharma- MedTech Sector in India” is a commitment to encourage Research & Development (R&D) in pharmaceuticals and medical devices and to create an ecosystem for innovation in the sector in order for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. It acknowledges the need for greater emphasis on encouraging R&D, through indigenously developed cutting-edge products and technologies across the value chain”.
Download:
https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf
https://pharmaceuticals.gov.in/sites/default/files/R%20%26%20D%20PPT.pdf
TGA release update on GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.
Date of update: November 01, 2021
In this update, TGA has provided an update on certain temporary measures introduced last year for overseas manufacturers.
It includes details regarding:
• On-going use of Remote Inspections
• GMP Clearance
• Mutual Recognition Agreement (MRA) pathway
• Fees
EMA encourages companies to submit type I variations for 2021 in November 2021
News released on: October 29, 2021
According to EMA news, “the European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2021 and 3 January 2022 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008”.
Further to this, agency is advising that “Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3 December 2021 for a start of procedure in 2021. For submissions received on or after 6 December 2021, the procedure may not start until January 2022”.
Pharma GMP News of the Week: 30-October-2021
Period: October 24, 2021 to October 30, 2021
US, Canada, and the United Kingdom – Good Machine Learning Practice for Medical Device Development: Guiding Principles
Date of publication: October 27, 2021
According to FDA website, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
10 Guiding Guiding Principles are as follows:
1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle
2. Good Software Engineering and Security Practices Are Implemented
3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population
4. Training Data Sets Are Independent of Test Sets
5. Selected Reference Datasets Are Based Upon Best Available Methods
6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device
7. Focus Is Placed on the Performance of the Human-AI Team
8. Testing Demonstrates Device Performance during Clinically Relevant Conditions
9. Users Are Provided Clear, Essential Information
10. Deployed Models Are Monitored for Performance and Re-training Risks are Managed
Source: FDA.gov
Download: https://www.fda.gov/media/153486/download
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Pharma GMP News of the Week: 24-October-2021
Period: October 17, 2021 to October 23, 2021
FDA published draft guideline for comments “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” Comments to be submitted by January 21, 2022
Date of draft published: October 21, 2021
The 21st Century Cures Act, signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this action, calling for FDA to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).
Download: https://www.fda.gov/media/153341/download
On ICH’s 30th Anniversary, ICH has published document with an overview of ICH’s history and current work.
Date of news: October 19, 2021
ICH has announceed the publication of a 30th Anniversary document. This follows ICH’s 2020 celebration of 30 years of harmonisation activity. It provides an overview of ICH’s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH’s future directions in the next 10 years.
You can find the publication can be found on following link.
Source: https://ich.org
Pharmacopoeial Discussion Group (PDG) prepares pilot for global expansion of membership
Date of news: October 18, 2021
As per thenews by EDQM, the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised pharmacopoeial standards with a view to achieving global convergence.
Since it was founded in 1989, the PDG has successfully harmonised and maintained 29 general chapters, including such important analytical procedures as Dissolution Testing, Sterility and Microbiological Examination. In addition, the PDG has harmonised 46 excipient monographs and has approximately 20 new texts in its pipeline. The aim of the three founding pharmacopoeias is to extend this significant success story to further jurisdictions/regions and to create an inclusive global platform from which to elaborate harmonised pharmacopoeial standards.
Download document for more information: https://www.edqm.eu/sites/default/files/medias/fichiers/PressRelease/press-release-pheur-pdg_prepares_pilot_for_global_expansion-october_2021.pdf
Source: https://www.edqm.eu/
Source: https://www.fda.gov/
The US House of Representatives passed a following bill on October 19, 2021, H.R. 4369, which promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing.
H.R. 4369, the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act,” was introduced by Pallone and Health Subcommittee Ranking Member Brett Guthrie (R-KY). The bill would amend the 21st Century Cures Act to provide the Food and Drug Administration (FDA) with the authority to designate institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing for pharmaceuticals as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing. Such Centers would work with FDA to craft a national framework for advanced and continuous pharmaceutical manufacturing, including workforce development, standardization, and collaboration with manufacturers. The bill passed on the House Floor by a vote of 368-56.
The bill would designate certain universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, allowing them to work with FDA and industry to further develop and implement advanced and continuous manufacturing technology. The bill would also authorize $100 million in funding to support the effort. Pallone spoke in favor of the bill on the House floor.
European Commission has provided draft Clinical Trial Regulation (Version 4.1 (September 2021) – Clinical Trials Regulation (EU)No 536/2014 Draft Questions & Answers)
Date of release: October 14, 2021
The European Commission has published an updated question and answer guidance on the Clinical Trials Regulation (CTR), which is ready to go into effect this January.
Download: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf
Pharma GMP News of the Week: 10-October-2021
Period: October 3, 2021 to October 9, 2021
News from FDA: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
Date of issue: October 6, 2021
This Addendum is to be used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines.
Download draft guideline: https://www.fda.gov/media/152777/download
Source: https://www.fda.gov
ICH published ICH M7(R2) draft Guideline and Addendum reaches Step 2 of the ICH process
Date of issue: October 6, 2021
The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period.
The ICH M7 (R2) Addendum provides useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.
7 new compounds have been added in this revision: Acetaldehyde, Dibromoethane, Epichlorohydrin, Ethyl Bromide, Formaldehyde, Styrene, and Vinyl Acetate.
Additionally, a Step 2 Informational Presentation has also been developed by the Maintenance Expert Working Group.
Source: https://www.ich.org/
News from ICH: The ICH E8(R1) Guideline reaches Step 4 of the ICH Process
Date of news: October 6, 2021
The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.
This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.
Download: https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf
Source: https://www.ich.org/
Drug Administration (FDA) has revised its guidance with more flexibility – Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Date of issue: October 6, 2021
This revised draft guidance describes how FDA intends to apply certain provisions of section 503A of the FD&C Act to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient (section 503A(a) of the FD&C Act). Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D) of the FD&C Act). This guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals.
Download: https://www.fda.gov/media/97353/download
Source: https://www.fda.gov
The European Commission’s Medical Devices Coordinating Group (MDCG) on October 04, 2021 issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.
Date of issue: October 04, 2021
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121.
Download: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
Source: https://ec.europa.eu/
The European Commission (EC) published new document “Good Lay Summary Practice” (“GLSP”), with recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language.
Date of publication: October 04, 2021
This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“EU CTR”) and a transparency obligation to all trial participants and the interested public.
Download: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/glsp_en.pdf
Source: https://ec.europa.eu/
The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Date of publication: October 05, 2021
This final rule establishes procedures and criteria related to requests for De Novo classification (“De Novo request”) and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation.
Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa
Date of news: October 06, 2021
A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021.
This draft monograph is the outcome of a thorough examination of the substantial response to the request for feedback issued in April 2020 and which prompted lively and constructive discussions with regulatory experts in the field, as well as a series of dedicated Ph. Eur. expert meetings.
Source: https://www.edqm.eu/
Pharmeuropa 33.4 released
Date of news: October 5, 2021
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.4 is 31 December 2021.
Source: https://www.edqm.eu/
European Pharmacopoeia Supplement 10.7 available
Date of news: October 04, 2021
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022.
This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions are already available to purchase via the EDQM Store.
Source: https://www.edqm.eu/
Pharma GMP News of the Week: 3-October-2021
Period: September 26, 2021 to October 2, 2021
News from MHRA Inspectorate blog: Updated data integrity requirements for GLP Monitoring Programme members
Date of news: September 27, 2021
The MHRA published the GXP Data Integrity Guidance in March 2018 and has subsequently led the development of an Organisation for Economic Co-Operation and Development (OECD) advisory document on data integrity.
The MHRA GXP Data Integrity Guidance was always intended to sit alongside additional regulatory guidance and should also continue to be used to supplement and support UK GLP facilities as it provides additional guidance primarily associated with the importance of a supportive organisational culture in order to embed and foster a strong data integrity culture within organisations.
The new OECD Data Integrity Advisory Document can be found here:
Source: https://mhrainspectorate.blog.gov.uk/
FDA has published draft guideline on: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
Date of publication: September 28, 2021
FDA states that the 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this section, FDA created a framework for a program to evaluate the potential use of real-world evidence (RWE) to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help to support or satisfy postapproval study requirements (RWE Program).
Download: https://www.fda.gov/media/152503/download
Source:https://www.fda.gov
FDA has published draft guideline on “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices”
Date of publication: September 29, 2021
As per FDA, this guidance is intended to help clinical investigators comply with the following safety reporting requirements:
Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 312.64(b)
Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)
Recommendations are provided to help investigators identify the following:
1. For drugs — Identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) under § 312.66 (21 CFR 312.66)
2. For devices — Identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs under § 812.150(a)(1) (21 CFR 812.150(a)(1))
Download: https://www.fda.gov/media/152530/download
Source: https://www.fda.gov
FDA has published draft guideline on “Microbiological Quality Considerations in Non-Sterile Drug Manufacturing”
Date of publication: September 29, 2021
As per FDA, this guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). NSDs can be prescription or nonprescription drugs, including those marketed under approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and nonprescription drugs without approved new drug applications which are governed by the provisions of section 505G of the FD&C Act (often referred to as over-the-counter (OTC) monograph drugs). These recommendations, if followed, will also assist manufacturers in complying with the current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs).
Download: https://www.fda.gov/media/152530/download
Source: https://www.fda.gov
FDA has published draft guideline on “Benefit-Risk Assessment for New Drug and Biological Products”
Date of publication: September 29, 2021
According to FDA, the intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as biologics license applications (BLAs) submitted under section 351(a) of the Public Health Service Act (PHS Act). This guidance first articulates important considerations that factor into the Center for Drug Evaluation and Research’s (CDER) and the Center for Biologics Evaluation and Research’s (CBER) benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment. It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as how they may…
Download: https://www.fda.gov/media/152544/download
Source: https://www.fda.gov
FDA published final version of Q3B(R) Impurities in New Drug Products (Revision 3) on FDA site
Date of publication: September 29, 2021
This guidance provides recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or member state. This guidance revises the ICH guidance of the same title that was issued in May 1997 and first revised in February 2003. The first revision clarified the 1997 guidance and included other changes. The revision also provided consistency with more recently published ICH guidances (e.g., Q3A(R) Impurities in New Drug Substances, Q3C Impurities: Residual Solvents, and Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances). This second revision provides clarification to Attachment 2.5
This guidance complements the ICH Q3A(R) guidance, which should be consulted for basic principles along with ICH Q3C when appropriate.
Download: https://www.fda.gov/media/71733/download
Source: https://www.fda.gov
EMA implements new measures to minimise animal testing during medicines development
EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.
ITF is a dedicated forum for early dialogue between regulators and developers of medicines to discuss innovative aspects such as emerging therapies, methods and technologies. Set up to ensure coordination across the Agency, the ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It will provide an opportunity to discuss 3R-compliant methods and facilitate their integration into the development and evaluation of medicinal products.
Source: https://www.ema.europa.eu/
EU agencies have updated their notice to specify that GMP and GDP certificates, and other time-limited authorizations are extended up to the end of 2022.
Date of publication: September 30, 2021
European regulators announced that good manufacturing practice (GMP) and good distribution practice (GDP) certificates and other authorizations shall be extended upto 2022.
This document provides guidance to marketing authorisation holders of medicinal products for human use (“MAH”) on regulatory expectations and flexibility during the COVID-19 pandemic. The document will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic. For queries related to specific products that are not specifically addressed in this document, MAHs are invited to address the European Medicines Agency (for centrally authorised products) or the relevant national competent authorities (for nationally authorised products).
This document remains valid until further notice. It has been developed in cooperation between the European Commission, the Coordination group for Mutual recognition and Decentralised procedures – human (“CMDh”), the Inspectors Working Group and the European Medicines Agency (“EMA”).
The ultimate responsibility for the interpretation of EU legislation is vested on the European Court of Justice and therefore the content of this document is without prejudice to a different interpretation that may be issued by the European Court of Justice.
See the notice: https://ec.europa.eu/health/sites/default/files/human-use/docs/guidance_regulatory_covid19_en.pdf
FDA issued draft guidance on Electronic Submission Template for Medical Device 510(k) Submissions for comment purposes
Document issued on September 29, 2021.
FDA is issuing this draft guidance document to introduce submitters of premarket notification
(510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
Download: https://www.fda.gov/media/152429/download
Source: https://www.fda.gov
WHO is requesting input on draft guideline on WHO Biowaiver Project- Preparation for cycle V 5 (2022):
Prioritization exercise of active pharmaceutical ingredients on the WHO Model List of Essential Medicines for solubility determination and Biopharmaceutics Classification System-based classification.
EDQM news: Certification of suitability: revised terms of reference and rules of procedure
Date of news: September 27, 2021
A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM): Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1, 12 R).
This revision was undertaken to clarify the title and certain working procedures, and to take into account organisational changes in the EDQM Certification of Substances Department.
Pharma GMP News of the Week: 26-September-2021
Period: September 19, 2021 to September 25, 2021
U.S. FDA published very useful guidance “Questions and Answers on Quality Related Controlled Correspondence – Guidance for Industry”
Date of publication: September 20, 2021
This questions and answers (Q&A) guidance provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions.
Questions covered in the guidance are:
a. Is it acceptable to use a bracketing approach for the manufacture of the exhibit batches of a generic drug product with multiple strengths produced from common bulk granulations (or blends)? Do all of these exhibit batches need to be put into the stability program?
b. If the reference listed drug (RLD) is a sterile injectable drug product packaged in an ampule, can the generic product be packaged in a vial?
c. Should a proposed generic ophthalmic drug product have the same cap color as the RLD when that color is not in line with the American Academy of Ophthalmology (AAO) recommendation?
d. If the dissolution method for a proposed generic drug product is not available in the FDA Dissolution Methods Database or in the United States Pharmacopeia (USP), can the Agency provide the dissolution method for the product?
e. How should a bacterial endotoxins test acceptance criterion be determined for the finished drug product?
f. Is it acceptable to omit bacterial endotoxin limits in the proposed specification for a topical ophthalmic drug product?
g. If an applicant intends to have more than one drug product manufacturing site in an abbreviated new drug application (ANDA), how many exhibit batches should be provided for each site?
h. If the generic drug product is a “for injection” (sterile lyophilized powder), can stability data for exhibit batches be generated using only one orientation?
i. If a product is packaged using blow-fill-seal technology and the container is composed of a single material, can stability data for exhibit batches be generated using only horizontal or upright orientation?
j. Should the three exhibit batches for a generic product be fully packaged in the proposed marketed packaging?
Source: https://www.fda.gov/media/152281/download
MHRA has updated information about Consultation on the future regulation of medical devices in the United Kingdom
Date of update: September 23, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has invited members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).
MHRA wants to develop a future regime for medical devices which enables:
Improved patient and public safety;
Greater transparency of regulatory decision making and medical device information;
Close alignment with international best practice, and;
More flexible, responsive and proportionate regulation of medical devices.
Big News: New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders From the beginning of October 2021
Date of news: September 24, 2021
As per the EDQM website, from the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia monographs (CEPs) and CEP holders.
The news says that the communication with companies in the frame of their CEP applications will be streamlined, and e-mails or automatic notifications will be sent instead of letters in an increasing number of situations, such as reminders and acknowledgements of receipt of responses to deficiency letters and requests for revisions. Companies are therefore strongly advised to provide the DCEP with the name and valid e-mail address of a suitable contact person and to inform the DCEP whenever there are changes to this information.
This new tool will be used to ensure that documents related to CEP applications are shared securely. Applicants will no longer receive documents via e-mail but via the “EDQM DCEP Sharing tool”. Documents will be made available for download for 60 days maximum and will be deleted from the tool afterwards. Designated contact persons will receive a notification from the EDQM DCEP Sharing tool informing them of the automatic creation of their accounts and usernames and inviting them to choose a password. As indicated above, it is highly recommended to inform the DCEP immediately of any changes concerning the name or e-mail of the contact person.
The EDQM Database of Certificates of Suitability (CERTIFICATION Database) will display in real time the reasons why any CEPs are no longer valid (e.g. in case of suspension, withdrawal or expiry).
The implementation of this new IT tool may slow down CEP activities during the initial introductory phase.
Source: https://www.edqm.eu/
Pharma GMP News of the Week: 19-September-2021
Period: September 12, 2021 to September 18, 2021
MHRA launches public consultation on future of medical device regulation: People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.
Date of announcement: September 16, 2021
Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future.
ISPE published interesting article about Transportable Manufacturing on iSpeak Blog
Date on publishing: 13 September 2021
As per the article, “Transportable or Point of Care manufacturing is a capability that can be readily deployed temporarily in closer proximity to the patient base. This type of manufacturing can take various forms depending on the type of therapy and modality, and different solutions can be implemented depending on the scale and manufacturing requirements. Autonomous cleanroom PODs can be used for the larger footprint processes for clinical and commercial manufacturing. Customized trailers can be utilized for low volume manufacturing or labs as well as for some specific commercial applications. Portable, self-contained process skids can be placed either in a building or potentially on a truck, boat, or airplane. And the ultimate in future portability, suitcase manufacturing, can produce individual doses on demand in the field.”
Source: ispe.org
ISPE published article about Reverse Logistics Planning Can Save Time, Money, and Effort on iSpeak Blog
Date on publishing: September 16, 2021
As per the article “Reverse logistics is the process of planning, implementing, and controlling the efficient and effective inbound flow and storage of secondary goods and related information for the purpose of recovering value or proper disposal. Within the Investigational Product’s Supply Chain, it is an essential element more commonly referred to as the Returns Reconciliation, and Destruction Process.”
Source: ispe.org
ICH published Report of 2021 Implementation Survey on the ICH website on 17 September 2021
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. In support of this effort, an ICH-driven independent third party survey was conducted in 2021, building on the previous 2019 assessment. The main objective of this survey was to assist the ICH MC in determining whether the Regulatory Members would meet the eligibility criteria for the recent ICH MC elections and to allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility.
The 2021 Implementation Survey Report and additional information can be found on the ICH Guideline Implementation webpage.
Source: ICH.org
FDA update on Q2B Validation of Analytical Procedures
On September 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1). This guidance consists of the previously published FDA guidances, Q2A and Q2B. It is the same, in substance, as those two guidances, and it is the same, in substance, as the November 2005 ICH Q2(R1) guideline.
FDA released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)
Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”
Date of release: September 17, 2021
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
This draft guidance document revises the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018 to retain appropriate Q&As in draft.
Download Guideline: https://www.fda.gov/media/119278/download
FDA published final Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
Date of release: September 17, 2021
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
Download Guideline: https://www.fda.gov/media/119258/download
Pharma GMP News of the Week: 12-September-2021
Period: September 4, 2021 to September 11, 2021
U.S. Food and Drug Administration, published Notice on reopening of the comment period for ICH Q12 on post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.
The extension was proposed by Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA)
The FDA announced on 8 September Federal Register that “reopening the comment period for an additional 30 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying agency decision-making on these important issues.”
Source: Federal Register announcement, Request for extension by PhRMA
U.S. FDA updated guideline “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, Guidance for Industry, April 2021”
The guideline updated on September 8, 2021
As per the FDA, this guidance is issued to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.
Source: https://www.fda.gov/media/147355/download
MHRA has updated guidance on “Access to Electronic Health Records by Sponsor representatives in clinical trials”
The guideline updated on September 8, 2021
The guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
The data collected and analysed during clinical trials are verified and overseen by clinical trial Sponsors via representatives such as Clinical Research Associates (CRAs) or monitors. They will review the medical records to ensure that they match the data collected by the Sponsor, via Source Data Verification (SDV). The trial participants consent to this access of their medical records in writing, as part of the consent to take part in the clinical trial.
Increasingly, medical records are now electronic (Electronic Health Records; EHRs) and this poses the following challenges:
● direct access by the monitor/CRA to these records
● ensuring that access is restricted to only those participants in the trial
● ensuring that records of patients not in the trial, but maintained on the same system, are not accessed by the monitor/CRA
Healthcare Distribution Alliance (HDA) urges the US Food and Drug Administration (FDA) to immediately withdraw its guidance on electronic tracing
The guidance was published to build the electronic, interoperable systems called for in the Drug Supply Chain Security Act (DSCSA), scheduled for implementation on 27 November 2023.
As per the letter from HAD “The enhanced system seemingly contemplated by FDA would pose unacceptable security and compliance risks.” They also described that “We have serious concerns with the Draft Guidance’s assumption that trading partners will open up their proprietary systems for a direct connection with a government authority or with other trading partners. We do not see wholesale distributors or any other trading partners allowing federal or state government officials or other third parties direct, system-to-system connections to their records of every prescription drug product transaction in the U.S. pharmaceutical supply chain.”
Source: HDA comment, McKesson comment
Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6
At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021.
This addition to section 2.1. Apparatus fills a long-standing gap by setting out clear requirements for a piece of equipment that is the cornerstone of every analytical procedure described in the Ph. Eur. Weighing is one of the most common but also most critical tasks in a laboratory, as even the smallest weighing error can propagate throughout the whole analysis, affecting the accuracy of reported results.
This new general chapter complements existing guidelines for the use and qualification of balances published elsewhere. The principles outlined in it apply to all weighings performed as part of analytical procedures prescribed to establish compliance with a Ph. Eur. text. It is supplemented by the instructions related to “Quantities” given in the recently revised General Notices chapter, which is due to be published in Supplement 10.7 and which now includes a reference to this new chapter.
Rich Dad Poor Dad: What the Rich Teach Their Kids About Money That the Poor and Middle Class Do Not!
Pharma GMP News of the Week: 05-September-2021
Period: August 29, 2021 to September 04, 2021
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
Date of release: August 30, 2021
FDA recognizes that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial participants become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.
FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 public health control measures.
FDA outlines the following general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.
A. Considerations for ongoing trials:
B. In general, and if policies and procedures are not already in place for applicable trials:
C. For all trials that are impacted by the COVID-19 public health emergency:
The appendix further explains those general considerations by providing about 28 answers to questions about conducting clinical trials that the Agency has received during the COVID-19 public health emergency.
Source: FDA.gov
The European Commission seeks stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
The Commission Implementing Regulation (IR) on the performance of pharmacovigilance activities was adopted in 2012. It outlines the practical details to be respected by marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA).
As part of the Pharmaceutical Strategy for Europe, the Commission is not only committed to evaluate and review the general pharmaceutical legislation, but also to update and optimise existing implementing measures like the IR. The overall experience with the IR is good. However, following consultation with the EMA and the Pharmacovigilance Risk Assessment Committee, the need for some targeted amendments has been identified to take account of the experience gained and to update certain provisions in view of new technical standards being applied. The aim of this consultation is to inform and consult on those amendments. They focus on the following sections of the IR:
Chapter I – Pharmacovigilance system master file,
Chapter III – Minimum requirements for the monitoring of data in the Eudravigilance database,
Chapter IV – Use of terminology, formats and standards,
Chapter V – Transmission of suspected adverse reactions,
Chapter VIII – Post-authorisation safety studies.
While this consultation primarily seeks the stakeholders’ feedback on those proposed amendments, the Commission welcomes any additional remarks that could improve the application of the IR.
Source: https://ec.europa.eu/health/human-use/consultations/amendments-regulation520-2012_en
Revised guidance for electronic submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use (eCTD or VNeeS format), the European Directorate for the Quality of Medicines & HealthCare (EDQM) document “Guidance for electronic submissions for Certificates of Suitability (CEP) applications” (PA/PHCEP (09) 108) has been updated to reflect the current practices to facilitate submissions for applicants.
An important update is that when switching to the eCTD format from another format, it will be mandatory to include any information already assessed and approved previously in a “baseline (full dossier)” to facilitate the lifecycle management of the dossier. This will be implemented at the latest in January 2022. Applicants are invited to do so as soon as possible, however. In addition, based on applicants’ feedback, a number of clarifications are given for specific topics such as the submission of grouped revisions and examples of format issues hindering the receipt of applications.
Source: https://www.edqm.eu/
Blog post on MHRA site about “MHRA and US FDA tackle challenging data integrity”
The second Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) joint Good Clinical Practice (GCP) symposium was held in London in February 2020, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs.
Paper is published around emerging trends and compliance issues as the COVID-19 pandemic evolved, and the paper evolved with it. The paper discusses both agencies’ considerations on data integrity topics, from decentralised clinical trials, adaptive design trials and management of protocol deviations to real-world data. It was great working on this with our FDA colleagues and keeping up with them throughout the pandemic. The paper was published with the hope to provides a useful insight to readers.
Source: https://mhrainspectorate.blog.gov.uk/2021/09/01/mhra-and-us-fda-tackle-challenging-data-integrity/
Pharma GMP News of the Week: 22-August-2021
Period: August 15, 2021 to August 21, 2021
FDA published revised draft guideline on “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry”
Date of publishing: August 20, 2021
As per the agency, the purpose of revised draft is to clarify the agency’s recommendations regarding BE information submitted in an ANDA submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.
The new revision updated a draft originally published in the month of December 2013.
Source: https://www.fda.gov
ICMRA released paper on Artificial intelligence in medicine regulation
Month of release: August 2021
The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.
AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are increasingly being applied across all stages of a medicine’s lifecycle: from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimisation. This range of applications brings with it regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of AI failures and the wider impact these would have on AI uptake in medicine development and patients’ health.
Source: https://www.ema.europa.eu/
Pharma GMP News of the Week: 8-August-2021
Period: August 1, 2021 to August 7, 2021
US FDA published guideline on “Development and Submission of Near Infrared Analytical Procedures Guidance for Industry”
Date of publishing: August 6, 2021
This new guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products.
The guidance is applicable for new drug applications (NDAs), abbreviated new drug applications (ANDAs), Supplemental NDAs and ANDAs for small molecule drugs, and Drug substances and drug products covered in Type II drug master files. Scope of biological products will be added in future revision to this guidance.
The guidance is complementary to the PAT guidance published by FDA in September 2004.
The guidance’s concepts of validation can be applied to other process analytical technologies (PATs), including, for example, Raman, focused beam reflection measurement, particle imaging, and X-ray.
This guidance addresses the NIR-specific features that are not addressed in ICH Q2(R1). NIR analytical procedures typically combine the following features:
• Instrumentation elements (e.g., an analyzer consisting of an NIR spectrophotometer, a reflectance or transmission probe, or spectral analysis software)
• Acquisition parameters
• A sample presentation (interface)
• A sampling scheme for process applications
• The composition of spectral datasets
• Spectral pretreatments
• Wavelength ranges
• A chemometric model
For NIR-based process analyzers, Off-line, At-line, On-line, or In-line modes of measurement are commonly used.
The guideline provides detailed information about an application submission. Because of the unique characteristics and complexity of NIR procedures, as compared to conventional analytical procedures, FDA also provided detailed recommendations for reporting post-approval changes to NIR procedures.
Source: https://www.fda.gov/
MHRA updated a guide to defective medicinal products after 16 years
Month of publishing: August 2021
This guidance is on defective medicines and substances used in their manufacture or packaging which may also be defective. The earlier version of the guide was published in 2005.
The changes are made to reflect the UK’s departure from the European Union.
The document provides guidance to the pharmaceutical industry on handling and investigating suspected quality defects. It also gives details of both, the legal requirements and the
MHRA expectations with regard to product quality related complaints, investigations and recalls.
MHRA has updated its approach to risk classification. It uses National Patient Safety Alert (NatPSA) for defects where Class 1 represents a risk of death or disability. Class 2, 3 and 4 are to categorize lower-risk defects.
Source: https://assets.publishing.service.gov.uk
Survey of Notified Bodies on Remote Audits: Successful or Unsuccessful?
The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB). Out of 52 requests, 46 had participated in the survey with a total of more than 33,000 audit days. The answer to the question “What is your experience with remote audits?” was 90% successful and 10% generally unsuccessful.
Sharing experience is categorized below:
| Successful | Unsuccessful |
| Decreases travel time and cost | Issues when there is a large time difference |
| Tight focus | Issues with internet connections |
| Easier to take notes | Video does not permit to see and look for as if we were onsite |
| Very effective for non-physical processes (like software) and pure QMS aspects | Generally, the spontaneousness of auditing, i.e. reacting immediately to an issue/sample picking |
| The verification of the quality of records is more accurate than in an onsite audit | |
| Remote audits are more successful with established customers |
Download useful information:
Source: team-nb.org
FDA grants industry 30-day extension to comment on track and trace guidance under the Drug Supply Chain Security Act (DSCSA)
The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain.
The Pharmaceutical Distribution Security Alliance (PDSA) and the Healthcare Distribution Alliance (HDA) made request for extension.
Source:
Federal Register
PDSA request for extension
HDA request for extension
Registration open for 2021 Seminar on “GMP Assessment Approaches in Post COVID-19 Era”
Date of announcement: August 2, 2021
Deadline for registration: October 3, 2021.
Seminar will be hosted virtually from 9-11 November 2021 are now open (for Medicines Regulatory Authorities only).
The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is pleased to announce that the 2021 PIC/S Virtual Seminar will be hosted by MFDS from 9 to 11 November 2021.
The Seminar on “GMP Assessment Approaches in Post COVID-19 Era” will consist of presentations, interactive panel discussions, and workshops for GMP Inspectors from around the world.
As the COVID-19 pandemic has put restrictions on GMP on-site inspections, various alternative GMP assessment approaches have been taken by regulatory authorities to ensure the quality of pharmaceuticals. As we face the post COVID-19 era, there is a need to explore the current and future status of these GMP assessment approaches. There is also a need to be prepared for the changes that will likely be seen in post COVID-19. Therefore, in this Seminar, we look forward to valuable presentations and discussions regarding different experiences in distant assessment from regulatory and industry experts; and regarding the status of GMP assessment based on reliance.
The Seminar is open to the participation of Inspectors from medicines regulatory authorities around the world.
For more information, please contact the PIC/S Secretariat.
Source: https://picscheme.org/
Pharma GMP News of the Week: 1-August-2021
Period: July 25, 2021 to July 31, 2021
EMA published “Guideline on quality documentation for medicinal products when used with a medical device, dated 22 July 2021”
Month of publishing: July 2021
This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004.
This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.
This guideline applies in the following cases:
• Medicinal products where the medical device and/or device part and the medicinal product form an integral product that is not reusable (hereafter called integral) and where the action of the medicinal product is principal,
• Medicinal products placed on the market by the Marketing Authorisation Holder (MAH), where the medical device is packed together with the medicinal product (hereafter called co-packaged), or
• Medicinal products, where the product information refers to a specific medical device to be used with the medicinal product, and the medical device is obtained separately by the user of the medicinal product (hereafter called referenced).
Source: https://www.ema.europa.eu
EMA released “Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development” dated July 26, 2021
Date of publishing: July 26, 2021
This reflection paper identifies specific areas where the quantitative comparative evaluation of drug product quality characteristics plays an important role from the regulatory perspective. This might involve decision making processes potentially leading to marketing authorisation as well as postauthorisation decisions during drug lifecycle.
The document focusses on methodological aspects in relation to statistical data comparison approaches for pre- and post-manufacturing changes, biosimilar development, and generics’ development.
The reflection paper raises open issues from a statistical perspective, and addresses questions related to comparison objectives, sampling strategies, sources of variability and options (or limitations) for statistical inference
This document is targeted at both experts from industry and regulatory assessors. This reflection paper complements other available regulatory guidance where comparative data assessment of quality attributes is discussed for certain contexts, but also provides more detailed guidance of how to actually carry out the comparison task based on empirical sample data.
The guideline also provides protocol requirements for Quality Attributes data comparison.
The International Council for Harmonisation (ICH) on July 27, 2021 issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.
Date of publishing: July 27, 2021
The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process on 27 July 2021 and now enters the public consultation period.
This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products. The principles described in this guideline may also apply to other biological/biotechnological entities.
Three different models of continuous manufacturing are described in the draft guideline:
o one includes a combination of approaches in which some unit operations operate in a batch mode while others operate in a continuous mode;
o second is where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous mode;
o third is an approach in which the drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process.
FDA has been encouraging continuous manufacturing for the past decade as a way to improve product quality, minimize product defects, and reduce drug shortages, promoting it as a more efficient process than the more antiquated batch production process. There are 10 approved continuous manufacturing applications in the US, including original applications and supplements.
Source: https://www.ich.org
Food and Drug Administration announced revised Generic Drug User Fee Rates for Fiscal Year 2022 on Jul 28, 2021
Date of publishing: July 28, 2021
The GDUFA fees for FY 2022 announced on the Federal Register pre-publication page. The new fees will be applicable for all submissions submitted on or after October 1, 2021. The FY 2022 fees with a comparison to the FY 2021 fees is provides in the table below.
| Fee category | Fees rates for FY 2021 | Fees rates for FY 2022 | % Change |
| Applications: | |||
| Abbreviated New Drug Application (ANDA) | 196,868 | 225,712 | 14.65 |
| Drug Master File (DMF) | 69,921 | 74,952 | 7.20 |
| Facilities: | |||
| Active Pharmaceutical Ingredient (API)—Domestic | 41,671 | 42,557 | 2.13 |
| API—Foreign | 56,671 | 57,557 | 1.56 |
| Finished Dosage Form (FDF)—Domestic | 184,022 | 195,012 | 5.97 |
| FDF—Foreign | 199,022 | 210,012 | 5.52 |
| Contract Manufacturing Organization (CMO)—Domestic | 61,341 | 65,004 | 5.97 |
| CMO—Foreign | 76,341 | 80,004 | 4.80 |
| GDUFA Program: | |||
| Large size operation generic drug applicant: >20 ANDAs | 1,542,993 | 1,536,856 | -0.40 |
| Medium size operation generic drug applicant: 6-19 ANDAs | 617,197 | 614,742 | -0.40 |
| Small business operation generic drug applicant: 5 or less ANDAs | 154,299 | 153,686 | -0.40 |
The European Medicines Agency (EMA) on Jul 29, 2021 issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.
Date of publishing: July 29, 2021
The Reflection Paper concerns the responsibilities and activities of MAHs with respect to the European Commission’s Guide to GMP (Parts I, II, and its relevant Annexes) for medicines for human and veterinary use. It also covers the responsibilities of MAHs and Sponsors (where the Sponsor is different from the MAH) with regard to the handling of quality defects with investigational medicinal products.
The scope also extends to certain legislative provisions that have relevance to GMP, such as those stated in the GMP Directives 2003/94/EC and 91/412/EC (as amended), as well as relevant articles in Directive 2001/83/EC and Regulation (EU) 2019/6.
It also applies to holders of Registration and Traditional-use Registrations for herbal/homeopathic medicinal products.
FMD: The relevant provisions of the Falsified Medicines Directive 2011/62/EU and the related Delegated Regulations (including the Safety Features Regulation 2016/161) are also within scope of this Reflection Paper.
ATMP: The reflection paper does not cover some of the advanced therapy medicinal product (ATMP) GMP requirements that are addressed in Part IV of the GMP guide.
GDP Responsibilities: While this Reflection Paper is not intended to address the GDP-related responsibilities that may apply to MAHs, it is considered important to highlight here that MAHs do need to understand the type of interfaces that may need to be in place with the wholesalers they employ or engage.
The main points include:
• Outsourcing and Technical Agreements
• Audits and Qualification Activities
• Communication with Manufacturing Sites (e.g. MA Dossier Information, Variations, Regulatory
Commitments, etc.)
• Product Quality Reviews
• Quality Defects, Complaints and Product Recalls
• Maintenance of Supply of Medicinal Products
• Continual Improvement Activities
Source: https://www.ema.europa.eu
Pharma GMP News of the Week: 25-July-2021
Period: July 18, 2021 to July 24, 2021
FDA has issued Field Alert Report Submission: Questions and Answers Guidance for Industry
Docket Number: FDA-2018-D-2326
Month of publishing: July 2021
The guidance is issued by: Office of Regulatory Affairs, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.
The question includes following main questions as well other subtopics within these questions.
1. What is a FAR and what triggers its submission?
2. Who is responsible for submitting the FAR?
3. When should I submit a FAR?
4. How do I submit a FAR?
5. Where do I submit a FAR? 6. Should I submit a follow-up or final FAR?
Source: fda.gov
FDA has issued Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations):
Docket Number: FDA-2020-D-1456
Month of publishing: July 2021
The guidance is issued by: Center for Food Safety and Applied Nutrition, Office of Food Additive Safety
The purpose of this document is to highlight the chemistry issues that FDA recommends that a manufacturer of recycled plastic consider during the manufacturer’s evaluation of a recycling process for producing material suitable for food-contact applications.
This document supersedes the December 1992 “Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations” (1992 “Points to Consider”). The possibility that chemical contaminants in plastic materials intended for recycling may remain in the recycled material and could migrate into the food the material contacts is one of the major considerations for the safe use of recycled plastics for food-contact applications. Other aspects of plastics recycling, such as microbial contamination and structural integrity of the recycled plastic, are also important, but are not discussed in this document.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. This guidance was revised to include Paperwork Reduction Act information, containing non-substantive formatting or editorial revisions to the guidance, which was originally issued in August 2006. Revisions are noted by date at the end of the guidance.
Source: fda.gov
Revision of USP <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy – Theory and Practice
This proposal is based on the version of the monograph official as of January 1, 2020. The proposed revisions, which are in response to stakeholder comments and questions, include the following:
- Clarify that the scope of the chapter does not apply to multichannel plate readers.
- Remove the Xe line reference in Table 2 for control of wavelength by atomic line spectra.
- Remove the Control of Photometric Response section as demonstrating absorbance accuracy over its intended operational range assures proper photometric response.
- Revise for clarity the requirements and procedures for Control of Absorbance, including procedures for absorbance accuracy and precision.
- Clarify the equation in Procedure A for the Estimation of the Limit of Stray Light as determined from the differential absorbance spectrum.
- Replace the term “cell” with “cuvette” throughout.
Further revisions to include appropriate standards for chromatographic detectors and multichannel plate readers are under discussion and may be proposed at a later date.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
The draft chapter <857> Ultraviolet-Visible Spectroscopy can be viewed here. (Note: a registration is required to access the Pharmacopeial Forum.)
Source: https://online.usppf.com
Revision of USP <1857> Ultraviolet-Visible Spectroscopy—Theory and Practice
Revision of the chapter includes:
- Changes done in the chapter in line with 〈857〉 Ultraviolet-Visible Spectroscopy
- Multichannel plate reader systems excluded from this chapter
- Replace the term “cell” with “cuvette” throughout.
- Text for Control of absorbance revised as: To establish adequate accuracy, precision, and photometric performance of a given system, it is necessary to verify the absorbance accuracy of a system over its intended operational range by selection and use of the following procedures as appropriate for the wavelength and absorbance ranges required. Demonstrating absorbance accuracy over the system’s intended operational range assures proper photometric response.
- Table 4 “Available CRMs for the Control of Absorbance” revised
The draft chapter <1857> Ultraviolet-Visible Spectroscopy – Theory and Practice is available to refer at this link.
Pharma GMP News of the Week: 18-July-2021
Period: July 11, 2021 to July 17, 2021
WHO has released draft guideline on Good Manufacturing Practices for investigational products:
Document Number: Working document QAS/20.863/Rev1
Month of publishing: July 2021
World Health Organization (WHO) Prequalification Team – Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans. The Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) concurred with this proposal.
The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles from other related international guidelines. Investigational products are used for testing purposes; as a reference in clinical trials and field trials; as a placebo; for an unauthorized indication; and to gain further information about the authorized form. In some cases, marketed products which have been re-packaged or modified in some way, are used for investigational purposes.
Source: WHO guideline
PICS released guideline on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1)
Document Number: PI 055-1
Date of publishing: 15 July 2021
On 15 July 2021, PIC/S announced adoption of guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1). This guidance for inspectorates, which has been prepared by the PIC/S Working Group on Inspectors
Risk Assessment covers announced GXP inspection of national sites. This needs to be completed during the inspection planning phase, in consultation with the site to be inspected, prior to the inspection taking place. The site must confirm that the necessary measures identified in the risk assessment will be implemented Consideration should also be given to Covid testing of Inspectors / Investigators pre and post inspection and may be requested by some sites.
Source: https://picscheme.org/
PICS released guideline on “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management” (PI 054-1)
Document Number: PI 054-1
Date of publishing: 15 July 2021
This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide – PQS effectiveness and the management of changes. It provides practical guidance for GMP Inspectors in these areas, and the implementation of that guidance has the potential to ultimately lead to the more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation. This serves the interest of patients and animals.
In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 – the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.
The guideline also covered important aspects and examples of Change Review and effectiveness review with headings “Prior to change closure” and “Prior to or after change closure”.
Source: https://picscheme.org/
WHO has released draft guideline on WHO good practices for research and development facilities of pharmaceutical products:
Document Number: Working document QAS/20.865/.Rev1
Month of publishing: July 2021
In view of the need for the development of health products, including the research and development for the treatment of COVID-19 therapies, the World Health Organization (WHO) Prequalification Inspection Services Team (PQT INS) raised the urgency for the development of life cycle appropriate good practices text to address the manufacturing of developmental batches, pilot batches and the sequential stability data that are submitted in product applications (dossiers) for marketing authorization and the prequalification of medical products.
There is currently no other specific WHO guideline which addresses this matter. The data collected from these batches influence the aspects of the product i.e. stability; process validation; and analytical method development and validation.
This guideline is specifically applicable to research and development facilities of pharmaceutical products procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, validation, quality control laboratory activities such as stability testing and development, and validation of cleaning procedures.
The main focus of this document is to provide for GxP in the production and control of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities, where these are directly supporting; for example, shelf life claims, animal studies or validation activities. The principles described in this document may be applied in facilities where other products, such biopharmaceutical products, vaccines and medical devices, are manufactured.
Source: WHO guideline
Implementation of the European Pharmacopoeia Supplement 10.6 and Notification for CEP holders to update their applications according to the revised monographs
Date of announcement: July 13, 2021
Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below.
According to Directives 2001/83/EC and 2001/82/EC, as amended, it is the responsibility of the manufacturer to comply with the current version of a Ph. Eur. monograph, and therefore to update the specification when a revised monograph is issued. In addition, the European Directorate for the Quality of Medicines and HealthCare (EDQM) ensures that CEPs refer to the most recent version of a Ph. Eur. monograph at any time.
Source: https://www.edqm.eu/en/news/implementation-european-pharmacopoeia-supplement-106-notification-cep-holders
CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3
Date of announcement: July 15, 2021
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The lists of the substances affected by these revisions and for which CEPs have been granted.
Users can register for free for the access to Pharmeuropa on the EDQM website Pharmeuropa, Pharmeuropa Bio & Scientific Notes.
Source: https://www.edqm.eu/en/news/cep-holders-invited-comment-draft-monographs-published-pharmeuropa-333
Pharma GMP News of the Week: 11-July-2021
Period: July 1, 2021 to July 10, 2021
Data Integrity Document published by PIC/S: 1 July 2021
Name of Guideline: PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments
There are 14 chapters in the guideline. The document covers important aspects of Data governance system, Organisational influences on successful data integrity management, General data integrity principles and enablers, Specific data integrity considerations for paper-based systems, Specific data integrity considerations for computerised systems, Data integrity considerations for outsourced activities.
Most importantly, it also covered what would be the Regulatory actions in response to data integrity findings and how to remediate the situation of data integrity failures.
Key Points in the guideline:
- Discussed about all activities related to the handling of data, data policy, documentation, quality and security.
- Data management related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The scope also covers documents related to registration dossier.
- On-site and remote, or desktop, inspections.
- The concept of the data lifecycle, starts from data generation, processing, reporting, checking, data used for decision-making, storage and disposal at the end of the retention period.
- Data governance controls.
- Company culture and its integration with data integrity plan.
- Approach regarding non-hierarchic management structure and top-down structure.
- General data integrity principles and “enablers” that help put the principles into operation.
- ALCOA and ALCOA++ for both, paper and electronic systems.
- Specific elements checking during a record review, and expectations for generation, distribution and control of records.
- Expectations and potential risks in qualifying computer systems.
- System security issues such as user access controls.
- Data integrity within hybrid systems.
- Hybrid systems are discourages to use because of their complexity and potential increased vulnerability to manipulation of data.
- Data integrity related to outsourcing activities.
- Potential regulatory actions that may be taken in response to deficiencies or other data integrity findings.
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry issued by US FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research: July 2021
This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).
Source: www.fda.gov
Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa: July 2021
The revised general chapter Chemometric methods applied to analytical data (5.21) has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum, for comment. The deadline for comments is 30 September 2021.
This general chapter, published for information, is an introduction to the use of chemometrics and data science techniques. The objective is to provide indications on good practice and requirements for the processing of analytical data.
The chapter is rewritten. Key point includes:
- Updated Section 1. General aspects with a review of parts on Pre-processing (1.2.2.6) and Assessment and validation of chemometric methods (1.3);
- New subsections added:
- Independent component analysis (2.2)
- Decision trees and random forests (2.6);
- Review of sub-sections on:
- Similarity measures (2.3)
- Clustering (2.5)
- Multiple linear regression (2.8)
- Principal component regression (2.9)
- Support vector machines for supervised classification (2.11)
- Artificial neural networks (2.12);
- New section added:
- 3. Related application fields, covering sub-sections on Chemometrics in chemical imaging (3.1)
- Data fusion (3.2);
Pharmeuropa 33.3 released: 05 July 2021
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation.
The deadline for comments on Pharmeuropa 33.3 is 30 September 2021.
Source: https://www.edqm.eu/en/news/pharmeuropa-333-just-released
Cleaning validation guide (GUI-0028) revised by Health Canada: Published on June 29, 2021
This document provides guidance on cleaning validation. It will help user to understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations).
This guide addresses special considerations and issues when validating cleaning procedures for equipment used to fabricate and package of Active Pharmaceutical Ingredients (APIs), Pharmaceuticals,
Radiopharmaceuticals, Biological drugs, and Veterinary drugs.
It covers validation of equipment cleaning for the removal of residues associated with products used in the previous production run, such as active ingredients, breakdown or by-products of concern, intermediates, residues of cleaning agents, and processing agents the control of potential microbial contaminants
