GMP News

Latest Pharma GMP News and Regulatory updates

Latest Pharma GMP News and Regulatory Updates 1

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAzNzc=

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.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-qas-external-guidance-policy-0070-clinical-data-publication-cdp_en.pdf

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.

Source: https://www.fda.gov.ph/draft-for-comments-application-process-and-requirements-for-post-approval-changes-of-biological-products-adopting-the-world-health-organization-guidelines-for-changes-to-approved-vaccines-and-bioth/

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.

Source: https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework

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:

https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics

https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses

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.

Source: https://pharmaceuticals.gov.in/sites/default/files/Gazette%20Notification%20%20R%26D%20Policy%20-%20Dated%2018%20Aug%2023.pdf

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:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0?utm_medium=email&utm_source=govdelivery

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act?utm_medium=email&utm_source=govdelivery

 

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.

Source: https://www.tga.gov.au/news/news/product-information-inserts-are-no-longer-required-injectable-medicines-administered-health-professionals

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.

Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1182091/MHRA_GPvP_inspection_metrics_2021-22.pdf

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.

Source: https://www.gov.uk/government/publications/mhra-corporate-plan-2023-to-2026/medicines-and-healthcare-products-regulatory-agency-business-plan-2023-to-2024

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.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selecting-predicate-device-support-premarket-notification-510k-submission

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.

Source: https://www.medicinesforeurope.com/wp-content/uploads/2023/09/Medicines-for-Europe-gears-up-for-Ukraine.pdf

https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-working-with-ukraine-on-eu-accession-and-medicines-and-vaccines-regulatory-alignment-and-patient-safety-issues/

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.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-peptide-drug-products

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.

Source: https://www.medtecheurope.org/resource-library/open-letter-to-commissioner-for-health-stella-kyriakides-need-for-comprehensive-structural-reforms-of-the-medical-technology-regulatory-frameworks/

https://www.medtecheurope.org/wp-content/uploads/2023/09/medtech-europe_open-letter-to-commissioner-kyriakides.pdf

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.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fostering-medical-device-improvement-fda-activities-and-engagement-voluntary-improvement-program

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.

Source: https://www.federalregister.gov/documents/2023/09/15/2023-20015/quality-management-maturity-program-for-drug-manufacturing-establishments-establishment-of-a-public

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.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-based-one-adequate-and-well-controlled-clinical

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.

Source: https://www.imdrf.org/sites/default/files/2023-09/IMDRF_PMD%20WG_N58%20FINAL_2023%20%28Edition%202%29_0.pdf

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

https://www.gov.uk/government/news/uk-patients-set-to-have-faster-access-to-innovative-medical-technologies-via-new-pathway

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.

Source: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/biologicals/questions-answers-biological-medicinal-products

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.

Source:  https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies

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).

Source: https://npra.gov.my/index.php/en/directive-general/91-directive-prescriptions/1527503-pekeliling-berkenaan-kawalan-impuriti-nitrosamines-dalam-produk-farmaseutikal.html

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.

Source: https://www.fda.gov/medical-devices/industry-medical-devices/electronic-export-documents-letter-industry

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.

Source: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf

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.

Source: https://www.reach.gov.sg/Participate/Public-Consultation/Health-Sciences-Authority/public-consultation-on-the-proposed-regulation-for-active-ingredients-under-the-health-products-act

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.

Source: https://www.who.int/news-room/articles-detail/public-consultation-on-who-guidance-for-best-practices-for-clinical-trials

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.

Source: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers#questions-and-answers-on-remote-batch-certification-/-confirmation-by-the-qualified-person-(qp)—new-july-2023-section

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.

Source: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization

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.

Source: https://consultations.tga.gov.au/medical-devices-and-product-quality-division/public-consultation-application-audit/

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.

Source: https://www.fda.gov/drugs/news-events-human-drugs/cder-collaborates-global-regulators-pharmaceutical-quality-assessments-and-inspections?utm_medium=email&utm_source=govdelivery

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:   

Source: https://www.edqm.eu/en/-/093-news-requirements-for-the-content-of-the-cep-dossier-according-to-the-cep-2.0-and-updated-application-forms. 

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

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).

Source: Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials 

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.

Source: https://www.edqm.eu/en/-/ph.-eur.-commission-kicks-off-elaboration-of-three-general-texts-on-mrna-vaccines-and-components 

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. 

Source: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0023-guide-to-reporting-and-investigation-of-quality-defects-in-medicinal-products-for-human-and-veterinary-use-v8.pdf?sfvrsn=43 

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.

Source: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf#full-publication-update-history 

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 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

2. Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations 

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.

Source: https://www.pmda.go.jp/review-services/trials/0011.html?utm_campaign=LinkedIn%202023&utm_content=243745573&utm_medium=social&utm_source=linkedin&hss_channel=lcp-5136289

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. 

Source: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

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. 

Source: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints For 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.

Source: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

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.

Source: Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023 – European Directorate for the Quality of Medicines & HealthCare 

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).

Source:  Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2 – European Directorate for the Quality of Medicines & HealthCare 

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

Source:  Regulatory information – adjusted fees for applications to EMA from 1 April 2023 | European Medicines Agency

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.

Source: CEP 2.0 – Public consultation: CEP letter of access – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years – GOV.UK 

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.

Source:  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf 

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.

Source: https://www.edqm.eu/en/-/remote-and-online-provision-of-medicines-edqm-targeted-stakeholder-consultation 

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.

Source: https://www.fda.gov/media/166156/download

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: 

  1. Questions and Answers: political agreement in principle on the Windsor Framework, a new way forwardfor the Protocol on Ireland / Northern Ireland
  2. 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.

Source: https://www.edqm.eu/en/-/pharmacopoeial-discussion-group-achievements-sign-off-on-harmonisation-texts 

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.

Source: https://www.edqm.eu/en/-/european-pharmacopoeia-commission-creates-new-excipients-strategy-working-party  

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.

Source: Response template for applicants – GOV.UK

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).

Source: Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)

US FDA Center for Devices and Radiological Health published six final guidelines 

Date of news: February 21, 2023

Guideline NameLink
Guidance for Industry and Food and Drug Administration Staff – Assembler’s Guide to Diagnostic X-Ray EquipmentPDF 
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance GuidePDF
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration StaffPDF
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration StaffPDF
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration StaffPDF 
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration StaffPDF

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.

Source: https://www.edqm.eu/en/-/public-consultation-on-ph.-eur.-rabbit-pyrogen-test-replacement-texts-in-pharmeuropa-35.1 

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

Source: https://www.fda.gov/media/165468/download 

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..

Source: https://www.edqm.eu/en/-/ph.-eur.-commission-establishes-a-dedicated-working-party-on-high-throughput-sequencing 

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.

Source: Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act 

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

Source: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/update-person-face-face-formal-meetings-fda?utm_medium=email&utm_source=govdelivery 

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).

Source: CEP holders – How to submit a nitrosamine risk assessment – European Directorate for the Quality of Medicines & HealthCare

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.

Source: 30 January 2023, version 01 The rules governing medicinal products in the European Union VOLUME 10 – Guidance documents applyin

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.

Source: Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees – GOV.UK

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.

Source: SNOMED International and the EDQM collaborate on map development – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU 

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: 

  1. AIDE – MEMOIRE INSPECTION OF GOOD DISTRIBUTION PRACTICE (GDP) FOR MEDICINAL PRODUCTS IN THE SUPPLY CHAIN
  2. 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

Source: Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products 

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.

Source: A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies | European Medicines Agency 

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

Courses for Pharmaceutical Industry Professionals

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.

  1. It helps you to stay ahead in your field with the latest developments and best practices.
  2. Provides hands-on training and practical insights to improve your skills to become more effective in your job.
  3. 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 NameCourse Created byMinimum nos. of Participants have taken the courseCourse Rating (out of 5)
1Your Guide to the Pharmaceutical IndustryPhil Yates7,813+ students4.4
2Certificate Course in Drug Regulatory Affairs (DRA)Dr. Sachin Potawale4,541+ students4.1
3Basic Good Manufacturing Practices (GMP)Ruben Alonso2,264+ students4.2
4Medical Device Process Validation. ISO 13485. IQ OQ PQMartin Conneely2,035+ students4.4
5Medical Device Regulation 2017/745 EU regulatory affairsMartin Conneely1,835+ students4.6
6Practical Regulatory Affairs 2020 – European Medical DevicesPubudi Silva1,255+ students4.3
7The Pharmaceutical R&D Process in HealthcareJames Mitroka1,169+ students4.5
8Computerised System Validation (CSV)Hitendrakumar Shah1,102+ students3.9
9Medical Device RegulationsSequenceCentral – IT Training and Consulting1,242+ students4.1
10Master pharmaceutical quality management systemDr. Zahra Hassan336+ students4.2
11Certificate Course in Pharmaceutical Quality AssuranceAteos Foundation of Science Education and Research307+ students3.8
12How to audit GMP systemsRuben Alonso273+ students4.6
13Good Laboratory PracticesHitendrakumar Shah127+ students3.3
14Good Storage Practices for PharmaceuticalsHitendrakumar Shah36+ students4.4
15Job Oriented Certificate Course in PharmacovigilancePV Drug Safety Academy79+ students4.3
16Certificate Course in PharmacovigilanceSrikanth Gorantla1,144 students4.4
17Medical Writing for Healthcare ProfessionalsAlex Evans, PharmD, MBA1,971 students4.5
18Clinical Research for beginnersDr Sabyasachi Sengupta2,236 students4.1
19Complete Introduction to Google Data Studio 2023 EditionIan Littlejohn19,758 students4.6
20Google Sheets – The Comprehensive MasterclassLeila Gharani26,729 students4.8
21Statistical Process Control (SPC) Using Microsoft ExcelRay Harkins, The Manufacturing Academy5,273 students4.5

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Source: Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications | European Medicines Agency 

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

Source: EU Survey Targeted consultation on the implementation of the Clinical Trials Regulation (EU) No 536/2014 Factual summary report 

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.

Source: UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care – GOV.UK 

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

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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.

Source: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases 

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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 

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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.

Source: Federal Register :: Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products 

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

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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.

Source: MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 

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.

Source: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers 

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.

Source: Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Ph. Eur. Commission welcomes Ethiopian FDA as observer – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry 

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.

Source: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format 

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

Source: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12 January 2023 | European Medicines Agency

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTczNQ== 

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTY4NA==

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.

Source: https://www.fda.gov/media/164344/download

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.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m11-technical-specification-clinical-electronic-structured-harmonised-protocol

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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.

Source: European Paediatric Formulary: Chloral Hydrate Oral Solution monograph open for public consultation in Pharmeuropa PaedForm 

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

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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).

Source: https://www.edqm.eu/en/-/signal-to-noise-ratio-revision-of-ph.-eur.-general-chapter-chromatographic-separation-techniques-2.2.46- 

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.

Source: EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals

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.

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.311.01.0060.01.ENG&toc=OJ%3AL%3A2022%3A311%3ATOC#document1 

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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.

Source: Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programm 

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.

Source: How CEP holders can avoid the rejection of notifications – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clos

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

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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.

Source: https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en 

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

Source: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-november-1-december-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.

Source: https://admin.ich.org/sites/default/files/inline-files/ICH45_Incheon_Meeting_PressRelease_2022_1122_Final_0.pdf 

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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.

Source: https://pharmaceuticals.gov.in/sites/default/files/Drugs%20Prices%20Control%20Amendment%20Order%202022.pdf 

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).

Source: MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

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

Source: Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing – GOV.UK 

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.

Source: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act | FDA

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.

Source: https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2022-preventing-antimicrobial-resistance-together

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.

Source: Europe’s share of global medicines R&D shrinks by a quarter in 20 years – as sector’s declining trends continue 

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

Source: https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#full-publication-update-history 

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.

Source: Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin 

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.

Source: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Commun

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.

Source: https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en?filename=mdcg_202216_en.pdf 

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.

Source: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide Guidance for Industry

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.

Source: Regulatory update – EMA encourages companies to submit type I variations for 2022 by end of November | European Medicines Agency 

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.

Source: Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry 

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.

Source: https://www.fda.gov/media/162903/download

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).

Source: Implementation of the future regulation of medical devices and extension of standstill period – GOV.UK 

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.

Source: Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions – Guidance for Industry and Food an 

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).

Source: Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention 

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.

Source: Guidance on pharmacovigilance procedures – GOV.UK

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.

Source: Staff Working Document on Vulnerabilities of the global supply chains of medicines – Structured Dialogue on the security of medicines supply 

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.

Source: EDQM changes CEP policy regarding chemical applications for polymorphs – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care 

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.

Source: Draft Guidance for Industry: In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs 

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.

Source: https://www.edqm.eu/en/-/cep-holders-invited-to-comment-on-draft-monographs-published-in-pharmeuropa-34.4

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTExOQ==

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.

Source: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations 

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.

Source: Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety – GOV.UK 

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

Source: Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems – GOV.UK 

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).

Source: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA 

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.

  1. The most recent proof is less than three years old.
  2. 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.
  3. 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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw== 

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.

Source: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals 

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.

Source: Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: Guidance for Industry | Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA 

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.

Source: Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA 

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.

Source: Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia – European Directorate for the Quality of Medicines & HealthCare 

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA0MQ== 

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

Source: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials#full-publication-update-history 

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).

Source: https://www.gov.uk/government/news/mhra-appoints-first-new-uk-approved-body-to-certify-medical-devices-since-brexit 

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.

Source: https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-3-october-2022

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.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTAxMg==

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.

Source: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/potentielle-verunreinigungen-nitrosaminen-update.html 

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.

Source: https://www.medtecheurope.org/wp-content/uploads/2022/09/220919-reaction_juri-committee-vote_ai-act.pdf 

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.

Source: https://www.gov.uk/government/publications/the-northern-ireland-mhra-authorised-route-nimar/the-northern-ireland-mhra-authorised-route-nimar#advertising-and-promotions 

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.

Source: Electronic Submission Template for Medical Device 510(k) Submissions – Guidance for Industry and Food and Drug Administration Staff (fda.gov)

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

Source: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about/our-governance 

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. 

Source: 2019-89-DG- Ethical Consideratons for Clinical Investigations of Medical Products Involving Children (9-19-22).docx (fda.gov)

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.

Source: https://www.edqm.eu/en/-/indian-pharmacopoeia-commission-to-be-represented-at-edqm-international-conference-in-strasbourg 

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.

Source: https://www.federalregister.gov/documents/2022/09/13/2022-19713/alternative-or-streamlined-mechanisms-for-complying-with-the-current-good-manufacturing-practice 

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;

Source: https://www.fda.gov/media/148474/download

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.

  1. Active pharmaceutical ingredients manufacturers and importers registration: fees
  2. Active substance importers or distributors: fees
  3. Active substance manufacturers: fees
  4. Blood banks: application fees for a Review Panel hearing
  5. Blood banks and other blood establishments: fees
  6. Blood facilities: contract laboratories fees
  7. Broker registration fees
  8. Clinical trials: application fees
  9. Clinical investigations for devices: fees
  10. Drug-device combination products: fees
  11. Homoeopathic National Rules Scheme: fees
  12. Homeopathic National Rules Scheme: fees for inspections
  13. Inspection: fees
  14. Licence applications: marketing authorisation fees
  15. Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees
  16. Licence applications: parallel imports fees
  17. Licence applications: Phase 1 Accreditation Scheme fees
  18. Medicines export certificates: fees
  19. Periodic fees for holding a marketing authorisation
  20. Licence renewals, reclassifications and assessment of labels and leaflets: fees
  21. Orphan Marketing Products: fees
  22. Pharmacovigilance (PV) Safety Review: fees
  23. Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees
  24. Pre-Assessment (Rolling Review): fees
  25. Safety and quality vetting of unlicenced imported medicines fees
  26. Scientific advice meetings: fees
  27. Simplified Homeopathic Registration Scheme: fees
  28. Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees
  29. Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees
  30. Testing of samples: fees
  31. Traditional Herbal Registration Scheme: fees
  32. Variation: Homeopathic National Rules Scheme fees
  33. Variations: Homeopathic Simplified Scheme fees
  34. Variations: licence variations application fees
  35. Variations: licence variations applications groups fees
  36. Variations: other licence variations applications fees
  37. Variations: Traditional Herbal Registration Scheme fees
  38. Wholesale distribution authorisations: fees
  39. 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.

Source: https://www.edqm.eu/en/-/new-faq-on-edqm-helpdesk-ph.-eur.-revised-general-chapter-2.2.46.-chromatographic-separation-techniques-1 

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

Source: https://www.gov.uk/government/consultations/consultation-on-a-new-code-of-practice-for-the-expert-advisory-committees/outcome/summary-of-responses-to-consultation-new-code-of-practice-for-the-expert-advisory-committees 

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.

Source: https://www.gov.uk/government/news/mhra-launches-new-conflicts-of-interest-code-of-practice-for-independent-advisors 

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

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html 

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.

Source: https://www.edqm.eu/en/-/ph.-eur.-survey-for-the-availability-of-alternative-plasticisers-to-dehp-in-containers-for-aqueous-solutions-for-intravenous-infusion-in-authorised-medicinal-products 

Blog published by MHRA “Innovation, Quality & Transparency – a Compliance Team 1 Perspective”

Date of news: August  23, 2022

Source: https://mhrainspectorate.blog.gov.uk/2022/08/23/innovation-quality-transparency-a-compliance-team-1-perspective/ 

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.

Source: https://www.fda.gov/media/161190/download

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. 

Source: https://www.tga.gov.au/consultation/consultation-2022-2023-proposed-changes-permissible-ingredients-determination-low-negligible-risk 

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.

Source: https://www.edqm.eu/en/-/nitrosamines-deadline-extension-to-all-cep-holders-to-complete-step-3-revision-to-the-cep-now-1st-october-2023-.

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.

Source: https://www.edqm.eu/en/-/general-chapter-2.2.46.-chromatographic-separation-techniques-now-published-in-ph.-eur.-11th-edition 

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.

Source: https://www.ema.europa.eu/en/news/global-regulators-call-international-collaboration-integrate-real-world-evidence-regulatory-decision

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.

Source: https://www.ema.europa.eu/en/documents/other/information-about-raw-data-proof-concept-pilot-industry_en.pdf 

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. 

Source:  https://health.ec.europa.eu/latest-updates/mdcg-2022-12-harmonised-administrative-practices-and-alternative-technical-solutions-until-eudamed-2022-07-13_en 

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.

Source: https://www.edqm.eu/documents/52006/348324/Press+release+-+Council+of+Europe_EDQM+supports+draft+legislative+proposal+for+a+new+EU++Regulation+on+the+safety+and+quality+of+Blood%2C+Tissue+and+Cells+-+July+2022.pdf/9cdd9b7d-c088-9c71-a08a-25c2599a8c8a?t=1657874072597 

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.

Source: https://www.edqm.eu/documents/52006/66555/02-technical-guide-elaboration-monographs-8th-edition-2022.pdf/46b07f46-779d-687d-1455-74d8a9a515ee?t=1656321894803 

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

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODYyMA== 

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’

Source: https://www.gov.uk/guidance/guidance-on-handling-of-decentralised-and-mutual-recognition-procedures-which-are-approved-or-pending#full-publication-update-history

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.

Source: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices 

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices#MasterFile

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.

Source: https://link.springer.com/epdf/10.1208/s12248-022-00702-4?sharing_token=R7GjnmHA3NNw-prAoc0lHpil69fZbNCDjUAQWCaB_Pu2RctIEDu0hg1U75p_i2a0fUm4Z961N1hBvaQDfx_wOr5V3clHUeiq4bw0WyE3-dp1TEIyZIUPG8459F2PAIYoipFVdG_xYdl91bOynYtq1Py4RmuZCW9aaXkKVVieOYA%3D 

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.

Source: https://admin.ich.org/sites/default/files/inline-files/ICH44_HybridMeeting_PressRelease_2022_0601_FINAL.pdf 

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.

Source: https://www.edqm.eu/documents/52006/602451/EDQM+Annual+report+2021.pdf/c12469ef-0b98-afab-eaa9-5170b7274f0b?t=1653313176032

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.

Source: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-3_en.pdf

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.

Source: https://www.fda.gov/media/158659/download

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:

  1. Provide further context to results from the survey
  2. Add value on informing training associates
  3. Inform future surveys.

Source: https://ich.org/news/2021-free-text-comments-report-and-consistent-cohort-2019-vs-2021-ich-implementation-study-now 

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

Source:https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/public-consultation-concerning-physical-attendance-location-personal-residency-qualified-person_en.pdf

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

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-contract-research-organisations_en.pdf 

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”.

Source: https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland#full-publication-update-history  

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.

Source: https://www.edqm.eu/en/-/new-policy-for-the-development-of-monographs-on-medicinal-products-containing-chemically-defined-active-substance-hydrates-or-solvates 

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. 

Source: https://www.fda.gov/media/158180/download 

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.

Source: https://www.fda.gov/media/157812/download

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.

Source: https://www.gov.uk/government/news/the-mhra-are-seeking-views-to-strengthen-conflicts-of-interest-policy-for-independent-advisors

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.

Source: https://www.gov.uk/government/consultations/consultation-on-a-new-code-of-practice-for-the-expert-advisory-committees

EMA and the EUnetHTA 21 joint work plan publishedThe 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

Source: https://www.gov.uk/government/publications/sunset-clause-request-for-public-health-exemption#full-publication-update-history

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.

Source: https://www.fda.gov/media/121311/download

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.

Source: https://www.edqm.eu/en/news/metals-and-alloys-used-food-contact-materials-and-articles-updated-technical-guide-released

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

Source: https://www.gov.uk/government/publications/herbal-medicines-granted-a-traditional-herbal-registration-thr

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

Source: https://www.edqm.eu/en/news/ph-eur-launch-survey-use-total-organic-carbon-toc-test-replacement-oxidisable-substances-test

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

Source:  https://www.edqm.eu/sites/default/files/medias/fichiers/COVID-19/guideline_for_pandemic_covid-19_vaccine_recombinant_spike_protein080322.doc

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

Source: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/qas21_905_chromatography.pdf?sfvrsn=ca50e451_3

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