Pharma GMP News of the Week: 26-Oct-2023
Period: Aug 1, 2023 to Sep 30, 2023
CDSCO Clarifies QR Code Requirements for Top 300 Medicine Brands in India
Date: July 21, 2023
India’s CDSCO has clarified the new requirement for manufacturers of the top 300 medicine brands to add a barcode or QR code to their product labels by 1 August 2023. The codes, which can be printed on secondary labeling in certain circumstances, will carry information such as the unique product identification code and expiry date. The requirement applies to all indigenous and foreign manufacturers marketing these brands in India. Despite previous delays in regulatory requirements, this requirement is set to be implemented as planned.
EMA Overhauls Q&A Document on Clinical Trial Data Publication
Date: July 26, 2023
The European Medicines Agency (EMA) has updated its Q&A document on the publication of clinical trial data, adding 10 new questions. The update aims to help applicants and marketing authorization holders comply with the clinical data publication policy. Key clarifications include the scope of the policy, the process for additional redactions to protect study unmasking/unblinding, and the potential for joint review/publication with Health Canada. EMA also acknowledges the need for further guidance on managing the publication of clinical study reports under both Policy 0070 and the Clinical Trial Regulation.
Swiss-US Mutual Recognition Agreement on Manufacturing Practices Activated
Date: July 27, 2023
The Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA) between Switzerland and the US is now in effect. The FDA and Swissmedic have found each other’s processes for monitoring medicinal product manufacturers to be comparable. This allows them to accept the results of each other’s GMP inspections. Before conducting an inspection, it will be checked if the production site has already been inspected. If so, GMP documents will be shared for evaluation, potentially avoiding an on-site inspection.
Source: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/inkrafttreten-mra-swissmedic-fda.html
Philippine FDA Proposes Incorporation of WHO Guidelines for Postapproval Changes to Vaccines and Biotherapeutics
Date: July 31, 2023
The Philippine FDA is proposing to incorporate WHO guidelines on postapproval changes to vaccines and biotherapeutics into its own rules. The FDA has released a draft circular outlining the revised requirements and application process for these changes. The circular defines key terms and provides implementing details, including the classifications of variations. The FDA aims for all postapproval changes to be based on the latest WHO guidelines and country-specific regulations. The new guidelines will apply to all future postapproval change submissions.
MHRA Issues New Brexit Guidance on Labeling and Packaging of Medicines
Date: August 2023
The UK’s MHRA has released guidance on labeling and packaging of medicinal products under the Windsor Framework, which revises Brexit terms. From 2025, all UK medicinal products must carry a “UK Only” label. The MHRA will allow medicines in legacy EU packaging until the end of 2024. The “UK Only” statement can be applied using a sticker until mid-2025, after which it must be printed directly onto the packaging. The guidance also discusses the disapplication of the Falsified Medicines Directive from Northern Ireland.
MHRA Clarifies Exclusion of Medical Devices from UK’s CE Mark Recognition
Date: August 01, 2023
The UK’s MHRA has clarified that the government’s decision to indefinitely recognize the CE mark does not apply to medical devices. As part of Brexit, the UK created the UKCA, its equivalent of the CE mark. Despite the recent announcement of indefinite recognition of the CE mark to prevent uncertainty and unnecessary costs, this does not extend to medical devices or IVDs. The transition from the CE mark to UKCA still applies to these devices, with the UK set to stop accepting CE-marked medical devices between 2028 and 2030.
Source:
FDA Finalizes Guidance on DSCSA Waivers, Exceptions, and Exemptions
Date: August 04, 2023
The FDA has finalized its guidance on the process for granting or denying waiver, exception, and exemption (WEE) requests under the Drug Supply Chain Security Act (DSCSA). The guidance, which finalizes a draft issued in 2018, also outlines the biennial review process for previously approved WEEs. Changes include a requirement for electronic submission of requests and new sections on how to request reconsideration of the scope of a granted WEE or a denied request. The guidance specifies that WEEs will be reviewed every two years to assess if material changes in circumstances warrant their continuation.
Source: https://www.fda.gov/media/113342/download
FDA Establishes Acceptable Intake Limits for Nitrosamines in Drugs
Date: August 04, 2023
The FDA has issued a final guidance setting acceptable intake (AI) limits for nitrosamine drug substance-related impurities (NDSRIs) in drug products and active pharmaceutical ingredients (APIs). Manufacturers are called upon to evaluate NDSRI risks within three months and complete assessments by 1 November 2023. By 1 August 2025, any NDSRIs in drug products should meet the FDA-recommended AI limit. The guidance outlines a three-step mitigation strategy for assessing the presence of NDSRIs and introduces a methodology for assigning a recommended AI limit to an NDSRI. The AI limit approximates an increased cancer risk of one additional case in 100,000 people based on daily exposure to the impurity over a lifetime.
Source: https://www.fda.gov/media/170794/download
Online Retail Platforms in India Deny Responsibility for Non-Compliant Medicine Trade
Date: August 08, 2023
Online retailers in India have denied responsibility for the sale of non-compliant medicines, stating they are merely intermediaries connecting customers and licensed pharmacies. This comes after the Central Drugs Standard Control Organization (CDSCO) sent show-cause notices to various firms involved in online drug sales. The Indian government has drafted rules for the sale and distribution of medicines online, which include provisions for registering and inspecting e-pharmacies, a procedure for online drug distribution or sale, and a ban on advertising drugs through e-pharmacies.
Source: https://pib.gov.in/PressReleasePage.aspx?PRID=1946709
FDA Drafts Guidance on Classification Categories for Biosimilar Supplements
Date: August 11, 2023
The FDA has published draft guidance to assist sponsors in determining the appropriate supplement category for biosimilar applications and outlines the review process. The guidance covers six classification categories for supplements, established under the Biosimilar User Fee Amendments of 2022 (BsUFA III). These categories range from Category A, for straightforward changes incorporating safety labeling updates, to Category F, reserved for supplements seeking an initial determination of interchangeability. The review goals will vary depending on the type of supplement, with safety updates reviewed faster than those adding new efficacy data. The guidance aims to ensure consistent review processes across divisions.
Source: https://www.fda.gov/media/170906/download
FDA Updates Draft Guidance for Biosimilar Meetings Under BsUFA III
Date: August 11, 2023
The FDA has published a revised draft guidance to assist biosimilar developers in convening meetings with the agency. The guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products”, replaces a previous draft from June 2018. Changes include modifications to data expectations in Biosimilar Initial Advisory meeting requests, the addition of Biological Product Development Type 2a meetings, and updates to available meeting formats. The guidance outlines five types of formal meetings for discussing the development and review of a biosimilar or interchangeable product. The FDA emphasizes the importance of efficient, consistent procedures for conducting these meetings.
Source: https://www.fda.gov/media/113913/download
FDA updates Guidance on OTS Software for Medical Devices
Date: August 11, 2023
The FDA has updated a final guidance on off-the-shelf (OTS) software used in medical devices, aiming to reduce administrative burdens for sponsors. The updated guidance moves away from the hazard analysis approach of the 2019 version, instead asking sponsors to conduct an OTS software risk assessment and provide varying levels of documentation based on potential risk. The guidance relies on a previous premarket submission guidance on medical device software and asks sponsors to submit a risk management file and plan. The updated guidance aligns more closely with the FDA’s broader approach to medical device software and international consensus standards.
Source: https://www.fda.gov/media/71794/download
Indian Medtech Industry Challenges Proposed Reform Bill
Date: August 2023
The Association of Indian Medical Devices Industry (AiMeD) has expressed concerns about a bill set to repeal the Drugs and Cosmetics Act, 1940. AiMeD has criticized the bill for being unreasonable and unimplementable, arguing that it was created without involving medical device regulatory specialists. The group has raised issues such as the excessive threat of imprisonment for noncompliance, lack of patient safety considerations, and the legalization of “pseudo manufacturing”. AiMeD also criticized the application of pharma-centric rules to the medtech sector and compared the Indian proposal unfavorably to international regulatory frameworks. The group is pushing for major changes to the proposals.
Source: https://twitter.com/MiIAiMeD/status/1690189972131696641
PMDA Updates Consultation Process for Industry Guidance
Date: August 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has revised its consultation process to provide more comprehensive guidance to industry stakeholders. The new process includes three types of consultations for early-stage projects: general consultation, pre-consultation meetings, and full scientific discussions. While the first two types are free, a fee applies to full consultations. However, PMDA offers a 90% fee reduction for certain qualifying applicants. This update aims to provide clearer and more supportive guidance to companies in the early stages of product development.
Source: http://pmda.go.jp/english/review-services/consultations/0002.html
New Zealand Updates Guidelines on Acceptable Overseas Evidence of GMP
Date: August 2023
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published an updated version of its guidelines on the manufacture of medicines. The update clarifies examples of acceptable evidence from audits by authorities in the United States and European Union. The guidelines now include a broader list of recognized authorities and provide more information about using evidence from FDA audits. Medsafe also clarified the requirements for certificates published in EudraGMP, the EU’s database of manufacturing authorizations and certificates of GMP compliance.
Source: https://medsafe.govt.nz/regulatory/Guideline/GRTPNZ/manufacture-of-medicines.pdf
India Releases New Policy to Boost R&D and Innovation in Pharma-Med Tech Sector
Date: August 18, 2023
India’s Department of Pharmaceuticals (DoP) has unveiled the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector. The policy aims to create a regulatory environment that encourages innovation and research in product development. It proposes four measures: process optimization, technology-based platform, regulatory capacity enhancement, and legislation review. The goal is to reduce approval times for innovative products by at least 50% within two years, enhance transparency and predictability, build in-house expertise in emerging areas, and identify legislative friction points. The policy is published alongside the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), which aims to strengthen the country’s research infrastructure.
Boosting EU-UK Medicine Trade through Greater Mutual Recognition
Date: August 2023
The European Parliamentary Research Service (EPRS) suggests that greater mutual recognition of product rules and conformity assessments between the EU and UK could enhance trade, including medical products. Post-Brexit, the UK sought to establish its own rules, leading to trade barriers. EPRS’s report assesses the EU-UK Trade and Cooperation Agreement’s effects, noting that while it has facilitated trade, new barriers have emerged due to lack of mutual recognition of regulations. The UK has paused plans to implement its own standards in some areas but is proceeding with an alternative to the EU’s CE mark for medical devices. EPRS recommends further steps to lower trade barriers, especially in sectors like automation, finance, agriculture, and medicine. The feasibility of mutual recognition will depend on how the UK uses its freedom to set its own rules.
Source: https://www.europarl.europa.eu/RegData/etudes/STUD/2023/747433/EPRS_STU(2023)747433_EN.pdf
FDA Delays DSCSA Track and Trace Requirements by One Year
Date: August 28, 2023
The US FDA has granted a one-year reprieve from DSCSA requirements for system-wide electronic interoperable systems for tracking products through the supply chain. Originally due by 27 November 2023, enforcement will now begin on 27 November 2024. The FDA emphasizes that this should not delay efforts to implement enhanced drug distribution security requirements. The decision responds to stakeholders’ concerns about readiness and the complexities of implementing DSCSA. The FDA also will not enforce the requirement for systems and processes to accept saleable returns.
Source:
https://www.fda.gov/media/171592/download
https://public-inspection.federalregister.gov/2023-18359.pdf
WHO Urges Pharmaceutical Labs to Prepare for Operational Disruptions
Date: August 2023
The World Health Organization (WHO) has updated its guidelines for pharmaceutical control labs, first issued in 1999, urging them to maintain crisis management plans. The update includes a new section on strategic planning and revisions to sections on performance evaluation, risk management, crisis management, communication management, and measurement uncertainty. The guidelines now apply to all pharmaceutical quality control labs, not just national ones. Labs are advised to create a business continuity plan, analyze potential risks, and establish recovery strategies. These plans should be tested regularly and disseminated among all involved parties.
Source: https://www.who.int/
FDA Issues Additional Guidance on DSCSA Electronic Tracking Requirements Delay
Date: August 30, 2023
The US FDA has published two additional guidances detailing the one-year extension from enforcement of requirements for electronic product tracking under the Drug Supply Chain Security Act (DSCSA). The guidances are part of the FDA’s plan to extend the DSCSA deadline, allowing trading partners to develop and refine their electronic systems. One guidance describes enhanced drug distribution security requirements for DSCSA at the package level, while the other outlines compliance policies for wholesale distributors and dispensers on product identifier verification. The FDA does not intend to take action against wholesale distributors who do not comply with certain DSCSA requirements if they do not have compliance systems in place.
Source:
Australia’s New Policy on Injectable Product Information
Date: August 30, 2023
Starting from 1st September, Australia’s Therapeutic Goods Administration (TGA) has ceased the requirement for manufacturers to include printed product information in the packaging of injectable products administered by healthcare professionals. This decision was based on feedback received by TGA, weighing the environmental impact and the risk of outdated information against the benefits of hard copies. However, injectables administered by patients or carers will still include printed information. The policy aims to ensure safety and minimize waste, while also considering the potential increase in package size due to hard copies. Some products already in the market will continue to have printed package inserts.
MHRA’s Revised Pharmacovigilance Compliance Model and Its Impact on Inspection Findings
Date: September 04, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a revised good pharmacovigilance practice (GPvP) inspection model in the 2020 to 2021 financial year. The model aims to facilitate the selection of appropriate pharmacovigilance systems, products, and non-interventional studies for inspection. A significant area of focus in the inspection findings was risk management, with findings spread across all subtopics, emphasizing the importance of managing risk throughout the product lifecycle and across critical pharmacovigilance processes. MHRA plans to continue applying a risk-based approach to inspection scheduling, prioritizing visits based on product risk profile, complexity of pharmacovigilance systems, and intelligence from various sources. Inspections will be conducted either on-site or remotely based on several factors.
FDA’s Draft Guidance on Post-Warning Letter Meetings under GDUFA III
Date: September 05, 2023
The US Food and Drug Administration (FDA) has issued a draft guidance outlining the process for post-warning letter meetings under the Generic Drug User Fee Amendments (GDUFA III). The guidance details how facilities can request a meeting with the FDA to discuss corrective actions for good manufacturing practice deficiencies. These meetings, which may be conducted via video conference, teleconference, or face-to-face, are generally scheduled six months after the facility’s initial response to the FDA warning letter. However, earlier meetings may be granted if beneficial. The guidance emphasizes that these meetings do not halt FDA regulatory actions and that the advice provided is not binding on the agency. Facilities are required to submit electronically a complete meeting package, including a corrective and preventive action plan and supplementary information demonstrating systemic remediation of deficient practices. The FDA maintains the right to deny meeting requests for various reasons, including inadequate remediation progress or incomplete meeting packages.
Source: https://www.fda.gov/media/171785/download
FDA Finalizes Guidance on Tracing Products Through Supply Chain”
Date: September 06, 2023
The US Food and Drug Administration (FDA) has finalized its guidance on the use of electronic standards for tracing products through the pharmaceutical supply chain. The guidance allows trading partners to use portals and email exchanges for tracking drug products, particularly benefiting smaller pharmacies that may lack encrypted internet connections for exchanging Electronic Product Code Information Services (EPCIS) information. This decision comes in response to requests from industry groups, including the Association for Accessible Medicines (AAM), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Healthcare Distribution Alliance (HDA). The guidance is largely in line with the Drug Supply Chain Security Act (DSCSA) requirements, which mandate enhanced drug tracking from 27 November 2023. However, the FDA recently announced a one-year delay in implementing these requirements.
Source: https://www.fda.gov/media/171796/download
MHRA’s Business Plan to Eliminate Backlogs and EMA’s Proposed Changes for Depression Treatments
Date: September 07, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has committed to clearing its current service backlogs by the end of the fourth quarter of the 2023-2024 financial year. This is part of MHRA’s business plan, which includes identifying service improvements, eliminating backlogs, delivering phase one of an innovation-enabling and risk-proportionate medicines compliance strategy, and fully embedding the new SafetyConnect vigilance system.
In other news, the European Medicines Agency (EMA) has published draft guidelines on the clinical investigation of medicinal treatments for depression. The document has been rewritten and restructured to reflect changes in the treatment and drug development landscape since its finalization in 2013.
FDA Proposes 510(k) Program Modernization with New Draft Guidances”
Date: September 07, 2023
The US Food and Drug Administration (FDA) is taking steps to modernize the 510(k) program, which includes updates to its Safety and Performance Based Pathway and electronic Submission Template And Resource (eSTAR) program. From October 2023, non-exempt 510(k) submissions must be submitted through eSTAR. The FDA has also released three new draft guidance documents concerning different aspects of the 510(k) program. The first addresses best practices for selecting a predicate device, the second expands FDA’s policies on when clinical data on substantial equivalence is necessary in a 510(k) submission, and the third provides evidentiary expectations for 510(k) devices. These steps aim to enhance predictability, consistency, and transparency in the use of clinical data in 510(k) submissions.
European Commission Seeks Feedback on Postmarket Variation Framework Improvement
Date: September 2023
The European Commission is soliciting feedback on how to enhance the postmarket variation framework for medicines. This initiative aims to bridge the gap until the implementation of changes through the revision of general pharmaceutical legislation. The Commission seeks to reduce the administrative burden for marketing authorization holders and authorities, thereby freeing up resources currently consumed by the large number of variations. The initiative may include re-classifying some variations into lower categories and/or introducing additional flexibility, particularly regarding the level of technical information required. The Commission aims to enable marketing authorization holders to introduce timely manufacturing or quality improvements, embracing new technologies and digitalization approaches. Submissions are open until 26 September.
Source: https://eur-lex.europa.eu/
FDA issued guideline on “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
Date: September 08, 2023
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility considerations for medical device sponsors in their premarket submissions. The updated guidance now includes a list of certain synthetic polymers and natural fabrics that are exempt from biocompatibility requirements. These materials, which FDA believes pose a very low biocompatibility risk due to their long history of safe use, include 24 polymers and three fabrics. Sponsors are encouraged to suggest other materials for inclusion in the list. The FDA plans to periodically reassess the list and has recommended the use of its Q-Submission process for early discussions about the use of listed materials in specific products.
Source: https://www.fda.gov/media/142959/download
FDA Launches CMC Development and Readiness Pilot for Expedited Drugs”
Date: September 11, 2023
The US Food and Drug Administration (FDA) has announced a limited chemistry, manufacturing, and controls (CMC) development and readiness pilot (CDRP) program to facilitate the development of breakthrough or accelerated review products. The pilot aims to enhance CMC readiness for selected products with accelerated clinical development timelines, increase communication between FDA and sponsors, and provide patients with earlier access to these products. Under the pilot, FDA will offer product-specific CMC advice during product development, additional CMC-focused Type B meetings, and a limited number of extra CMC-focused discussions. Sponsors interested in participating should submit a request as an amendment to their Investigational New Drug (IND) application. The FDA will select nine applications for the pilot, with two-thirds of these products from the Center for Biologics Evaluation and Research (CBER) and one-third from the Center for Drug Evaluation and Research (CDER).
Source: https://www.regulations.gov/document/FDA-2022-N-2396-0004
TGA Initiates Medical Devices Vigilance Pilot Program”
Date: September 11, 2023
Australia’s Therapeutic Goods Administration (TGA) is launching a pilot program aimed at improving the monitoring of medical device performance and enhancing product safety oversight. The voluntary program, which will run for 12 months, offers sponsors the opportunity to work with TGA and gain a better understanding of their post-market regulatory requirements. Participants are expected to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT), which will be used by TGA to select sponsors for desktop audits, onsite inspections, or both. The initiative is designed to support regulatory education and compliance, and the insights gathered will contribute to the ongoing development of the program and enhance the safety of Australian patients using medical devices.
Source: https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot
Medsafe’s Overview on Supply Restrictions of Controlled Drugs”
Date: September 2023
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released an overview of the restrictions on the supply of controlled drugs. The report explains that due to their potential for harm, some products are subject to additional supply restrictions. Supply of controlled drugs requires individual approval from the New Zealand Minister of Health, unless an exemption or blanket approval is in place, and each consignment needs a Licence to Import Controlled Drugs. The requirements vary between different products. For instance, supply of lysergic acid requires ministerial approval, while medicinal cannabis is exempt from this requirement but is still classified as a controlled drug. Some other molecules, including ephedrine, are covered by blanket approvals.
Source: https://medsafe.govt.nz/profs/PUArticles/PDF/Prescriber-Update-44-No.3-September-2023.pdf
Japanese Pharmacopoeia Drafts Monograph on Diagnostic Dye for Public Consultation”
Date: September 2023
The Japanese Pharmacopoeia (JP) has released a draft monograph for public consultation on indocyanine green, a dye used in various medical applications such as cardiac output tests, liver function tests, and eye procedures. The draft monograph provides details on how to identify the molecule, along with information on appropriate containers and storage conditions. Feedback on the draft is being accepted until November 30. This move by JP is aimed at updating its position on the dye, complementing the existing reference standard provided by the US Pharmacopeia.
Source: https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/pub-comments/jp/0036.html
EMA’s Revised Guidelines for Depression Treatments and Pharma’s Meeting with Ukrainian Government”
Date: September 11, 2023
The European Medicines Agency (EMA) has published draft guidelines on the clinical investigation of medicinal treatments for depression. The guidelines have been rewritten and restructured to reflect changes in the treatment and drug development landscape. The draft covers the definition and identification of partial and non-responders, the design of trials for patients with treatment-resistant depression, and the clinical development requirements for targeting sub-domains of depression. Additionally, EMA has added sections on rapid-acting antidepressants and psychedelics.
In other news, pharmaceutical trade groups have met with the Ukrainian government to discuss the creation of an independent regulatory agency. The meeting covered the need for transparent and efficient regulatory processes, the creation of independent regulatory and health technology assessment bodies, restarting clinical trials in Ukraine, and an agreement on manufacturing inspections. These actions aim to improve Ukraine’s regulatory environment and prepare the country for potential accession to the EU.
FDA’s Draft Guidance on Clinical Pharmacology and Labeling for Peptide Drug Products
Date: September 11, 2023
The US Food and Drug Administration (FDA) has released a draft guidance outlining clinical pharmacology and labeling considerations for peptide drug products. The guidance, intended to assist industry in the conduct of development programs, covers the definition and identification of partial and non-responders, the design of trials for patients with treatment-resistant depression, and the clinical development requirements for targeting sub-domains of depression. Additionally, it includes sections on rapid-acting antidepressants and psychedelics. The FDA has yet to set dates for the start and end of the consultation.
MedTech Europe Advocates for Structural Reform of MDR and IVDR
Date: Sep 14, 2023
MedTech Europe and 34 national associations have called on the European Union (EU) Commissioner for Health to implement comprehensive structural reforms to address challenges created by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The trade groups argue that the regulations have failed to provide a robust, transparent, predictable, and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation. They propose three main reforms: a more efficient and fit-for-purpose CE marking system; a system that supports medtech innovation; and a single structure that oversees and manages the regulatory system. The groups are urging the EU to formally elevate the need for comprehensive structural reform within Europe’s health policy debates.
FDA’s Breakthrough Devices Guidance Now Includes Technologies Addressing Health Disparities
Date: September 15, 2023
The US Food and Drug Administration (FDA) has updated its guidance on the breakthrough device program to include technologies that benefit populations impacted by health care disparities. The update also adds criteria for deciding whether a device provides a “more effective” treatment and expands the program’s criteria to include non-addictive products for treating pain or addiction. The FDA has adopted most of the changes proposed in a draft guidance issued last October. Since the launch of the breakthrough program in 2018, the FDA has granted breakthrough status to 839 devices.
Source: https://www.fda.gov/media/162413/download
FDA’s Final Guidance on Medical Device Voluntary Improvement Program
Date: September 15, 2023
The US Food and Drug Administration (FDA) has finalized its guidance for the Voluntary Improvement Program (VIP), a program managed by the Medical Device Innovation Consortium (MDIC) that uses an appraisal similar to the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. The guidance clarifies that the VIP is not a regulatory inspection or audit, and it does not replace FDA inspections. The program can be used to benefit populations impacted by health care disparities. The FDA has also added new criteria for deciding whether a device provides a “more effective” treatment and expanded its criteria to include non-addictive products for treating pain or addiction.
FDA Seeks Stakeholder Input on Quality Management Maturity Program
Date: September 15, 2023
The US Food and Drug Administration (FDA) is seeking stakeholder input as it develops a voluntary Quality Management Maturity (QMM) program. The program aims to create a strong quality culture mindset, recognize firms with advanced QMM practices, target areas for improvement, and minimize risks to product availability. Trained assessors would conduct the QMM assessments, covering five practice areas including management commitment to quality, business continuity, advanced pharmaceutical quality systems, technical excellence, and employee engagement and empowerment. The FDA is seeking input on various aspects of the program, including anticipated advantages, benefits of participation, potential unintended consequences, and the content of QMM reports. The deadline for commenting is December 14.
FDA’s Final Guidance on Acceptable Confirmatory Evidence for Medical Devices
Date: September 19, 2023
The US Food and Drug Administration (FDA) has released a draft guidance outlining the types of confirmatory evidence it will accept from sponsors seeking to demonstrate the effectiveness of their medical devices using one adequate and well-controlled clinical investigation. The guidance, which aims to accommodate more products for serious diseases lacking effective treatments, includes seven types of acceptable confirmatory evidence. These include clinical evidence from a related indication, mechanistic or pharmacodynamics evidence, evidence from a relevant animal model, evidence from other members of the same pharmacologic class, evidence from natural history, real-world data/evidence, and evidence from expanded use of an investigational drug. The FDA emphasizes that this list is not exhaustive and that the quality and quantity of confirmatory evidence are important considerations.
IMDRF’s Updated Guidance on Personalized Medical Devices
Date: September 2023
The International Medical Device Regulators Forum (IMDRF) has published a guidance on Personalized Medical Devices (PMDs), aiming to harmonize how different regulatory bodies oversee such devices. The guidance defines three categories of PMDs: custom-made medical devices, patient-matched medical devices, and adaptable medical devices. It provides general requirements to identify each category, and manufacturing and record-keeping requirements to ensure manufacturing consistency and that the products are trackable. The IMDRF emphasizes that this guidance is intended to accommodate more products for serious diseases that lack effective treatments, and to advance health equity.
MHRA’s Innovative Devices Access Pathway for Accelerated Access to Medical Technologies
Date: September 19, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Innovative Devices Access Pathway (IDAP), a new program designed to expedite access to innovative medical technologies. The IDAP, first announced in May 2023, offers support and benefits such as system navigation advice, priority clinical investigation, assistance with health technology assessment adoption, and exceptional use authorization if safety standards are met. The program is open to medical technologies that address significant unmet needs and are yet to receive regulatory approval or clearance. Applicants must provide proof-of-concept data on a near-final prototype and have already sought clinical input from at least one UK health organization or medical charity. Applications for the IDAP pilot are being accepted until October 29.
Source: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap
EMA’s Clarifications on Biological Medicinal Products
Date: September 2023
The European Medicines Agency (EMA) has published a question-and-answer document addressing various aspects of biological medicinal products. The document, created by EMA’s Biologics Working Party, answers 14 questions on topics such as process validation, biosimilars, and polysorbate testing. Key clarifications include that routine testing for process-related impurities is not necessary if consistent elimination has been demonstrated by validation studies, and characterization results of the reference product may be used for clinical justification of the specification limits of a biosimilar. Additionally, if degradation is a risk, manufacturers should include a test for polysorbate in both the routine release and stability specifications.
FDA’s Guidance on Labeling of Drug Use-Related Software Outputs
Date: September 19, 2023
The US Food and Drug Administration (FDA) has released draft guidance on how to include software outputs of drug use-related software in prescription labeling. The guidance defines prescription drug use-related software and considers end-user output from such software as a type of prescription drug labeling. The FDA has provided specific recommendations on what to include in the prescribing information for drug use-related software. The guidance is intended to align with initiatives across all product centers, including digital health initiatives, and does not alter the current regulatory framework.
Source: https://www.fda.gov/media/172165/download
FDA Guidance on Formal Meetings Adds New Categories, Timelines
Date: September 22, 2023
The US Food and Drug Administration (FDA) has issued revised draft guidance to help sponsors understand the different types of meetings they can request for questions related to their applications and describes the timelines associated with these requests. The guidance, announced on 21 September 2023, adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings. The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This draft guidance replaces an earlier version issued in December 2017. Comments can be submitted until 21 December 2023.
Source: https://www.fda.gov/media/172311/download
FDA to Continue Using Remote Inspection Tools for Pending Applications
Date: September 22, 2023
The US Food and Drug Administration (FDA) has issued a draft guidance formalizing its plans to use alternative tools, including remote regulatory assessments (RRA) and remote interactive evaluations (RIE), to assess drug manufacturing facilities’ compliance with good manufacturing practices (GMPs). This approach, which was successful during the COVID-19 pandemic, will continue to be used when appropriate. The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), but excludes post-approval inspections and other types. FDA will consider various factors in deciding whether to inspect onsite or use alternative methods. While participation in an RRA is mandatory, an RIE is voluntary. Non-compliance may result in delayed action on the application or a complete response letter (CRL) to the manufacturer.
Source: https://www.fda.gov/media/172290/download
FDA’s IT Strategy Focuses on Modernization and AI
Date: September 2023
The US Food and Drug Administration (FDA) has published its Information Technology Strategy for Fiscal Years 2024 to 2027. The strategy emphasizes modernization, integration of ecosystems across the agency, improved data sharing, adoption of new technologies, and investment in talent and leadership. The FDA aims to create a “shared OneFDA ecosystem” for enhanced collaboration and communication, promote transparency, optimize investments, and strengthen governance. The strategy also includes improving the IT infrastructure through modernization efforts, adopting a “Zero Trust” approach for cybersecurity, enabling broad-level data sharing, analyzing the potential and risks of emerging technologies like AI, and building a team of experts to keep the agency at the forefront of IT changes. This strategy represents a shift from an Office of Digital Transformation (ODT)-only IT strategy to an enterprise IT strategy designed in collaboration with FDA’s Center and Office partners.
Source: https://www.fda.gov/media/172067/download?attachment