During the week of October 14th, the Global Index powered by Hoodin recognised 91 regulatory news and updates related to medical devices, IVD, SaMD, pharmaceuticals and biotech (and combination products). Check out what the system recognised as the top pics below, where they are presented as summarised versions together with an analysis of the potential implications. From last week there are important updates and news by FDA (US), MHRA (UK) and TFDA (Taiwan) in this issue of Global Reg Top Picks by Hoodin.
Cut through the noise of regulatory updates and stay ahead with the some of the most impactful news from around the globe—handpicked and analysed just for you.
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Top Picks for October 14 - October 20
Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability. FDA (US) | Published Oct 15
NORTH AMERICA | PHARMACEUTICALS
SUMMARY The FDA has released final guidance regarding the early assessment of certain Type II Drug Master Files (DMFs) under the Generic Drug User Fee Amendments (GDUFA) III.
This guidance aims to enhance the efficiency of generic drug application reviews by allowing DMFs to be reviewed six months prior to the submission of Abbreviated New Drug Applications (ANDAs) or Prior Approval Supplements (PASs). The initiative is part of broader program enhancements under GDUFA III for fiscal years 2023-2027, aimed at accelerating the availability of generic drugs.
IMPLICATIONS Generic Drug Manufacturers: This guidance directly impacts companies involved in the production of generic drugs, as it improves the process for DMF assessments, reducing delays in ANDA approvals. API Suppliers: Active pharmaceutical ingredient (API) suppliers who hold Type II DMFs will benefit from the clarity and efficiency in the review process, enabling them to provide timely responses to FDA queries. Contract Manufacturers: Contract manufacturers handling drug production for ANDA holders may also benefit from the streamlined process as it potentially reduces approval delays. Accelerated ANDA Approvals: The early assessment of DMFs can help companies speed up the approval of ANDAs, reducing time-to-market for generic drugs.
Proactive Engagement Required: DMF holders must ensure timely and accurate submission of required data, as delays in responding to FDA queries can hinder the approval process.
Guidance: Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice. MHRA (UK) | Published Oct 18 EUROPE | PHARMACEUTICALS | BIOTECH
SUMMARY From 1 January 2025, the MHRA will be responsible for granting Conditional Marketing Authorisations (CMAs) for the entire UK, including Northern Ireland, aligning with the Windsor Framework. Until then, CMAs for Northern Ireland remain under the EMA’s jurisdiction.
CMAs will be granted for medicinal products that address an unmet medical need, particularly for life-threatening or serious conditions. These products can be authorised with incomplete clinical data, provided that the data will soon be available and the benefits outweigh the risks.
The definition of "unmet medical need" highlights products that either offer a major therapeutic advantage over existing treatments or provide new solutions where no current satisfactory options exist.
Companies can apply for a CMA, which will be valid for one year and renewable. The authorisation can be converted into a full marketing authorisation once comprehensive data confirms that the medicine’s benefits continue to outweigh its risks.
The MHRA continues to offer Marketing Authorisations under exceptional circumstances for rare conditions or where full data collection is impractical or unethical. After 2025, these will also apply UK-wide.
IMPLICATIONS
Pharmaceutical and Biopharmaceutical Companies: This guidance is particularly relevant to developers and manufacturers of new medicinal products. Companies with innovative treatments, especially those addressing serious and life-threatening conditions, will be impacted.
SMEs in the Pharmaceutical Sector: Smaller pharmaceutical companies in the UK developing medicines for unmet needs or rare diseases may benefit from the national scientific advice service and CMA schemes, with opportunities to seek conditional authorisations and exemptions from fees for advice.
Biotechnology Firms: Companies involved in the development of advanced therapies (e.g., gene therapies or biologics) that target unmet medical needs will find this guidance highly relevant for gaining earlier market access.
Multinational Companies: Firms that currently seek CMA approvals from the EMA for the UK market (particularly Northern Ireland) will need to adjust strategies by shifting CMA applications to the MHRA starting in 2025.
TFDA hosts "2024 APEC International Workshop on Innovative Nucleic acid Medicines Analytical Technology" to Promote Nucleic acid Medicine Testing Techniques Development and International Cooperation. TFDA (Taiwan) | Published Oct 15
ASIA | PHARMACEUTICALS | BIOTECH | IVD
SUMMARY
The Taiwan Food and Drug Administration (TFDA) is hosting an international workshop to promote the development and international cooperation of nucleic acid medicines testing techniques.
The workshop focuses on mRNA vaccines, quality control management, and new technologies related to nucleic acid-based medicines.
The event aims to enhance Taiwan's capabilities in nucleic acid medicine testing and align Taiwan’s regulatory standards with international benchmarks.
The workshop supports the harmonisation of technical standards across APEC economies, which may contribute to reduced trade barriers and accelerated development of nucleic acid medicines. While the workshop fosters important dialogue and networking, the implications are largely potential rather than immediate. The extent of their impact will depend on follow-up actions, collaborations, and the eventual integration of shared insights into regulatory practices. Therefore, it is important for companies to monitor these developments and actively engage in future initiatives stemming from such workshops.
IMPLICATIONS Potential Implications for Pharmaceutical and Biotechnology Companies: The workshop addresses critical advancements in nucleic acid-based therapies, particularly mRNA vaccines and gene therapies. Companies in these sectors should be prepared for future regulatory shifts that may arise from harmonised standards and enhanced quality control practices.
Impact on Nucleic Acid Medicine Developers: Companies focused on the development of nucleic acid medicines are directly affected, as the event centred on their technologies. The sharing of insights on quality control and new applications is essential for maintaining regulatory compliance and product safety.
Relevance for IVD Companies: Companies using nucleic acid-based diagnostic technologies, such as PCR and NGS, should note that improvements in testing techniques and quality control systems discussed at the workshop could influence regulatory requirements for their products. The harmonisation of testing standards across APEC could simplify market entry for new diagnostics.
Call for Monitoring and Engagement: While the workshop fosters dialogue and potential collaborations, companies should remain vigilant about follow-up actions and initiatives that emerge from such discussions. Actively engaging in future developments stemming from these workshops will be crucial for leveraging potential benefits.
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