Navigating the Regulatory Maze: Key Updates from FDA and EMA (July 2024)

Feeling lost in the ever-changing world of medical device and drug regulations? Don't worry, we've got you covered! This month's Boyds Regulatory Intelligence Digest dives into the latest updates from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing you with the need-to-know information to ensure your products stay compliant.

Modernization of the FDA's Drug Approval Process:

The Center for Drug Evaluation and Research (CDER) has released a report outlining progress in its ongoing initiative to modernize the New Drugs Regulatory Program (NDRP). This modernization aims to streamline the review process and ensure the continued effectiveness of new drugs reaching patients.

Key Regulatory Updates from the FDA:

IVD Regulations: The FDA issued a final guidance document clarifying regulations for in vitro diagnostic (IVD) products, including laboratory-developed tests (LDTs). This includes a phase-out plan for the current enforcement discretion approach for LDTs.

Inspection Rights: The FDA released a new guidance document outlining the circumstances that constitute delaying, denying, or limiting an FDA inspection. This clarifies the agency's expectations for smooth and transparent inspections.

Biosimilars Interchangeability: The FDA released a draft guidance document on considerations for demonstrating interchangeability with a reference product for biosimilars. This update reflects the agency's evolving experience with biosimilar products.

Bioresearch Monitoring: The FDA published draft guidance documents on processes and practices for Bioresearch Monitoring (BIMO) inspections. These documents detail the FDA's approach to ensuring the quality and compliance of clinical research.

AI in Medical Devices: The FDA published links to six research areas where its AI program will conduct regulatory science research. This highlights the growing importance of AI in medical devices and the need for clear regulatory frameworks.

What's New at the EMA and the EU?

Boosting Clinical Trials: The EMA initiated two new advice pilots as part of the Accelerating Clinical Trials in the EU (ACT EU) initiative. These pilots aim to improve the quality and efficiency of clinical trial applications.

Scientific Advice and Protocol Assistance: The EMA updated its webpages on Scientific Advice (SA) and Protocol Assistance (PA) to reflect the new advice pilots for clinical trials and offer additional resources for applicants developing new biosimilars.

Simultaneous National Scientific Advice: The EMA updated its guidance on Simultaneous National Scientific Advice (SNSA), a program that allows applicants to seek harmonized advice from multiple national competent authorities concurrently.

CAR-T Cell Therapies and Secondary Malignancies: Following an evaluation of data on secondary malignancies associated with CAR T-cell therapies, the EMA has recommended updates to product information and risk management plans for these products.

ICH M12 Guideline on Drug Interaction Studies: The ICH M12 Guideline on drug interaction studies was adopted by the EMA, superseding the existing EMA guideline on the same topic.

New Guidance on Orphan Medical Devices: The Medical Device Coordination Group (MDCG) published new guidance for determining when a medical device qualifies as an "orphan device" under the Medical Devices Regulation.

Post-Authorization Changes to Marketing Authorizations: The European Commission is seeking stakeholder feedback on proposed changes to the rules governing post-authorization changes to the terms of a Marketing Authorization.

Stay Informed, Stay Compliant

Remember, this digest is just a snapshot of the latest regulatory developments. By staying informed about these changes, you can ensure your medical devices and drugs meet all necessary requirements and reach the market smoothly. For a deeper dive into any of these updates, feel free to contact a member of the Boyds Regulatory team.