Latest Regulatory Updates

April 2025

Hello and welcome to the Boyds Regulatory Intelligence Digest. In this edition, we are sharing the latest guidance, insights and key developments from the regulatory agencies - FDA, EMA, and MHRA.

Food and Drug Administration (FDA)

Animal test requirement to be phased out for monoclonal antibodies and other drugs (10 Apr 2025) 

The FDA announced plans to phase out animal testing requirements for development of monoclonal antibodies and other drugs, and instead rely on human-relevant methods, such as in silico and in vitro human-based systems, for safety testing. A detailed roadmap for implementing these plans is provided here.  

Workshop/Webinar: Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration (29 – 30 April 2025)

This FDA-hosted public workshop provides step-by-step demonstrations of the In Vitro Permeation Test (IVPT), described in FDA’s Guidance: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs. While intended for generic drug products, Sponsors of new topical treatments may benefit from discussions regarding IVPT method development, validation, and study conduct, as well as best practices for overcoming challenges. Registration is open for both in-person and virtual attendance. 

Blog: Exploring the FDA’s draft guidance on AI in regulatory decision-making

In January 2025, the FDA issued long-awaited draft guidance on the use of artificial intelligence (AI) in regulatory decision-making for drugs and biological products. In this blog, the Boyds Regulatory Affairs team outlines the new guidance and its aims.

European Medicines Agency (EMA) and the European Union (EU)

Revised Guideline: ICH E6(R3) 

The third revision to ICH E6 represents a major overhaul to the Good Clinical Practice guideline. The new structure in ICH E6(R3) provides clarity and builds on the concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. Quality by Design (QbD) and proportionate risk-based approaches are encouraged throughout the planning and conduct of clinical trials. A presentation outlining key updates in ICH E6(R3) can be found here.

Reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes (17 Mar 2025) 

This reflection paper issued by the EMA focuses on the conduct and analysis of non-interventional studies (NIS) using real-world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes in the EU. Specific considerations for NIS study designs, bias, governance, data quality, and statistical analyses are discussed, including the limitations and how some limitations may be mitigated to support reliability of the evidence generated. 

Updated User Guides for HMA-EMA Catalogues for Real-world Data Sources and studies 

EMA has released an updated guide to the use of the HMA-EMA Catalogues of RWD sources and studies. This “Good Practice Guide” provides recommendations, considerations, and best practices to identify a suitable data source when planning a study. 

Catalogues home page  

User guide for submitting data to the Catalogues (new) (08 Apr 2025) 

Updated list of metadata (08 Apr 2025) 

Updated good practice guide for use of the HMA-EMA Catalogues of RWD sources and studies (08 Apr 2025) 

Draft Guideline on quality of mRNA vaccines (EMA) (27 Mar 2025) 

This new draft guideline for mRNA vaccines provides recommendations on the quality (i.e. manufacturing process, characterisation, specifications, and analytical control) of mRNA vaccines. The draft guideline is open for public comments through 30 Sep 2025. 

Q&A: How third-party audit(s) should be reflected on Part C for QP Declarations (EMA) (11 Apr 2025) 

In this new Questions and Answers document, EMA provides clarification on how third-party audit(s) should be reflected in part C of the QP declaration. Also related is a new Q&A regarding acceptability of third-party audits under EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances 

Q&A re: EU GMP guide part II  Link (Question 3 on web page location) 

Walk-in Clinic: Clinical Trials Information System (CTIS) 

This walk-in clinic provides Sponsors the opportunity to ask CTIS experts questions in real-time. Online training modules for CTIS, a Sponsor handbook, and other CTIS resources are available here. (May 14, 2025)

Blog: Understanding the aims of the EU COMBINE project
This article written by Eamonn McGorwan, Associate Director at Boyds, explores the goals of the EU COMBINE Project - an important initiative working to harmonize regulatory requirements for combined clinical studies involving medicines, medical devices, and in vitro diagnostics across Europe.

Medicines and Healthcare products Regulatory Agency (MHRA), HRA & GOV.UK

New guidance: National assessment procedure for medicines (MHRA) (03 Apr 2025) 

This published guidance provides recommendations on the National Assessment Procedure for UK-wide marketing authorisation (MA) applications. The change for MHRA to regulate medicines across the UK (i.e., Northern Ireland and Great Britain) aims to simplify the regulatory process for Applicants and support uniformity across the UK. 

MHRA: Revised Clinical Trial Legislation – 12-month roll-out (11 Apr 2025) 

The MHRA has introduced the most significant updates to UK clinical trial regulations in over 20 years, aiming to streamline processes, enhance patient safety, and implement risk-proportionate oversight of clinical trials. Of note is the Combined Review, which enables Sponsors to apply for ethics and regulatory approval simultaneously. These reforms to clinical trial regulations in the UK aim to reduce the time from application to first participant from 250 to 150 days. A 12-month roll-out has begun, with the new regulations taking full effect 10 April 2026. 

MHRA Launches Monthly Safety Bulletin 

To help improve safety communications to healthcare professionals regarding medicines and medical devices, MHRA has begun issuing monthly safety bulletins. The bulletins provide a summary of MHRA safety alerts and medicine recalls, drug safety updates, device safety information, and other key safety information regarding healthcare products. 

March 2025 Bulletin