Latest Regulatory Updates

July 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)

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T-cell Immunotherapies

The FDA eliminated REMS requirements for all approved autologous chimeric antigen receptor (CAR) T-cell therapies, including those targeting CD19 and BCMA. The Agency determined that risks like cytokine release syndrome and neurotoxicity can now be managed through product labeling alone. This decision removes burdens such as facility certification and extended monitoring, reducing patient restrictions and improving access to these approved therapies while maintaining ongoing safety surveillance.

New: Commissioner's National Priority Voucher Program

The FDA announced a new priority review program called the “Commissioner's National Priority Voucher” (CNPV). The program introduces a team-based review process intended to shorten NDA review timelines from approximately 10-12 months to 1-2 months, aided by early submission of CMC information and draft labelling at least 60 days prior to submission of the final application. The CNPV distinguishes itself from other priority review programs by aiming to support US national priorities such as addressing a US health crisis, delivering more innovative cures to Americans, addressing unmet public health needs, and increasing domestic drug manufacturing.

FDA Roles out Artificial Intelligence (AI) Tool Agency-Wide

FDA introduced a large language model, generative AI tool named Elsa, to assist FDA staff with reading, writing, and summarizing. It's important to distinguish the intent of Elsa is to improve operational efficiency, not support regulatory decision making.

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

Draft Act: New Draft Guideline: ICH E21 – Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials of an expert panel on orphan and pediatric devices

This new draft guideline provides recommendations on how to include and/or retain pregnant and breastfeeding people in pre- and postmarketing clinical trials, ensuring safe and effective treatment options for these populations. The public comment period is open until 15 September 2025.

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

MHRA: New Post-Market Surveillance Regulations for Medical Devices

The MHRA issued new regulations for post-market surveillance for medical devices, which applies to UKCA- and CE-marked devices placed on the Great Britain market after 16 June. Once devices are on the market, “manufacturers are now required to collect and assess real-world safety and performance data; report serious incidents to the MHRA within 15 days (previously 30); submit essential communications on patient safety (Field Safety Notices) to the MHRA for review before sharing with users; and provide PMS Reports or Periodic Safety Update Reports (PSUR) within 3 days of request.”

Note that the PMS regulations do not apply to devices subject to clinical investigation.

A brief video summary of the new PMS legislation is available here, and additional guidance for manufacturers can be found here.


MHRA: New Draft Guidance After Regulations Come into Effect 28 Apr 2026

New regulations for running clinical trials in the UK were signed into law in April of this year, which aim to streamline processes, enhance patient safety, and implement risk-proportionate oversight of clinical trials. The MHRA has issued nine new draft guidance documents to help Sponsors prepare for the implementation of the new regulations, which take full effect 28 April 2026.