HRA guidance on changes to the clinical trials regulations

2nd March 2026

Summary: With less than 60 days to go, the guidance sets out how the updated regulations will change the UK clinical trials framework and what sponsors and researchers need to prepare for ahead of implementation. It explains revisions to definitions and terminology, updates to the approvals process with the MHRA and Research Ethics Committees, new transparency requirements including trial registration and publication of results, changes to pharmacovigilance obligations, and simplified consent arrangements.

The page also highlights an upcoming webinar co-hosted with the MHRA on 12 March to explain the regulatory changes. The webinar is currently full and operating a waiting list. Those who add their name to the waiting list will receive an email if a place becomes available. If a place is not secured, a recording of the webinar will be sent to the email address provided.

Link:
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/clinical-trial-regulations-reform/guidance-on-changes-to-the-clinical-trials-regulations/

Back to Recent News