What changed
MHRA’s GOV.UK guidance “Clinical trials for medicines: collection, verification and reporting of safety events” states that, because the amended Clinical Trials Regulations took full effect on 28 April 2026, the guidance “should now be considered effective.” Supporting MHRA clinical trials hub and related guidance pages also indicate the new regulations came into force on 28 April 2026 and that related guidance is no longer in draft.
Why it matters
This is a compliance-relevant status change for UK clinical-trial safety operations: a document previously treated as draft is explicitly described by MHRA as effective following the regulations taking full effect on 28 April 2026. The guidance scope covers core PV activities in trials—MedDRA coding, AE/SAE reporting, reference safety information (RSI), SUSAR reporting, annual safety reporting, urgent safety measures, serious breaches, and temporary trial suspension—so sponsors and service providers may need to evidence alignment through controlled procedures, training records, and inspection-ready documentation for ongoing and onboarding UK IMP trials.
Practical implication
Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.