RegulatorsMhraUnited Kingdom
MHRA confirms UK clinical trial safety reporting guidance is effective
Relevant for
Local Safety OfficerRegulatory Intelligence LeadPV Operations LeadPV Quality Lead+2 more
Action needed
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.
Process impact
Local Affiliate ComplianceICSR SubmissionInspection Readiness
SOP impact
4 SOPs may need review
Urgency: HighConfidence: high
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