publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated May 23, 2026
MHRA confirms UK clinical trial safety reporting guidance is effective
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.
ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact4 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guidance
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