MHRA Updates Guidance on Clinical Trials: Collection, Verification, and Reporting of Safety Events

10th October 2025

MHRA Updates Guidance on Clinical Trials: Collection, Verification, and Reporting of Safety Events

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a revised guidance document detailing the collection, verification, and reporting of safety events in clinical trials of investigational medicinal products. This updated guidance, effective from 1st October 2025, aligns with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28th April 2026. It provides comprehensive instructions on reporting adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), as well as guidelines for annual safety reporting, urgent safety measures, and handling serious breaches. The document also includes new attachments and templates to assist sponsors and investigators in maintaining compliance with the upcoming regulatory changes.

Link: Clinical Trials for Medicines: Collection, Verification, & Reporting of Safety Events

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