Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

Healthcare providers must ensure patient registrations and comply with adverse event reporting as per the renewed compassionate use framework, which includes the collection and analysis of safety data.

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

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.