Regulatory intelligence & pharmacovigilance updates, mapped to your role.

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.

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Sponsors must implement early communication strategies with the CDE regarding RWE study plans as a prerequisite for pediatric indication extension submissions.

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.

Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.

Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.