Lifecycle Governance and Living Safety Documentation

A robust drug safety lifecycle demands continuous governance — not episodic compliance exercises. The concept of "living safety documentation" represents the shift from static regulatory submissions to continuously updated systems that reflect the current state of a product’s safety knowledge in real time.

The Pharmacovigilance Quality System (PVQS), under GVP Module I, is the overarching framework governing how PV is conducted within an organisation — every MAH must ensure qualified, trained staff; current, approved SOPs; accurate, complete, traceable data; documented CAPA for deviations; and regular audits with continuous improvement. Under EU Regulation 2025/1466, the PVQS now explicitly covers third-party service providers — a generic vendor management policy is not sufficient; it requires PV-specific governance of each contracted activity.

PBRERs, prepared with genuine analytical rigour, are the most complete integrated safety assessments produced for a marketed product — revealing emerging patterns before they become signals and providing a documented rationale for continued marketing. AI now assists PBRER preparation — summarising cumulative ICSR data, drafting narrative sections, flagging table-narrative discrepancies — but clinical interpretation, benefit-risk evaluation, and final medical sign-off remain human responsibilities, and inspectors will ask to see exactly who reviewed and signed each section.

The adaptive RMP concept, advancing under EMA consultation in 2025–2026, links the RMP update process directly to the signal management system — when a signal is validated, the RMP is automatically flagged for review and the relevant section updated, reducing the historical lag between signal detection and RMP update that has been a recurring source of inspection findings.