Regulatory Updates

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466 | QbD Group

Key updates

 

 

What does this mean to you?

This amendment closes long-standing operational gaps: it codifies what many inspectors already expect on third-party control, tightens signal management timelines, and pushes convergence with IDMP and robust RMM effectiveness reporting. MAHs should update contracts, refresh audit plans, and adapt SOPs for EV monitoring and reporting.

Changes take effect from 12 February 2026, so preparations should begin now.