EMA updates pharmacovigilance requirements and ends EudraVigilance pilot phase
The European Medicines Agency (EMA) has published guidance following the adoption of Commission Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012. This regulation formally ends the signal detection pilot in EudraVigilance by Marketing Authorisation Holders (MAHs), requiring all MAHs with authorised medicinal products in the European Economic Area (EEA), including Northern Ireland, to monitor EudraVigilance data as an additional source of safety information. The deletion of Article 21(2) removes the obligation to submit validated signals via a standalone form, placing full responsibility for signal management on MAHs in line with Good Pharmacovigilance Practices (GVP) Module IX.B. MAHs must now revise their internal procedures to reflect these changes, ensuring EudraVigilance data is integrated into routine signal monitoring and assessments, with frequency adapted to product-specific risks. These requirements take effect 20 days after the regulation’s publication, with further updates to GVP IX expected in the second quarter of 2026.