EMA Safety Updates alt

Signal Management: EudraVigilance Database and Safety Monitoring

EMA describes the EU signal management framework for detecting and investigating safety signals from adverse drug reactions. The Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012, terminates the pilot on signal detection by Marketing Authorisation Holders (MAHs) in EudraVigilance and establishes updated requirements applicable to all MAHs with medicinal products authorised in the EEA. A dedicated Q&A document has been published to support MAHs in adapting to the new obligations, with updates to GVP Module IX to follow.

EU Good Pharmacovigilance Practices Guidelines Cover GVP Modules

EMA publishes comprehensive guidance on Good Pharmacovigilance Practices (GVP), covering 16 modules (I-XVI) plus product-specific chapters for vaccines, biological medicinal products, and paediatric populations. Amendments to Commission Implementing Regulation (EU) 2025/1466 are applicable, and guidance will be updated accordingly. GVP modules impacted by recently adopted ICH-E2D(R1) and ICH-M14 guidelines will also be revised; in the interim, entities should apply those ICH recommendations. The guidance applies to centrally and nationally authorised medicines across the EU.

Direct Healthcare Professional Communications: What They Are and When Used

The European Medicines Agency publishes this explanatory page on Direct Healthcare Professional Communications (DHPCs), describing when marketing authorisation holders may issue safety communications to healthcare professionals. DHPCs cover suspension or withdrawal of marketing authorisations for safety reasons, important changes to indications or contraindications, quality problems, and medicine supply shortages linked to safety or efficacy issues. National competent authorities may adapt agreed EU-level DHPC texts to their local situation.