The European Medicines Agency (EMA) has published the outcomes of its 21st Industry Stakeholder Platform on the Operation of EU Pharmacovigilance Legislation, held on 20 October 2026. The discussions covered artificial intelligence (AI) in safety monitoring, the expansion of the DARWIN EU real-world evidence network, EudraVigilance reporting performance and upcoming revisions to Good Pharmacovigilance Practices (GVP). Several developments have direct implications for marketing authorisation holders, particularly regarding signal monitoring, periodic safety reporting and risk management plans. AI applications move into pharmacovigilance pilot deployment EMA presented two AI-enabled initiatives currently in pilot...