What is pharmacovigilance?

Pharmacovigilance is the ongoing monitoring of the safety of medicines after they are authorised, and the set of activities used to detect, assess, understand, and prevent adverse effects. In the European Union it is coordinated by the European Medicines Agency and national competent authorities, supported by the EudraVigilance database of suspected adverse reactions. Marketing authorisation holders must operate a pharmacovigilance system, submit periodic safety update reports, run signal detection, and carry out risk management planning. When a safety signal is confirmed, regulators can update product information, restrict use, or withdraw a product. Pharmacovigilance is a core part of the pharmaceutical regulatory lifecycle because a medicine's full safety profile only emerges once it is used in large and diverse patient populations in real-world conditions.