EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.

HumanRegulatory and procedural guidancePharmacovigilanceResearch and development

A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).

HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines

The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines