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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.
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).
The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals.
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.
The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.