PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...

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.