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...

HumanEarly accessRegulatory and procedural guidanceResearch and development

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
ReferralHuman

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...

HumanVeterinaryCorporateData on medicinesInnovationResearch and development
HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice