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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
HumanEarly accessResearch and developmentScientific guidelines
HumanCompassionate useEarly accessRegulatory and procedural guidanceResearch and development
NewsHumanCOVID-19Early accessResearch and developmentScientific advice
NewsHumanEarly accessQuality of medicinesResearch and development
EventHumanAdvanced therapiesEarly accessRegulatory and procedural guidanceInnovationMedicinesResearch and developmentScientific guidelines
HumanEarly accessRegulatory and procedural guidanceResearch and development
The European Medicines Agency's scientific guidelines on biosimilar medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
HumanBiosimilarsRegulatory and procedural guidanceResearch and developmentScientific guidelines