The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.

VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines

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

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

The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines

This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

HumanRegulatory and procedural guidancePaediatricsResearch and development
EventHumanResearch and development