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
HumanVeterinaryData on medicinesRegulatory 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