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European Medicines Agency
EU centralised authority for human & veterinary medicines.
Regulatory scope
Product categories regulated
Small moleculesBiologicsBiosimilarsVaccinesCell therapyGene therapyATMPsCombination productsRadiopharmaceuticals
Submission types
CTAMAAOrphan drug applicationBiosimilar applicationPre-submission meeting
Therapeutic areas
OncologyRare diseasesInfectious diseasesNeurologyImmunologyVaccines
Inspection programs
GMPGDPGLPGCPPharmacovigilanceData integrity
Digital & transparency
Online submission portaleCTD supportedPublic assessment reportsGuidance databaseInspection databasePharmacovigilance databaseOpen-data portal
EMA
European Medicines Agency
Supranational agency · Netherlands
Live record · illustrative seed data · scores deterministic, rules-based — not AI.