European Medicines Agency (EMA)

The European Union’s organization aimed at protecting and promoting public health, including the responsibility of evaluating and supervising medical products. The EMA includes the following committees and groups:

CHMP (Committee for Medicinal Products for Human Use): prepares the EMA’s opinion on all questions related to medicines for human use.

CMDh (Coordination Group for Mutual Recognition and Decentralized Procedures, human): examines cases of disagreement between Member States related to marketing authorization and promotes harmonization of marketing authorizations in the EU.

PRAC (Pharmacovigilance Risk Assessment Committee): advises the CMDh and the CHMP on the assessment of pharmacovigilance data after the medicinal product’s authorization.