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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
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