The European Medicines Agency (EMA) is the regulatory authority of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use. It coordinates the centralized marketing authorization procedure, which grants a single marketing authorization valid across all EU member states, and plays a key role in the regulation of biologics, gene and cell therapies, biosimilars, and orphan medicines through specialized committees such as the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT).
