The European Medicines Agency (EMA) is the European Union’s decentralized agency responsible for the scientific evaluation, authorization, and supervision of medicines for human and veterinary use. Headquartered in Amsterdam, it coordinates a network of national competent authorities and expert committees to assess quality, safety, and efficacy, and to manage post‑marketing safety through pharmacovigilance. The EMA’s centralized procedure can grant a single marketing authorization valid across EU/EEA member states.
For the chemical and pharmaceutical value chain, the EMA sets and interprets standards for active pharmaceutical ingredients and excipients, evaluates chemistry, manufacturing and controls (CMC) data, supports GMP/GDP oversight and inspections in cooperation with national authorities, and issues guidance on impurities and quality risks (including nitrosamines). It operates key regulatory platforms such as EudraVigilance for safety reporting and the Clinical Trials Information System (CTIS), and provides scientific advice and pathway designations (e.g., orphan, pediatric, and advanced therapies) that shape development and manufacturing requirements across Europe.
