European Union
European Medicines Agency (EMA) · Europe
Executive summary
The European Union operates a multi-tier authorisation system administered by the European Medicines Agency (EMA) for centrally-authorised products and by national competent authorities (NCAs) for nationally, mutually-recognised, and decentralised authorisations. The Centralised Procedure is mandatory for biotechnology-derived products, advanced therapies (ATMPs), orphan medicines, and products for HIV/AIDS, cancer, neurodegenerative disease, diabetes, autoimmune disease and viral disease — and optional for new active substances of significant innovation. Authorisation under the Centralised Procedure yields a single EU-wide marketing authorisation valid in all 27 EU Member States plus Iceland, Liechtenstein and Norway (EEA). The Clinical Trials Regulation (Regulation (EU) No 536/2014) became fully applicable on 31 January 2022 and ended the transitional period on 31 January 2025, replacing the Clinical Trials Directive entirely. All clinical trial applications now go through the Clinical Trials Information System (CTIS). The new EU HTA Regulation (Regulation (EU) 2021/2282) applies Joint Clinical Assessments to all new oncology medicines and ATMPs from 12 January 2025, with rare diseases joining in 2028 and all centralised products from 2030. The pharmaceutical legislation is being revised under the EU Pharmaceutical Package proposed by the Commission in April 2023 — the most significant overhaul in two decades — currently in trilogue with adoption expected in 2026.
About the authority
EMA is a decentralised EU agency based in Amsterdam (relocated from London in 2019 post-Brexit). Scientific evaluation is conducted by the Committee for Medicinal Products for Human Use (CHMP); paediatrics by the PDCO; orphan designations by COMP; ATMPs by CAT; pharmacovigilance by PRAC; and herbal medicines by HMPC. The European Commission grants the marketing authorisation following a positive CHMP opinion (binding on Member States). The Heads of Medicines Agencies (HMA) coordinates the activities of the 27 NCAs.
Reliance & recognition
EMA does not formally rely on third-country approvals. However, work-sharing exists with FDA (Cluster meetings, parallel scientific advice), Health Canada (CHMP–HC parallel review pilots), and PMDA (Cluster). Article 58 Regulation (EC) 726/2004 enables CHMP scientific opinion on medicines intended exclusively for markets outside the EU (used for WHO prequalification), since 2024 known as EU-Medicines for All (EU-M4all).