The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency(EMEA).
The EMA operates as a decentralized scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. It coordinates the evaluation and monitoring of centrally authorized products and national referrals, developing technical guidance and providing scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products.
The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs, pediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties.
Organization
- Directorate
- Human Medicines Development and Evaluation
- Patient Health Protection
- Veterinary Medicines and Product Data Management
- Information and Communications Technology and Administration.
The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of Executive Director.
The Board includes one representative of each of the 28 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients’ organizations, one representative of doctors’ organizations and one representative of veterinarians’ organizations. The Agency decentralizes its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states.