About EMEA - Structure

European Medicines Agency

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The European Medicines Agency (EMEA) is a decentralised body of the European Union with
headquarters in London. 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.

• The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit a single marketing authorisation application to the EMEA. Once granted by the European Commission, a centralised (or ‘Community’) marketing authorisation is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway).
• All medicinal products for human and animal use derived from biotechnology and other hightechnology processes must be approved via the centralised procedure. The same applies to all human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, as well as to all designated orphan medicines intended for the treatment of rare diseases. Similarly, all veterinary medicines intended for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals have to go through the centralised procedure.
• For medicinal products that do not fall under any of the above-mentioned categories, companies can submit an application for a centralised marketing authorisation to the EMEA, provided the medicinal product constitutes a significant therapeutic, scientific or technical innovation, or the product is in any other respect in the interest of patient or animal health.
• The safety of medicines is monitored constantly by the Agency through a pharmacovigilance network. The EMEA takes appropriate actions if adverse drug reaction reports suggest changes to the benefit-risk balance of a medicinal product. For veterinary medicinal products, the Agency has the responsibility to establish safe limits for medicinal residues in food of animal origin.
• The Agency also plays a role in stimulating innovation and research in the pharmaceutical sector. The EMEA gives scientific advice and protocol assistance to companies for the development of new medicinal products. It publishes guidelines on quality, safety and efficacy testing requirements. A dedicated office established in 2005 provides special assistance to small and medium-sized enterprises (SMEs).
• Six scientific committees, composed of members of all EU and EEA-EFTA states, some including patients’ and doctors’ representatives, conduct the main scientific work of the Agency: the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicinal Products (COMP), the Committee on Herbal Medicinal Products (HMPC), the Paediatric Committee (PDCO) and the Committee for Advanced Therapies (CAT).
• The Agency brings together the scientific resources of over 40 national competent authorities in 30 EU and EEA-EFTA countries in a network of over 4,500 European experts. It contributes to the European Union’s international activities through its work with the European Pharmacopoeia, the World Health Organization, and the ICH and VICH trilateral (EU, Japan and US) conferences on harmonisation, among other international organisations and initiatives.
• The EMEA is headed by the Executive Director and has a secretariat of approximately 530 staff members in 2008. The Management Board is the supervisory body of the EMEA, responsible, in particular, for budgetary matters.
• The Agency is also involved in referral procedures relating to medicinal products that are approved or under consideration by Member States in non-centralised authorisation procedures.