About EMEA - Structure
European Medicines Agency
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 EEAEFTA
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, autoimmune
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 abovementioned
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
mediumsized
enterprises (SMEs).
- Five scientific committees, composed of members of all EU and EEAEFTA
states, 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) and the
Paediatric Committee (PDCO). A sixth scientific committee – the Committee for Advanced
Therapies (CAT) – will be established at the end of 2008.
- The Agency brings together the scientific resources of some 40 national competent authorities in
30 EU and EEAEFTA
countries in a network of over 4,000 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 470 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 noncentralised authorisation procedures.