EMEA (European Medicines Agency)

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

The EMEA began its activities in 1995, when the European system for authorising medicinal products was introduced, providing for a centralised and a mutual recognition procedure. The EMEA has a role in both, but is primarily involved in the centralised procedure. Where the centralised procedure is used, companies submit one single marketing authorisation application to the EMEA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorisation valid for the whole of the European Union.

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 coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.

The EMEA is headed by the Executive Director and has a secretariat of about 360 staff members in 2004. The Management Board is the supervisory body of the EMEA, responsible, in particular, for budgetary matters.

In 2001, the Committee on Orphan Medicinal Products (COMP) was established, charged with reviewing designation applications from persons or companies who intend to develop medicines for rare diseases (so-called ‘orphan drugs’). The Committee on Herbal Medicinal Products (HMPC) was established in 2004 and provides scientific opinions on traditional herbal medicines.