EUROPEAN MEDICINES AGENCY

The European Medicines Agency (EMEA) contributes to the protection of public and animal health by ensuring that medicines for human and veterinary use are safe, effective and of high quality. Bringing together the scientific resources of the 25 EU Member States in a network of more than 40 national competent authorities the EMEA coordinates the evaluation and supervision of medicines throughout the European Union. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.

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 are sufficiently proven, it adopts a positive opinion, which is sent to the Commission to be transformed in a single market authorisation valid for the whole of the European Union.

In 2001, the Committee on Orphan Medicinal Products (COMP) was established, reviewing designation applications from persons or companies who intend to develop medicines for rare diseases, so-called ‘orphan drugs’. From the end of 2004 onwards a new Committee on Herbal Medicinal Products (HMPC) will provide scientific opinions on traditional herbal medicines. The scientific work of the EMEA and its committees is underpinned by a network of 3 500 European experts.

Ten years after its inauguration, the EMEA is implementing new legislation that will significantly broaden the mandate of the Agency. In addition to a number of organisational changes, Regulation (EC) No 726/2004 (which replaces Regulation (EEC) No 2309/93) gives the Agency greater responsibilities, in particular to speed access by patients to new medicines and improve the provision of information to all users of medicines.

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