European agency of the drugs

The European Agency of the drugs - in English:
European Medicines Evaluation Agency ( EMEA ) is a Community Agence creates in 1995. It is based in London, in England.

It is the European agency which evaluates, coordinates and supervises the development of new the Médicament S in the European Union.

Its equivalent in the United States is FDA ( Food and Drug Administration ).

Description

Its main mission is the protection and the promotion of the public health and animal through the evaluation and the supervision of the drugs of human and veterinary use.

The EMEA is in charge of the scientific evaluation of the European requests for authorization of marketing of the drugs (centralized procedure). When he is resorted to the centralized procedure, the companies subject to the EMEA only one request for marketing authorization.

All the drugs of human use and veterinary surgeon derived from the Biotechnology and other high technologies must be approved via the centralized procedure. The same applies to all the drugs intended for the treatment of the infections of the VIH/Sida, of the Cancer, the Diabète or the neurodégénératives Maladies and for all the orphan drugs indicated and intended for the treatment of the rare diseases. In the same way, all the veterinary medicinal products intended to improve the performances in order to promote the growth of the treated animals, or to increase the output by the treated animals, must pass by the centralized procedure.

With regard to the drugs concerned with none the above-mentioned categories, the companies can subject a request for marketing authorization centralized to the EMEA provided that the drug constitutes a therapeutic innovation, scientific or technical major or that it is of an interest for the human health or animal.

The safety of the drugs is followed permanently by the Agency thanks to a network of pharmacovigilance. Indeed, it takes appropriate measures when reports/ratios of undesirable effects suggest changes on the level of balance benefit/risk of a drug. With regard to the veterinary medicinal products, the Agency is charged to define sure limits for the medicamentous residues contained in food of animal origin.

The Agency also plays a part in the promotion of the innovation and research in the Drug company. The EMEA provides to the companies of the scientific opinions and an assistance on the level of the protocol for the development of new drugs. It also publishes directives on the requirements as regards tests of quality, safety and effectiveness. A dedicated office created in 2005 provides a special assistance to the small and medium-size companies (SME).

In 2001, the committee of the orphan drugs (COMP) was created and is since then in charge of the examination of the requests for designation deposited by natural persons or morals wishing to develop drugs intended for the treatment of rare diseases, the “orphan drugs”. The committee of the drugs containing plants (HMPC) was created in 2004 and gives scientific opinions on the traditional drugs containing plants.

The Agency polarizes the scientific resources with more than 40 qualified national authorities in 30 countries of the European Union and EEA - EFTA within a network more than cash 4000 European experts. It contributes to the international activities of the European Union by its work with the European Pharmacopeia, the trilateral World Health Organization and conferences ICH and VICH (European Union, Japan and the United States) on the harmonization, to quote only some of the organizations and international initiatives.

Organization of the Agency

The EMEA is directed by the executive director and is equipped with a secretariat of approximately 440 people since 2007. The board of directors is its body of supervision, in particular charged, of the budgetary matters.

External bonds

Internet site of the EMEA (in English)

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