![]() If the Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states.Ĭommittees Medicinal products for human use Ī single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP). The Agency decentralises its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The Board includes one representative of each of the 27 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of executive director. The Secretariat is organised into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs, paediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties. The agency is composed of the Secretariat (ca. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products. More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors. The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and 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 agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union, relocating to Amsterdam in March 2019. The EMA was founded after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. ![]() ![]() The hope was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA). The European Medicines Agency ( EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. ![]()
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