European Medicines Agency
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The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.
Roughly parallel to the U.S. Food and Drug Administration (FDA), but without FDA-style centralization, the EMEA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies. The hope is that this plan will not only reduce the $350 million annual cost drug companies incur by having to win separate approvals from each member state but also that it will eliminate the protectionist tendencies of states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EU is currently the source of about one-third of the new drugs brought onto the world market each year.
Based in London, the EMEA was born after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products set up in 1977 and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees.
Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 as the European Medicines Agency, it has retained the acronym EMEA throughout.
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[edit] Operations
EMEA operates as a decentralized scientific agency (as opposed to a regulatory authority) of the EU and is responsible for the protection and promotion of human and animal health, specifically through the coordination of evaluation and monitoring of centrally authorized products and national referrals, developing technical guidance and providing scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics/ TEPs and herbal medicinal products. The agency is composed of the Secretariat (management board), scientific committees (one each for human, veterinary and herbal medicinal products as well as orphan drug designations) and scientific working parties. EMEA is organized into four units: human medicine, veterinary medicines and inspections; communications and networking, and administration. A Management Board provides administrative oversight to the EMEA: including approval of budgets and plans, and selection of Executive Director. The Board includes two members per member state, two from the EEC, and two from the European Parliament.
For products eligible for or requiring central approval, a pharmaceutical company submits an application for a marketing authorisation 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 European Commission to be transformed into a marketing authorisation valid for the whole of the European Union. The EMEA's Committee on Orphan Medicinal Products (COMP) administers the granting of orphan drug status. The fourth committee at EMEA is the Committee on Herbal Medicinal Products (HMPC). It assists the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework.
Since July 2007, there is also a new committee dealing with the new paediatric legislation in Europe (the PDCO). From July 2008, all new applications for the marketing authorisation of new pharmaceutical products will have to either include data from paediatric studies (previously agreed with the PDCO), or to demonstrate that a waiver or a deferral of these studies has been obtained by the PDCO. From January 2009, this obligation will extend to most variations of already authorised products (for example, for new therapeutic indications).
The majority of existing medicines throughout the European Union's member states remain authorised nationally, but the majority of genuinely novel medicines are authorised through the EMEA.
The Agency has a staff of about 500, and decentralizes its scientific assessment of medicines by working through a network of about 3500 experts throughout the EU. EMEA draws on resources of National Competent Authorities (NCAs) of EU Member states.
The CHMP and CVMP are obliged by the Regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. This compares well with the average of 500 days taken by the U.S. FDA.
[edit] See also
- EudraCT
- EudraLex
- EUDRANET
- EudraPharm
- EudraVigilance
- European Clinical Research Infrastructures Network
- European Forum for Good Clinical Practice (EFGCP)
- European Federation of Pharmaceutical Industries and Associations
- European and Developing Countries Clinical Trials Partnership
- Ethics Committee
- ICH
- Frances Oldham Kelsey
- Medicines and Healthcare products Regulatory Agency (MHRA, UK)
- Qualified Person
- Regulation of therapeutic goods
- Supplementary protection certificate (SPC)
[edit] References
- McCormick, John (2004). The European Union: Politics and Policies. Boulder, Colo: Westview Press. ISBN 0-8133-4202-3.
[edit] External links
- European Medicines Agency
- Committee for Medicinal Products for Human Use (CHMP)
- Committee for Medicinal Products for Veterinary Use (CVMP)
- Head of Agencies
- The Rules Governing Medicinal Products in the European Union - EudraLex
- European Economic Area (EEA)
