The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. A satellite composite image of Europe Europe is the worlds second-smallest continent in terms of area, with an area of 10,600,000 km² (4,140,625 square miles), making it larger than Australia only. ... A medication is a licenced drug taken to cure or reduce symptoms of an illness or medical condition. ...

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. The United States of America — also referred to as the United States, the U.S.A., the U.S., America, the States, or (archaically) Columbia—is a federal republic of 50 states located primarily in central North America (with the exception of two states: Alaska and Hawaii). ... The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ... Centralization is the process by which the activities of an organization, particularly those regarding decision-making, become concentrated within a particular location and/or group. ... 1995 (MCMXCV) was a common year starting on Sunday of the Gregorian calendar. ... Look up drug in Wiktionary, the free dictionary. ... Protectionism is the economic policy of protecting a nations manufacturing base from the effects of foreign competition by means of very high tariffs on imported goods, restrictive quotas, or other means of reducing importation. ... A state is an organized political community occupying a definite territory, having an organized government, and possessing internal and external sovereignty. ...

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. Part of the London skyline viewed from the South Bank London is the most populous city in the European Union, with an estimated population on 1 January 2005 of 7,421,328 and a metropolitan area population of between 12 and 14 million. ... For the album by Ash, see 1977 (album). ...

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 througout.

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 European Commission (formally the Commission of the European Communities) is the executive of the European Union. ...

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 360, and decentralizes its scientific assessment of medicines by working through a computer-linked network of about 3500 experts throughout the EU. 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. Decentralisation (or decentralization) is any of various means of more widely distributing decision-making to bring it closer to the point of service or action. ... The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ...

See also

• Medicines and Healthcare products Regulatory Agency (MHRA)
• Regulation of therapeutic goods
• Supplementary protection certificate (SPC)

The Medicines and Healthcare products Regulatory Agency (MHRA) is a statutory body in the UK that seeks to find and eliminate harm in a medicinal product or device at any stage of its development or use thereby permitting graded* legality of that product (or a licence). ... The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. ... In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, patent-like, intellectual property right. ...

External links

• European Medicines Agency
• Head of Agencies