european medicines agency

The European Medicines Agency (EMEA) is a 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 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 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 betwork 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.

European Medicines Agency

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