The EMEA and regulatory control of (bio)pharmaceuticals within the European Union

Abstract

Over the past 10–15 years a substantial body of harmonizing pharmaceutical legislation has been adopted by all constituent countries of the European Union. This has facilitated the creation of a common, European-wide system for the authorization and subsequent supervision of medicinal products. Central to this was the creation of the European Agency for the Evaluation of Medicinal Products (the European Medicines Evaluation Agency, EMEA). The EMEA, which became operational in February 1995, is charged with managing and coordinating the new drug approval system within the European Union. This new approval system provides for the evaluation of any new product marketing application via one of two routes; a “centralized” route mandatory for all products of biotechnology, and a “decentralized” route. Despite the inevitable teething problems, the EMEA has proven itself efficient. Within its first three years of operation, it has facilitated the granting of 52 European-wide marketing authorizations, of which 23 were products of biotechnology. By and large, the EMEA has now gained the confidence of both the European pharmaceutical industry and the various national regulatory authorities within each EU member state.