The European Medicines Evaluation AgencyBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7028.394 (Published 17 February 1996) Cite this as: BMJ 1996;312:394
- Andrew Herxheimer
- Chairman, International Society of Drug Bulletins 9 Park Crescent, London N3 2NL
Moving towards more transparent drug registration systems
The European Medicines Evaluation Agency (EMEA) opened its doors for business just over a year ago and, despite a shaky start, is making progress in implementing the new European drug registration system. The aim is to give patients quick access to innovatory new drugs, to facilitate the free movement of drugs within the European Union, and to provide rigorous scientific evaluation of new products. The system also aims to encourage cooperation, communication, transparency, and confidence among regulators, industry, health professionals, and consumers.
The system uses two licensing procedures: a centralised procedure via the agency, which is now compulsory for new biotechnology products, although companies can request it for other drugs as well; and a decentralised procedure, which applies to most conventional products and is based on the previous system of mutual recognition of national authorisations. A product licence obtained in one …