The regulation of medicines throughout Europe has undergone significant change since the first pharmaceutical Directive in 1965. 1995 will bring the next major stage in this evolution with the introduction of the so-called « Future System proposals ».
These will see the creation of the EMEA (the European Medicines Evaluation Agency), the introduction of a Centralized Procedure, applicable to a small number of innovative drugs, and a Decentralized Procedure, based on mutual recognition of licences granted by existing control authorities in other EC countries.
The regulation of medicines in the United Kingdom has also changed considerably since the establishment of the Medicines Control Agency in 1989.
This article looks at the new licensing arrangements for Europe and the development of medicines control in the UK over the last few years.
Mots-clés Pascal : Régulation, Médicament, Europe, Législation, Autorisation, Royaume Uni, Pharmacovigilance, Administration publique, Système centralisé, Système décentralisé, Autorisation mise sur marché
Mots-clés Pascal anglais : Regulation(control), Drug, Europe, Legislation, Licence procedure, United Kingdom, Pharmacovigilance, Civil service, Centralized system, Decentralized system
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0216048
Code Inist : 002B30A08. Création : 09/06/1995.