title: [Registration of new medicinal products in Europe].
abstract: In 1993 the European Medicines Agency (EMEA) for the registration of new medicinal products in Europe was founded. The agency started its work in 1995 and is supported by five scientific committees, the most important one being the Committee for Medicinal Products for Human Use (CHMP). At the same time two procedures for the registration of medicinal products in Europe were put into effect, the centralized procedure and the mutual recognition procedure. The centralized procedure is obligatory for all biotechnology-derived medicinal products, medicines for HIV/AIDS, cancer, diabetes, neurodegenerative diseases, and orphan medicines intended for the treatment of rare diseases. All medicinal products in the centralized procedure are evaluated by the CHMP. All other medicinal products are registered according to the mutual recognition procedure, where a first registration in an EU member state is granted and then extended to other member states. Between 1995 and 2004 there were 243 approvals in the centralized procedure, 20% regarding drugs for the treatment of cancer. The new procedures have harmonized and accelerated the registration of medicinal products in Europe to a remarkable extent.
authors.affiliation: Institut für Pharmakologie, Zentrum für Biomolekulare Medizin und Pharmakologie, Medizinische Universität Wien, Osterreich. ernst.singer@meduniwien.ac.at
authors.forename: Ernst
authors.initials: E
authors.lastname: Singer
mesh_terms: D017277:Drug Approval / Q000458:organization & administration*; D005062:European Union; D005858:Germany; D033161:Government Regulation; D019983:Guideline Adherence / Q000458:organization & administration*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D017410:Practice Guidelines as Topic; D012042:Registries / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations