[The role of the Committee for Medicinal Products for Human Use (CHMP) in the European centralised procedure].
The centralised procedure for marketing authorisation at the European Medicines Agency (EMEA) started more than 10 years ago, offering marketing authorisation for all member states of the European Union in a single procedure. Originally it was a purely optional alternative to the established national procedures; however, its importance has been growing ever since. The introduction of the mandatory scope for several important indications was a crucial step. The increasing importance of the centralised procedure was paralleled by the increasing weight of the EMEA and of the Committee for Human Medicinal Products (CHMP) who is responsible for scientific evaluation in the centralised procedure. This paper describes the basic principles of the centralised procedure including the definitions of the mandatory and optional scope, and how the CHMP works including its responsibility in European referrals that provide a link to national procedures.
Enzmann
Harald
H
Bundesinstitut für Arzneimittel, Kurt-Georg-Kiesinger Allee 3, Bonn, BRD. h.enzmann@bfarm.de
Schneider
C
C
D003299:Cooperative Behavior; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry / Q000458:organization & administration*; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D006801:Humans; D007373:Interinstitutional Relations; D007880:Legislation, Drug; D040541:Marketing / Q000458:organization & administration*; D004364:Pharmaceutical Preparations; D010606:Pharmacy and Therapeutics Committee / Q000458:organization & administration*
D004364:Pharmaceutical Preparations