title: Pre-marketing authorisation submission assessments in Europe.
abstract: The publication of the European Directive 2001/20/EC on the implementation of good clinical practice in trials has far-reaching consequences on the type of data to be submitted for evaluation by the competent authorities and ethics committees, in order to initiate a clinical trial with one or more site(s) in Europe. The ensuing commission guidelines and guidance provided by Member States at the time of national implementation describe the content of an application for a 'clinical trial authorisation' and its maintenance. This review discusses some of the implications for pharmaceutical companies submitting requests for clinical trial authorisations.
authors.affiliation: Sanofi Pasteur, Marcy l'Etoile, France. Lyn.morgan@sanofipasteur.com
authors.forename: Lyn
authors.initials: L
authors.lastname: Morgan
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D005060:Europe; D005062:European Union; D004364:Pharmaceutical Preparations / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations