Status of the GCP guidelines in Europe.

Two key factors are of main importance for the development of a common GCP legislation in the Member States of the European Community: 1) July 1991, Enforcement of the EEC Note for Guidance: "Good Clinical Practice for Trials on Medicinal Products in the European Community". This enforcement was setting into operation GCP guidelines which were, however, not yet legally binding at that time. 2) January 1992, Enforcement of EEC Commission, Directive 91/507/EEC: Analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. By this enforcement the EEC Member States were obliged to bring into force the laws, regulations and administrative provisions necessary to comply with the Directive which requests--besides others--all clinical trials to be designed, implemented and recorded in accordance with GCP. Facing the different national regulations covering clinical trials already being in force at that time, some of the European countries are considered to already be in compliance with EEC-GCP. In other countries, however, the Directive causes situations in which EEC-GCP is more demanding than the existing legislation or even contradictory. Country by country this has to be regulated soon by appropriate measures of the legislators in order to establish a uniform standard which will assure clinical trials to be internationally acceptable. Only recently the CPMP introduced the requirement for a "Compliance with GCP" Statement as an indispensable part of the Clinical Expert Reports in registration documentations. Even more than in legislation, there is a lack of inspections in clinical trials by health authorities in most European countries.(ABSTRACT TRUNCATED AT 250 WORDS)