Privatsphäre-Einstellungen

Durchführung klinischer Prüfungen

EU-Richtlinie zur Durchführung von klinischen Prüfungen am 1. Mai 2001 in Kraft getreten

Prof. Dr. Barbara Sickmüller a, Dr. Elmar Honold a und Dr. Susanne Becker b

Bundesverband der Pharmazeutischen Industrie e.V. a, Frankfurt/Main, und ICON Clinical Research b, Langen

  Conduct of Clinical Trials

Entry into force on 1st May 2001 of the EU Directive on the conduct of clinical trials

The final version of the European Directive on the conduct of clinical trials has been published in the Oficial Journal of the European Communities on 1st May 2001 (L 121/34). Thereby "Directive 2001/20/EC of the European Parliament and of the Council of 4th April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use" has enterd into force on the same day. The current version has been adopted by the Council of the Eropean Union and the European Parliament together in December 2000. The EC Member States must adopt before 1st May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The provisions must be applied at the latest with effect from 1st May 2004. It is further provided in the Directive that the Commission in cooperation with the European Agency for the Evaluation of Medicinal Products shall establish so-called "Notes for Guidance". In this context it can be referred to preliminary work of the Member States. As in previous years the pharmaceutical industry will strongly participate in the discussion on the implementation.