Go directly to the content here!

Eurecnet - Legislation: European Union

Legislation: European Union

4 April 2001: In the "Clinical Trials Directive" (Directive 2001/20/EC) the European Parliament and the Council provide requirements for the conduct of clinical trials in the EU.
8 April 2005: The Clinical Trials Directive was further substantiated by the "Good Clinical Practice Directive" (Commission Directive 2005/28/EC) which defines guidelines and principles for good clinical practice with regard to investigational medicinal products for human use.
16 April 2014: The "New Regulation No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC" was adopted. The new regulation became effective on 16 June 2014 and will apply no earlier than 28 May 2016.

<- Home

Contact: eurec@eurecnet.org