About EUREC
National Information
Services
This network has received funding from the 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. |