EU Directive 2001/20/EC
Area of Application
Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products ("IMPs").
Requirements for the conduct of clinical trials in the EU are provided for in "Directive 2001/20/EC of the European Parliament and of the Council of 4 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.
On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. The Regulation entered into force on 16 June 2014 but will apply no earlier than 28 May 2016.