European Commission: Assessment of the functioning of the \"Clinical Trials Directive” 2001/20/EC - Public consultation paper

Requirements for the conduct of clinical trials in the EU are provided for in the “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”