What is Clinical Trials Directive?

The Clinical Trials Directive is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.

The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.