Assessment of the functioning of the "Clinical Trials Directive"
In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on "Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector", the Commission announced that an assessment would be made of the application of the Clinical Trials Directive.
This assessment would consider, in particular, various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account.
A public consultation document along this line is published here. Interested parties are invited to comment by 8 January 2010.