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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article1 June 2011European Medicines Agency

ENCePP Reponse to the Revision of the CT Directive

ENCePP has submitted a response to the European Commission’s public consultation on the concept paper on the revision of the ‘Clinical Trials Directive’ 2001/20/EC. The key message from ENCePP is in relation to an amended definition of a non-interventional trial and a link to the ENCePP contribution is provided below.
Meanwhile, looking to the current definition, the interpretation of current clinical practice and the role of ethics committees for non-interventional studies will be elaborated in a position paper that is being developed by ENCePP on the interpretation of the definition of a non-interventional trial within Directive 2001/20/EC. The final position paper relating to the current legal framework will be available in Q3 2011.

For more information see:

- Commission Concept Paper

- ENCePP Response


Publication date
1 June 2011
European Medicines Agency