Clinical trials: Initial Appraisal of the European Commission's Impact Assessment

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment on the Revision of the Clinical Trials Directive 2001/20/EC (SWD (2012) 200, SWD (2012) 201 (summary)) accompanying the Commission Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM (2012) 369).