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Simple, Safe And Transparent(?): Preliminary Reflections on the Proposal for a New EU Regulation of Clinical Trials

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.