Clinical Trial Regulation Seeks Uniformity Across EU
February 19, 2014, 5:25 PM EST
Law360, New York (February 19, 2014, 5:25 PM EST) -- On Dec. 20, 2013, the General Secretariat of the Council of the European Union released the revised proposal for a regulation, the “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,” to the European Parliament.
The path to new clinical trials regulation was initiated on July 17, 2012, when the European Commission adopted a draft proposal for a clinical trials regulation. The provisional agreement reached by the EU Committee of Permanent Representatives marks...