In a joint analysis, the Association Internationale de la Mutualité, the Medicines in Europe Forum, the International Society of Drug Bulletins and Wemos argue that, with its proposed new Regulation on clinical trials, the European Commission has overlooked important improvements provided by Directive 2001/20/EC for the protection of subjects enrolled in clinical trials. Most notably, the proposed Regulation could seriously undermine Member States' subsidiarity on ethical matters.
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