In its Communication of 10th December 2008 on 'Safe, innovative and accessible medicines: a renewed vision-for the pharmaceutical sector' the European Commission announced that an assessment would be made of the clinical trials Directive. In October 2009, the Commission published a Public Consultation Paper regarding the envisaged assessment. After the consultation procedure, the Commission published on 17th July 2012 a 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/ It is not the aim of this contribution to describe the proposed Regulation in its entirety. It is limited on how the proposed Regulation regulates the ethical assessment of clinical trials and the protection of participants in clinical trials compared with the existing rules in the Directive.
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