In July 2012 the European Commission submitted the proposal titled “Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”. The goal of the Regulation is to harmonise the clinical trials of medicinal products on humans in Europe and to reduce the complications involved in conducting them.
According to frequently expressed criticisms, the proposal falls short of the safeguarding provisions that until now have been in effect in Germany; this is true regarding established procedural standards as well. The ad hoc statement jointly drafted by Leopoldina, the Union of German Academies and the Germany Academy of Science and Engineering acatech examines some of the ethically problematic aspects of the proposed Regulation that are considered to be of central importance.
Scientific Officer, Department Science - Policy - Society
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