Clinical Trials under the New European Regulation: An Update

doi:10.15344/2456-8007/2016/105

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International Journal of Clinical Research & Trials Volume 1 (2016), Article ID 1:IJCRT-105, 1 pages
https://doi.org/10.15344/2456-8007/2016/105

Commentary

Clinical Trials under the New European Regulation: An Update

Andre den Exter

Health law, Erasmus University Rotterdam, Rotterdam, Netherlands

Corresponding Author Details: Dr. Andre den Exter, Health law, Erasmus University Rotterdam, Rotterdam, Netherlands; E-mail: denexter@bmg.eur.nl

Received: 25 January 2016; Accepted: 15 June 2016; Published: 17 June 2016

Citation: den Exter A (2016) Clinical Trials under the New European Regulation: An Update. Int J Clin Res Trials 1: 105. doi: https://doi.org/10.15344/2456-8007/2016/105

Copyright: © 2016 den Exter. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

References

European Commission. 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, July 17, 2012 COM(2012)369 final, p. 2-3
Officially, EU Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Kenter MJH, Cohen AF (2012) Re-engineering the European Union Clinical Trials Directive. The Lancet 379: 1765-1767 [CrossRef] [Google Scholar] [PubMed]
Commission Staff Working Document. Impact assessment report on the revision of the “Clinical Trials Directive” 2001/20/EC, Brussels 17.7.2012 SWD(2012)200 final, vol. I, p. 21-23
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, et al. (2009) Ethical and Scientific Implications of the Globalization of Clinical Research. N ENGL J Med 36: 816-823 [CrossRef] [Google Scholar] [PubMed]
Heringaand Dute, ‘The proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?’ (2013) 4 EJHL 347-362; at 349

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