文章基本信息

标题：Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview
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作者：Carlo Petrini
期刊名称：Annali dell'Istituto Superiore di Sanita
印刷版ISSN：0021-2571
出版年度：2014
卷号：50
期号：4
页码：317-321
DOI：10.4415/ANN_14_04_04
出版社：Editrice Kurtis Srl
摘要：For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an over- view of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination.
关键词：Europe ; . human experimentation ; . legislation