Original Articles

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview


Abstract


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.

Keywords


Europe; human experimentation; legislation

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