Article

The EU clinical trial regulation: Are we ready for its implementation?

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Abstract

The new EU Clinical Trial Regulation1 was adopted on 16 April 2014 and published in the Official Journal on 27 May 2014. It will replace the current EC Directive 2001/20, which has governed clinical trials in the EU for the past ten years or so. While for the most part this change is welcomed by industry, there are still some ambiguities and uncertainties surrounding aspects of the new Regulation. This article offers an industry viewpoint of perceived potential problems, and raises questions that may need clarification prior to implementation. © 2015 The Organisation for Professionals in Regulatory Affairs.

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