POST - Parliamentary Office of Science and Technology

Regulating Clinical Trials

Published Monday, October 2, 2017

This POSTnote describes the new EU Clinical Trial Regulation and the timetable for its implementation and examines its likely impact on the regulation of clinical trials in the UK post-Brexit.

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Clinical trials are essential to establish the safety and efficacy of medicines and are strictly regulated in the EU. The current EU regulatory framework is due to be replaced by a new EU Clinical Trial Regulation in 2019. This POSTnote examines how this may effect the UK healthcare industry, including issues around clinical trial transparency. It also examines options for UK regulation of clinical trials post-Brexit, including a brief description of the more general issues facing UK patients and clinical researchers post-Brexit. 

POSTnotes POST-PN-0561

Authors: Peter Border; Samuel Bunce

Topics: EU law and treaties, Health staff and professions, Medicine, Research and innovation, Science

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The Parliamentary Office of Science and Technology produces independent, balanced and accessible briefings on public policy issues related to science and technology.