NHS European Office

The new EU Clinical Trials Regulation: how NHS research and patients will benefit


30 / 09 / 2014

A new EU law will address shortcomings of the existing EU Clinical Trials Directive, which contributed to a significant decrease in the number of clinical trials conducted in the UK. This briefing outlines the key changes made by the new EU Regulation on clinical trials and what they mean for the NHS.

Clinical trials are an essential part of the development of new medicines, and also have a role in the improvement of medical care more generally.

The changes that the new EU law will bring are timely in light of the increasing importance of clinical research in the NHS and the establishment of academic health science networks.

The new law will in particular allow for the speeding up of the process for authorising new clinical trials and reduce the administrative burden associated with the conduct of these studies.

This briefing will be of interest for all involved in clinical research, including senior board members. Given the importance of the issue to the innovation agenda, it will also be of interest to academic health science centres and networks.

View the accompanying infographic.

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