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Clinical Trials: EU Law

Question for Department of Health and Social Care

UIN HL12041, tabled on 4 December 2018

To ask Her Majesty's Government whether the EU Clinical Trials Regulation, due to come into effect in 2019, will apply to clinical trials in the UK after Brexit.

Answered on

13 December 2018

The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.

Regarding the EU’s new Clinical Trials Regulation (CTR), the CTR is expected to be implemented during 2020 and would therefore apply to the United Kingdom under the terms of the time-limited implementation period. If the new regulation does not come into force during the implementation period, or in the unlikely event that the UK leaves the EU without a deal, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control.

Answered by

Department of Health and Social Care