Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what assessment his Department has made of whether the UK not being part of the Clinical Trials Regulation coming into effect in 2019 will be able to take part in such trials after the UK leaves the EU.

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.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and National Health Service have been working towards implementation of the new European Clinical Trials Regulation (CTR) since it was agreed in 2014. The application date of the CTR across the EU will be set by the European Commission. The current regulatory approval legislation will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approval.