Clinical Trials: EU Countries

Department of Health and Social Care written question – answered on 20th May 2020.

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Photo of Lord Sharkey Lord Sharkey Liberal Democrat

To ask Her Majesty's Government what steps they have taken to ensure UK–EU clinical trials can continue after the end of the transition period, and once the EU Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into effect.

Photo of Lord Bethell Lord Bethell The Parliamentary Under-Secretary for Health and Social Care

The Government is committed to a world-leading regulatory system for clinical trials that allows us to collaborate effectively globally, ensuring the United Kingdom remains one of the best places in the world for science and innovation. At the end of the transition period, clinical trials will continue to be approved at a national level, working to international standards as they are now. The Medicines and Healthcare products Regulatory Agency (MHRA), along with partners across the UK healthcare ecosystem, has taken steps to ensure that all trials including multinational trials can continue seamlessly.

The MHRA, Health Research Authority, ethics services, National Institute for Health Research, National Health Service and devolved administrations have been preparing to implement the forthcoming European Union Clinical Trials Regulation since it was agreed in 2014. The UK will implement those aspects of the regulation which are in the best interests of UK patients, industry, non-commercial researchers and hospitals when it comes into force and this is currently expected during 2022.

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