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Clinical Trials: EU Law

Question for Department of Health and Social Care

UIN 3773, tabled on 15 January 2020

To ask the Secretary of State for Health and Social Care, what his policy is on alignment with the forthcoming EU Clinical Trial Regulation (Regulation (EU) No 536/2014) after the UK has left the EU.

Answered on

24 January 2020

The Medicines and Healthcare products Regulatory Agency (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 United Kingdom will implement those aspects of the regulation which best suits the interests of UK patients, industry, non-commercial researchers and hospitals when it comes into force and this is currently expected during 2022.

Regardless of the terms of our exit, we will ensure that we are at the forefront of clinical trials internationally and that the UK remains a competitive environment in which to conduct clinical trials.

Answered by

Department of Health and Social Care