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August 8, 2018updated 11 Jul 2022 9:55am

MHRA outlines post-Brexit clinical trials regulation

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has outlined the functioning of clinical trials regulation after the UK leaves the European Union (EU) in March next year.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has outlined how clinical trials regulation will function after the UK leaves the European Union (EU) in March next year.

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A Brexit implementation period will commence between the UK and EU on 30 March 2019 and will lapse on 31 December 2020. During this period, the UK will not be a member state of the Union, but will have market access on the existing terms.

The EU is planning to implement a new Clinical Trials Regulation (CTR) in 2020, which would be applicable to the UK under the terms of the implementation period.

This CTR is intended to optimise application process and assessment procedure, simplify reporting, and offer only one portal for all EU clinical trials. The UK was also involved in devising the new rules.

In case the new legislation does not come into effect during the implementation period, the UK plans to retain alignment with parts of the CTR that are under its control.

“It is in the interest of patients and the life sciences industry internationally for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data.”

However, after the implementation period, the UK will not be able to use a shared central IT portal and participation in the single assessment model, unless they come to an agreement with the EU.

A statement from MHRA read: “It is in the interest of patients and the life sciences industry internationally for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data, even if our precise relationship with the EU will by necessity change.

“No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment.”

The announcement on post-Brexit clinical trial regulation follows a recent confirmation by British Medical Association (BMA) that the UK is considering stockpiling of medical supplies in case of a no-deal Brexit.

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