MHRA clarifies post-Brexit clinical trials rules

Pharma Times

8 August 2018 - The MHRA has clarified how the UK’s clinical trials rules will function in partnership with the EU after Britain leaves the Union in March next year.

“As part of exit negotiations, MHRA is working to ensure that we continue to have the best possible environment in which to support clinical trials,” the agency said. “Our overall aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines.”

As well as releasing a technical document giving technical guidance on Brexit implementation, in a statement the agency said that during the Brexit transition period, which will run from 30 March 2019 till 31 December 2020, EU rules and regulations will remain in place in order to provide continuity and certainty to businesses and citizens. Specifically, the EU’s new Clinical Trials Regulation is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

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Michael Wonder

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Michael Wonder