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www.fdanews.com/articles/186573-uk-plans-to-stick-with-eu-clinical-trial-regulations-post-brexit

UK Plans to Stick With EU Clinical Trial Regulations Post-Brexit

April 26, 2018

The UK government aims to stay up-to-date with EU changes for clinical trial procedures amid uncertainties over next March’s implementation of Brexit.

The new EU clinical trials regulations were initially meant to be implemented in October 2018, but were delayed by the European Medicines Agency until 2019 at the earliest due to technical difficulties. The agency has called the modernization process its most ambitious IT system requirement in the last decade.

Baroness Annabel MacNicoll Goldie of the UK’s House of Lords clarified the government’s position on future UK clinical trials regulation, giving “the strongest possible reassurance” that if the EU clinical trials regulations are implemented in March 2020, they will apply to the UK.

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