The Clinical Trial 2004 Regulation will remain in force after 1 January 2021. The UK regulations may be modified to make sure they are adapted to meet the post Brexit requirements such as electronic submission and importation of an investigational medicinal product (IMP). As a result, the new EU Clinical trial Regulation (CTR) 536/2014 will not be implemented in the UK.
At the end of the Brexit transition period the UK are working towards maintaining a robust process in clinical trials regulation. UK Clinical Trial Applications (CTAs) will continue to be authorised by the Medicines and Healthcare product Regulatory Agency (MHRA) and UK Ethics Committee (EC). Thus, the UK’s ability to participate in multinational trials will not change. Existing clinical trial approvals in the UK will continue to apply and there will be no requirement to re-apply.
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