Report from the UK Government - ‘A bold new regulatory framework for the UK’

The UK Government’s Taskforce on Innovation, Growth and Regulatory Reform have published a report on post-Brexit UK regulatory reforms, which includes information about the objectives for the regulation of UK clinical trials.

The report can be found here, with the clinical trial specific information from Page 67.

Key takeaways include an intention to repeal the EU Clinical Trials Directive (as per the Medicines and Devices Act that is currently progressing), the establishment of a UK Regulatory Innovation Hub, simplifying consent processes and reforms for Clinical Trials Units (CTUs).

There is also information contained concerning reforms to data regulation, which of course would also impact upon clinical trials and other clinical research, and an increase in streamlined processes for AI research.