January 2022: MHRA Proposal for Legislative Changes for Clinical Trials

On 17 January 2022, MHRA UK launched eight weeks of public consultation for the UK clinical trial legislations. The proposal invites views on various parameters including research transparency and the clinical trial approval process.

In line with the Make it Public strategy, proposal for a ‘requirement’ in the legislature for trial registration, summary results posting within 12 months of the end of the trial, and sharing trial findings with participants have been discussed. Views on the response and timelines to MHRA queries, decisions, and other responses applicable as per the newly introduced Combined Review have also been called for. Detailed guidance can be accessed here.