Question to the Department of Health and Social Care:

To ask His Majesty's Government what are the reasons for the variation between 2019 and 2023 in the time taken for new Clinical Trial Authorisation applications to the Medicines and Healthcare products Regulatory Agency to be assessed.

A combination of factors has resulted in extended timeframes in Medicines and Healthcare products Regulatory Agency (MHRA) assessment of clinical trial applications and amendments, in particular the loss of experienced staff and the need to recruit and train new staff. The MHRA understands the vital importance to patients and the public as well as researchers and developers of efficient clinical trials approvals, and over the summer it has taken urgent action to address delays to clinical trial approval.

Applicants will have seen increased rates of assessment in all key areas, as the MHRA focused considerable resources within the agency to deliver accelerated improvements to timescales for clinical trial assessments. The MHRA has made significant progress and most delayed applications have now been processed.

From 31 July to 1 September 2023, the MHRA assessed 1,185 applications for initial clinical trials and amendments. This demonstrates the significant effort that the MHRA has made to address backlogs and move back to assessment in statutory timescales. From 1 September 2023 all newly received fully compliant applications are being assessed within statutory timeframes.