PARLIAMENTARY WRITTEN QUESTION
Medicines and Healthcare products Regulatory Agency: Clinical Trials (1 February 2024)

To ask the Secretary of State for Health and Social Care, what assessment she has made of the potential obstacles to the Medicines and Healthcare products Regulatory Agency meeting its statutory licensing commitments for clinical trials for the year 2022-23.

Asked by:
Karin Smyth (Labour)

The Medicines and Healthcare products Regulatory Agency (MHRA) has been transparent about its performance, and since March 2023 has published monthly data indicating the number of clinical trial applications and average timescales for applications to be assessed. All regulatory assessments for clinical trials have been completed within the statutory timescales of 30 days since September 2023.

This stabilised and improved performance reflects the significant effort MHRA made to eliminate all backlogs. Over 2,400 clinical trial applications, including amendments and initials, were assessed from mid-July 2023 to the end of September 2023.

The MHRA has now embedded improvements into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the United Kingdom remains a prime destination for clinical trials.

Answered by:
Andrew Stephenson (Conservative)
6 February 2024