To ask the Secretary of State for Health and Social Care, how many and what proportion of clinical trials were assessed after the statutory timeframe of 30 days in the 2022-23 financial year.
Answered on
6 February 2024
In 2022/23, 693 initial clinical trial authorisation applications were assessed. Out of these, 461 or 66.52% were assessed after the 30-day statutory timeframe.
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 the 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.