Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential impact of staffing levels at the Medicines and Healthcare products Regulatory Agency on (a) the time taken by the agency to conduct clinical studies and (b) patient access to clinical studies in each of the last three years.

The average response time for the Medicines and Healthcare products Regulatory Agency (MHRA) to issue its initial written opinion following assessment of a clinical trial authorisation application in each of the last three years was 22.83 days for the financial year 2020/21; 27.45 days for the financial year 2021/22; and 45.94 days for the financial year 2022/23.

The extended timeline for financial year 2022/23 is the result of increased demand to process applications and respond to queries, in response to which the MHRA is increasing resources and improving processes in this area. Vacancies within the Clinical Trials Unit of the MHRA have been filled, including key leadership posts. The MHRA has also recruited seven new clinical trials assessors over the last 12 months and is currently prioritising their training. Moreover, the MHRA is supplementing new assessor capacity with an additional fixed-term resource of appropriately experienced and qualified specialists to support the training and supervision of new staff. The MHRA does not monitor patient access to clinical trials.