Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many full time equivalent staff worked in the MHRA on the licensing of new medicines, biosimilars and generics in each of the last 5 years.

The Medicines and Healthcare products Regulatory Agency (MHRA) has estimated the number of full-time equivalent (FTE) staff who have worked in the MHRA on the licensing of new medicines, biosimilars, and generics for 2019 to 2022, which are:

- 255 FTE staff in 2019;

- 230 FTE staff in 2020;

- 219 FTE staff in 2021; and

- 178 FTE staff in 2022.

Between 2021 and 2023 the MHRA underwent a significant process of transformation and changes to the structure and function of the operating groups across the agency. Throughout this period, there were a range of professionals across the agency working on the licensing of new medicines, biosimilars, and generics. However, the information required to answer this question in full is not available, as the data is unvalidated.

Staffing levels at the MHRA fell between June 2021 and December 2022 due to the One Agency Transformation Programme, as detailed in the MHRA’s Delivery Plan 2021-2023. During this transformation, the MHRA prioritised filling vacancies with contingent resources until the conclusion of the organisational change element of the transformation. This decision was made in order to minimise impact on Civil Servant roles. Since then, the MHRA has been successfully recruiting into the new structure.