FOI release
MHRA ATMP Assessment Capacity, Regulatory Competitiveness, and Institutional Performance
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00163
Received 14 February 2026
Published 23 March 2026
Request
I am writing to request information under the Freedom of Information Act 2000. This request relates to MHRA's institutional capacity, performance, and strategic planning regarding the assessment of Advanced Therapy Medicinal Products and the UK's position as a regulatory jurisdiction. It does not seek information about any specific marketing authorisation application. 1. ATMP assessment capacity and resourcing Please provide: (a) The number of MHRA staff (full-time equivalent) currently assigned to or qualified to assess marketing authorisation applications for Advanced Therapy Medicinal Products. (b) Any internal assessments, reports, or board papers produced since January 2023 regarding MHRA's capacity to assess ATMP applications within statutory timeframes. (c) Any internal assessments or reports identifying ATMP assessment capacity as a risk, constraint, or area requiring additional resourcing. (d) Whether MHRA has recruited or sought to recruit additional ATMP assessment expertise since January 2023, and if so, the number of positions and whether they have been filled. 2. Regulatory competitiveness and industry feedback Please provide: (a) Any internal assessments, board papers, or ministerial correspondence produced since January 2023 regarding the UK's attractiveness as a regulatory jurisdiction for ATMP developers, including any analysis of whether MHRA assessment timelines are competitive with the EMA and FDA. (b) Any correspondence between MHRA and the Department of Health and Social Care regarding ATMP assessment backlogs, delays, or capacity constraints since January 2023. (c) Any feedback, complaints, or representations received from pharmaceutical or biotechnology companies regarding MAA assessment timelines under the national procedure since January 2023. I request this in aggregate or anonymised form if individual company identities are commercially sensitive. (d) Any analysis conducted by MHRA comparing its MAA assessment timelines (including clock-stop periods) with those of the EMA, FDA, or other comparable regulators. 3. MAA backlog and performance reporting Please provide: (a) MHRA's published and internal MAA backlog figures for each quarter from Q1 2023 to present, including the number of applications awaiting assessment, in active assessment, in clock-stop, and awaiting decision. (b) Any internal performance reports or KPI dashboards relating to MAA assessment timelines, including whether statutory targets were met, for 2023, 2024, and 2025. (c) Any correspondence or reports prepared for the MHRA Board, the Commission on Human Medicines, or ministers regarding MAA assessment performance or backlogs since January 2023. 4. Impact of regulatory delays on patient access Please provide: (a) Any internal assessments or reports regarding the impact of MAA assessment delays on patient access to medicines in the UK, particularly for treatments addressing serious or life-threatening conditions with high unmet medical need. (b) Any internal assessments regarding whether MHRA's MAA assessment timelines for oncology or ATMP products are consistent with the Agency's stated commitment under the Innovative Licensing and Access Pathway (ILAP) to accelerate patient access to innovative treatments. (c) Any correspondence with NICE regarding the impact of MAA assessment timelines on NICE's ability to conduct timely technology appraisals for products in the MHRA assessment pipeline. 5. Parliamentary and public accountability Please provide: (a) Any briefing materials prepared by MHRA for parliamentary questions, select committee inquiries, or ministerial briefings regarding MAA assessment timelines or ATMP assessment capacity since January 2023. (b) Any responses prepared by MHRA to Freedom of Information requests regarding MAA assessment timelines or backlogs since January 2023. I request these in anonymised form if applicant identities are subject to exemption.
Response
See attached
Documents
This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.
You can browse our other responses or make a new FOI request.