FOI release

MHRA Policies and ATMP Performance Documents

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00304

Received 17 March 2026

Published 8 May 2026

Request

I am therefore formally refining my request in accordance with your Section 16 advice. I am entirely withdrawing all requests for manual data extraction, aggregate statistics, and correspondence searches. This refined request seeks strictly pre-existing, finalised policy documents, standard operating procedures, and the single most recent executive performance reports. Locating a current policy document or a recent Board or Executive Committee KPI dashboard does not require opening individual MAA case folders and cannot reasonably exceed the 24-hour cost limit. Please provide the following existing documents: PART I: Assessment Policies (Refined from FOI2026/00162) 1) Clock-Stop Policies: MHRA's current written policies, Standard Operating Procedures (SOPs), or internal guidance governing the use of, and maximum permissible duration for, clock-stops during the assessment of marketing authorisation applications under the national procedure. 2) Prolonged Clock-Stops: Any written policy or procedural document outlining the mechanism for escalating, intervening in, or expediting an MAA assessment where clock-stop periods become prolonged. 3) CHM Meeting Guidance: MHRA's published or internal guidance regarding the typical number of CHM meetings required before a decision is reached, and the expected timeframe between a final CHM meeting and the issuance of a decision. 4) Label Expansion Policy: MHRA's current policy or procedural guidance detailing whether an applicant may seek to expand or modify the proposed indication of a product during an active MAA assessment. 5) ECT Guidance: The current draft or finalised version of MHRA's guidance on the acceptability of external control arms and real-world evidence in marketing authorisation applications. PART II: ATMP Capacity & Performance (Refined from FOI2026/00163) 1) ATMP Resourcing: The most recent internal organogram, staffing roster, or official headcount report showing the current number of Full-Time Equivalents (FTEs) specifically qualified for or allocated to the assessment of Advanced Therapy Medicinal Products (ATMPs). 2) Current Performance Dashboard: The single most recent monthly or quarterly KPI dashboard, performance report, or equivalent summary document presented to the MHRA Board or Executive Committee detailing current MAA assessment timelines and backlogs. 3) ATMP Capacity Assessment: The most recent Board or Executive Committee paper or formal internal report produced since January 2025 specifically addressing MHRA's capacity to assess ATMP applications within statutory timeframes. If MHRA attempts to apply Section 12 to this narrowed request for specific, pre-existing corporate documents, I will immediately escalate the matter to the Information Commissioner's Office as a failure to comply with Section 1.

Response

See attached

Documents

• COMMISSION ON HUMAN MEDICINES GUIDANCE NOTE FOR APPLICANTS REPRESENTATIONS 2026 v1.0.pdf (301.1 KB)
• FOI2026_00304 (redacted).pdf (2.3 MB)

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