FOI release
MHRA MAA Assessment Policies, Clock-Stop Procedures, and ATMP Processing Timelines
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 FOI2026/00162
Received 14 February 2026
Published 23 March 2026
Request
I am writing to request information under the Freedom of Information Act 2000. This request does not seek information about any specific marketing authorisation application. It relates solely to MHRA's general policies, procedures, and aggregate performance data regarding the assessment of marketing authorisation applications. 1. Clock-stop policies and limits Please provide: (a) MHRA's written policies or guidance governing the use of clock-stops during the assessment of marketing authorisation applications under the national procedure, including any policies specific to Advanced Therapy Medicinal Products (ATMPs). (b) Whether MHRA imposes any maximum permissible duration for a single clock-stop period, or any cumulative maximum for total clock-stop time during an MAA assessment. If so, please provide the applicable limits. (c) Whether MHRA has any policy or mechanism for escalating, intervening in, or expediting an MAA assessment where clock-stop periods become prolonged. If so, please provide the relevant policy or procedural document. (d) Whether MHRA has any obligation to notify the public, patients, patient advocacy groups, or healthcare professionals when an MAA assessment for a serious or life-threatening condition exceeds published statutory timeframes due to extended clock-stops. 2. Aggregate MAA processing statistics Please provide: (a) The total number of marketing authorisation applications currently under assessment via the national procedure (not reliance or cooperative procedures), broken down by product category (small molecule, biologic, ATMP, other). (b) The average total assessment time (clock-on time only, excluding clock-stops) for national procedure MAAs completed in 2024 and 2025, broken down by product category. (c) The average total clock-stop time for national procedure MAAs completed in 2024 and 2025, broken down by product category. (d) The number of national procedure MAAs currently in active clock-stop, and of those, how many have been in clock-stop for more than 6 months and more than 12 months. 3. CHM meeting procedures for MAAs Please provide: (a) MHRA's published or internal guidance on the number of CHM meetings typically required before a marketing authorisation decision is reached under the national procedure. (b) Whether there is any published or internal guidance on the expected timeframe between a final CHM meeting and the issuance of a marketing authorisation decision. (c) The number of national procedure MAAs assessed in 2023, 2024, and 2025 that required more than two CHM meetings before a decision was reached. 4. Label expansion during active MAA assessment Please provide: (a) MHRA's policy or procedural guidance on whether an applicant may seek to expand or modify the proposed indication of a product during an active MAA assessment, as distinct from a post-authorisation variation. (b) If such a procedure exists, whether it has been used for any national procedure MAA in the last three years, and the number of instances. (c) If no such procedure exists, confirmation that no formal pathway exists for mid-assessment label expansion. 5. External control trial (ECT) guidance Please provide: (a) The current status of MHRA's guidance on the acceptability of external control arms and real-world evidence in marketing authorisation applications, including any expected publication date. (b) Any draft or consultation versions of this guidance that have been circulated to stakeholders. If any part of this request exceeds cost or scope limits under Section 12, I would appreciate advice on how the request may be refined to remain within statutory limits.
Response
See attached
Documents
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