FOI release
MAA assessment status, CHM involvement, and GMP inspection reliance
This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2025/01312
Received 16 December 2025
Published 2 February 2026
Request
I am writing to request information under the Freedom of Information Act 2000 relating to the Marketing Authorisation Application (MAA) submitted by Northwest Biotherapeutics, Inc for DCVax-L, an immunotherapy for glioblastoma, which was submitted to the MHRA in December 2023. Specifically, I request the following information: 1. CHM meeting materials Please provide: The agenda, minutes, and any published or unpublished recommendations arising from the Commission on Human Medicines (CHM) meeting held around June 2024 that considered the DCVax-L application. • Any formal advice, conclusions, or recommendations issued by CHM to MHRA in relation to this application. • Any action items or follow-up requests communicated to Northwest Biotherapeutics following that CHM meeting. • If any information is withheld under an exemption, please identify the relevant exemption(s) and provide the remainder of the information where possible. 2. GMP inspection status - Advent Bioservices (Sawston) Please provide: • The date(s) on which MHRA conducted GMP inspections of Advent Bioservices Ltd, Sawston, that were relied upon or referenced in the assessment of the DCVax-L MAA. • Confirmation of whether those inspections have been completed. • Confirmation of whether the outcome of those inspections was considered satisfactory for the purposes of the DCVax-L MAA assessment. 3. Regulatory status and decision timeline Please provide: • The current assessment status of the DCVax-L Marketing Authorisation Application (eg, under active assessment, clock-stop, final review, or decision-making phase). • Confirmation of whether the MHRA has completed all scientific, clinical, and GMP assessments required to reach a decision. • If available, the expected timeframe for issuance of a regulatory decision on the application. 4. Reliance on manufacturing authorisations Please confirm: • Whether the Human Medicines Manufacturer’s Authorisation (MIA) held by Advent Bioservices Ltd is currently being relied upon for the DCVax-L MAA. • Whether any updates or re-issuance of that MIA were conducted in connection with the DCVax-L assessment. • If any part of this request exceeds cost or scope limits under Section 12 of the Act, I would appreciate advice on how the request may be refined to remain within statutory limits.
Response
See attached
Documents
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