FOI release
National MAA review procedures, RFIs, and DCVax-L
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 FOI2026/01039
Received 14 September 2026
Published 9 October 2026
Request
I am requesting recorded information concerning the assessment of national marketing authorisation applications, particularly innovative/biological medicinal products submitted before 3 April 2025 and remaining under assessment after that date. I am not requesting the contents of any applicant’s regulatory dossier, RFI questions or responses, confidential clinical/manufacturing information, assessor opinions, or commercially confidential information. Where a question below is phrased as a question, please treat it as a request for any recorded guidance, policy, SOP, work instruction, data, correspondence template, or other information held by MHRA that answers it. 1. Procedure applicable to legacy applications Please provide any recorded guidance, SOP, transitional instruction or policy explaining which assessment procedure applies to a national MAA that: was submitted and validated before 3 April 2025; and remained under active MHRA assessment after 3 April 2025. In particular, did such applications remain under the former 150-day national assessment procedure, transition to the National Assessment Procedure published on 3 April 2025, or follow another transitional procedure? 2. Meaning of second and subsequent RFIs under the procedure applicable to those legacy applications Please provide any recorded information explaining: a. the circumstances in which a second RFI would be issued; b. whether a second RFI could contain unresolved major objections which, if unresolved, would preclude marketing authorisation, or whether second RFIs were ordinarily/reserved for minor or otherwise resolvable outstanding matters; c. the circumstances in which a third or subsequent RFI could be issued; d. whether there was any maximum or usual number of RFIs; e. when unresolved issues would instead result in consultation with the Commission on Human Medicines and/or a CHM letter concerning possible non-approvability; and f. whether satisfactory resolution of a second/subsequent RFI would ordinarily be followed by final compliance checks before grant. 3. Historical outcome data by number of RFIs For completed national MAAs for innovative medicines, new active substances, biological products, ATMPs or vaccines assessed under the former national/150-day procedure, preferably covering 1 January 2021 through 2 April 2025, please provide, if held in readily retrievable form: number receiving zero RFIs and final outcome: grant / refusal / withdrawal; number receiving one RFI and final outcome: grant / refusal / withdrawal; number receiving two RFIs and final outcome: grant / refusal / withdrawal; number receiving three or more RFIs and final outcome: grant / refusal / withdrawal. If MHRA does not hold this exact table but holds an existing dataset from which these fields can readily be extracted, please provide that dataset or the closest existing aggregate information rather than creating new analysis. 4. Historical outcome data for unusually prolonged reviews For the same class of completed applications, if readily held, please provide counts by final outcome (grant / refusal / withdrawal) for applications whose elapsed time from validation/procedure start to final disposition exceeded: 12 months; 18 months; 24 months. If MHRA instead records duration in clock-on assessment days, clock-stop periods, or another measure, please provide the closest existing information. I am particularly interested in whether very prolonged reviews historically have materially different grant/refusal/withdrawal outcomes. 5. Historical outcome following CHM concern If readily available, for the same period please provide the number of national innovative/biological MAAs that received a CHM letter indicating a provisional view that authorisation might not be granted, broken down by eventual outcome: subsequently granted; refused; withdrawn. 6. Meaning of MHRA terminology Please provide any recorded definition or guidance concerning the phrases: “initial regulatory review” “first regulatory decision” when used in relation to a pending MAA. In particular, does “first regulatory decision” ordinarily refer to the ultimate initial decision to grant or refuse an application, rather than an RFI, clock stop, CHM consultation, provisional CHM opinion, or other intermediate review step? 7. Limited procedural metadata concerning DCVax-L / murcidencel Finally, insofar as the following can be disclosed without revealing confidential scientific or commercial information, please provide the following limited procedural metadata concerning the publicly acknowledged DCVax-L (murcidencel) MAA submitted by Northwest Biotherapeutics in December 2023: a. Which procedural framework currently governs this application: the former 150-day procedure, the post-April-2025 National Assessment Procedure, or another/transitional procedure? b. How many RFIs have been issued to date? c. The month and year only in which each RFI was issued. d. The month and year only in which MHRA received a complete response to each RFI. e. Whether any CHM letter communicating a provisional view that the application might not be approvable has been issued. f. Whether MHRA has notified the applicant that the application has entered final compliance checks. I expressly do not request the substance of any RFI, applicant response, assessment report, CHM deliberation, clinical or CMC issue, regulatory recommendation, or other confidential dossier material. If any portion of question 7 is considered exempt under sections 41, 43 or another provision of FOIA, please disclose any separable non-exempt procedural metadata and identify the exemption relied upon for each withheld item rather than withholding question 7 in its entirety. Similarly, if fulfilling all of questions 3–5 would exceed the Section 12 cost limit, please prioritize the request in the following order: (1) Question 1 (2) Question 2 (3) Question 3 (4) Question 7 (5) Question 5 (6) Question 4 (7) Question 6 If any requested statistical breakdown is not held in exactly the form requested, I would be grateful for the closest existing aggregate data, management information or underlying readily extractable data rather than requiring MHRA to create new information. Please also provide advice and assistance under Section 16 of FOIA if narrowing any element would permit disclosure that otherwise could not be provided.
Response
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