FOI release
Refined FOI Request – Aumseqa (Almonertinib) Assessment Documents and PAR Publication Records
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 FOI2026/00806
Received 22 July 2026
Published 9 September 2026
Request
Many thanks for your response, dated 1 July, to my FOI request. I note that you have identified some information falling within my request, but are not able to comply with the request because to do so would exceed the appropriate limit of costs set out in the FOI Act. I make the following additional points and requests in response to your letter. Any documents provided to, generated by or held by MHRA in relation to the assessment of Aumseqa that refer to AstraZeneca and/or Tagrisso (osimertinib) You have said that “Initial searches (including words such as “AstraZeneca” and “Osimertinib, Aumseqa”) have revealed that over 10,000 documents are likely to respond to initial searches”. I appreciate that this is a large number of documents that refer to AstraZeneca during the assessment of Aumseqa. Having reviewed the details in your letter, I set out the following parameters for the request: • Time period: date of application (3 June 2022) to date of authorisation (3 June 2025) of Aumseqa • Search terms: I propose the following search terms, to be combined - “osimertinib” AND (“aumolertinib” OR "almonertinib" OR "HS*10296" OR “EQ143” OR “Aumseqa”) (i.e. documents that include both osimertinib and one of the other terms within the same document) • Example documents: Given these parameters, I would expect at least the following documents to be included in the results, and suggest these documents are first considered by the MHRA: o Lists of Questions or List of Outstanding Issues from the MHRA to the applicant during the assessment of aumolertinib and the Responses to Questions from the applicant o Documents explaining the assessment by MHRA that aumolertinib is a new active substance, as noted in section IV.1 of the PAR. o Any request for scientific advice by the applicant in relation to the development and authorisation of Aumseqa, and the MHRA’s response to any such requests, such as the advice sought on 1 September 2022. Any requests, decisions or correspondence in relation to the timing of, or delay to, the publication of the Aumseqa public assessment report I appreciate the information you have set out about the preparation of the PAR. Having reviewed the details in your letter, I request the following documents: • Initial / first draft PAR provided to MAH as sent on 1 July 2025 • Correspondence with MAH that the assessment reports were particularly lengthy, and the review cycle is expected to be quite involved, provide shortly after 1 July 2025 • Further guidance provided to MAH on 15 July 2025 • MAH’s proposals received 22 July 2025 • Updated PAR draft received from MAH on 22 August 2025 • Updated PAR draft provided to MAH 19 Nov 2025 • Further comments on PAR received 12 December 2025 • Any documents showing input from statistics in Jan 2026 If, despite these restrictions and parameters, this request is still over the appropriate limit, we are happy to pay reasonable costs associated with this search.
Response
See attached
Documents
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