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I want to get access to the Clinical Study Report with the identifier STL-N/S-95-003 which was done by the sponsor Pfizer on the active ingredient Sertraline (Brand name: Zoloft).
Published: 5 June 2026
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This request follows your Internal Review decision IR2026/00280 dated 30 March 2026, in which the Agency placed the following on record: 'All MHRA documents were included in the search, across departments and teams, including expert committees'; 'All documents the Agency holds were included in the search, including all documents submitted by stakeholders to the MHRA'; 'The search scope was not limited to documents explicitly labelled as oncology-related assessments.' This request tests and narrows that scope statement rather than expanding it. DHSC has confirmed (FOI-1672956, acknowledged in FOI-1680035) that searches of departmental systems using oncology-related terms returned over 1,600 items. MHRA's position in FOI2026/00153, FOI2026/00239 and IR2026/00280 is that no formal oncology risk assessment was conducted, commissioned or received. The request below probes a specific, narrow subset of MHRA holdings that falls inside the IR2026/00280 scope statement. Request 1. Please provide the minutes, agendas, or formal action records of: (a) the Commission on Human Medicines (CHM); and (b) the CHM Vaccines Expert Working Group (VEWG), covering the period 1 January 2020 to 31 December 2023, where the minuted discussion references any of: p53, DNA-damage response, tumour suppressor, genotoxicity, spike protein pharmacology, immune surveillance, or BRCA1/BRCA2. 2. Please identify the named MHRA officer or role accountable for the search undertaken in response to FOI2026/00153 and upheld in IR2026/00280, and the named officer accountable for the comprehensive-search statement quoted above. 3. Please confirm that 'stakeholder submissions' as referenced in IR2026/00280 includes marketing authorisation dossiers, toxicology summaries, and pharmacology submissions from COVID-19 vaccine authorisation holders (Pfizer/BioNTech, Moderna, Oxford/AstraZeneca, Novavax, Valneva, Janssen). 4. In the event that no such CHM or VEWG minutes exist for the period specified, please confirm explicitly in those terms, given that such a confirmation will establish the outer boundary of the IR2026/00280 scope statement. Scope and cost This request is deliberately narrow: two named committees, a four-year window, a specific list of scientific terms, and a binary question on the boundary of an already-disclosed scope statement. It is not a campaign request and is not aggregable with unrelated correspondence under Section 12(4). The request tests the integrity of a statement the Agency has itself placed on the public record.
Published: 5 June 2026
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For the years from April 2021 to present, the last 5 years, 1/ how many suspected unexpected serious adverse reactions have there been in human participants in clinical trials in the UK and 2/ how many people have died?
Published: 5 June 2026
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My request relates to Pfizer's 'Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine' (ref C4591021). Interim Report 5 reported significantly higher incidence of some serious heart-related conditions among the vaccinated cohort. 1. In relation to Interim Report 5: a) when did MHRA decide to remove the Section 22 Exemption? b) when, by whom and where was Interim Report 5 published? c) please can I have a copy of MHRA's assessment of it 2. In relation to the Final Report: a) does MHRA hold a copy of the Final Report? b) if so, when did MHRA receive it? c) please can you send me a copy d) please can I have a copy of MHRA's assessment of it
Published: 5 June 2026
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Published: 5 June 2026
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Under the Freedom of Information Act 2000, I request a copy of the following inspection report: Knox Pharmaceuticals Ltd Type of inspection, GDP Approximate inspection date, Feb 2021
Published: 5 June 2026
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Please provide a copy of the "User Reference Guide: Individual Case Safety Reports (ICSRs) Submissions" as described in https://mhrainspectorate.blog.gov.uk/2022/08/03/decommission-of-esusar/ Please provide the information in email or similar format If it is not possible to provide the information requested due to the information exceeding the cost of compliance limits identified in Section 12, please provide advice and assistance, under the Section 16 obligations of the Act, as to how I can refine my request. If you can identify any ways that my request could be refined I would be grateful for any further advice and assistance. If you have any queries please don’t hesitate to contact me via email and I will be very happy to clarify what I am asking for and discuss the request.
Published: 5 June 2026
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This is an information request relating to private health insurance for staff. Please provide me with the following information for the 2025-26 financial year: 1. The total amount spent by your organisation on funding or subsidising private healthcare/medical insurance for your staff during the 2025-26 financial year. 1. A summary or copy of the private healthcare policy/policies currently available to your staff. Please include details regarding the level of cover provided and the eligibility criteria for staff to access this benefit (e.g., whether it is available to all staff, or restricted to certain pay grades or roles). 1. The total number of staff members who were enrolled in or successfully claimed from this private healthcare scheme during the 2025-26 financial year. If it is not possible to provide the information requested due to the information exceeding the cost of compliance limits identified in Section 12, please provide advice and assistance, under the Section 16 obligations of the Act, as to how I can refine my request.
Published: 5 June 2026
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Dear MHRA FOI Team, Thank you for your response of 6 May 2026, stating that the MHRA does not hold information regarding the scientific evidence review or rationale that justifies Levothyroxine monotherapy as the UK’s 'first choice' or the standard treatment. I find this admission concerning from a statutory perspective. Under the Human Medicines Regulations, the MHRA is the designated body responsible for the safety, quality, and efficacy of medicines in the UK. If the MHRA does not hold the scientific rationale for the efficacy of the UK’s third most-prescribed drug, I request a formal clarification on the following: 1. Statutory: How does the MHRA fulfill its duty to ensure the ongoing efficacy of Levothyroxine monotherapy if it holds no internal scientific review of the biological mechanisms (specifically deiodination/conversion) that justify its licence? 2. Regulatory: In a concurrent response (Ref: CEO 20584), the MHRA CEO’s office states that the product’s efficacy is predicated on conversion to the active ligand. If the FOI team holds no records of this rationale, does this indicate that the MHRA is relying entirely on third-party guidelines (e.g., NICE, BTA, and SfE)—none of which account for the mechanisms of deiodinases or conversion—rather than conducting its own independent regulatory due diligence? 3. Information Not Held: If the MHRA enforces manufacturing standards for this drug but does not hold the scientific rationale for its biological 'Action and Use,' at what point did the MHRA decouple manufacturing oversight from biological efficacy? I wish to register this as a formal challenge to the adequacy of the search. It is implausible that a statutory regulator holds no record of the scientific basis for the primary treatment of a condition affecting millions.
Published: 5 June 2026
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1. Further to FOI 2025/00636, please provide the following information per year for Isle of Man postcode yellowcard reports for Covid vaccines covering from 01 January 2021 to current date: A. Total number of reports where the primary reporter qualification was Healthcare Professional (HCP). B. Of those HCP reports, how many were classified as "serious" under MHRA seriousness criteria. C. Of those HCP reports, how many recorded a fatal outcome. (If small numbers require suppression, please provide totals across all years combined rather than yearly breakdown.) 2. A.Please confirm whether previous Isle of Man totals provided in response to FOI 2025/00636 include reports submitted by Marketing Authorisation Holders (industry). B. If not, please provide the total number of industry-submitted COVID-19 vaccine reports associated with Isle of Man postcode as one figure. 3. A.Please confirm whether any Isle of Man COVID-19 vaccine recipients were included in the MHRA's enhanced or active monitoring programmes (including the Yellow Card follow-up surveys or similar schemes). B. If so, how many were contacted since 2021?
Published: 5 June 2026
