Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

If you can't find the information you're looking for, you can make a new FOI request.

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2,004 disclosures

  1. can you please send me the Clinical Study Report of the study with the identifier STL-CDN-94-00-002? This study should have been done by Pfizer using the medication Zoloft.

    Published: 12 May 2026

  2. I am writing to request information under the Freedom of Information Act 2000. Please provide a copy of the MHRA letter dated 7 November 2025 that is referenced in correspondence with the sponsor of the PATHWAYS clinical trial (relating to puberty blockers / GnRH analogues in children and young people). If the full letter cannot be disclosed, I request that you provide: 1. The full text with any personal data appropriately redacted; or 2. If any exemptions are applied, a copy of the letter with exempted material redacted, together with a clear explanation of which exemptions have been relied upon and why; and 3. Any covering note or summary document produced by MHRA that describes the content, purpose, or regulatory concerns raised in the letter. I am seeking this information in the public interest, as the PATHWAYS trial is a matter of significant public, clinical, and ethical interest. Please provide the information electronically by email. If my request is too broad or would exceed the cost limit, I would be grateful if you could advise how it might be refined so that some or all of the information can be disclosed.

    Published: 12 May 2026

  3. Under the Freedom of Information Act 2000, please provide the following recorded information. From the last 3 financial year's budgeted figures (2022/23, 23/24, 24/25): 1. Climate-related posts a) The number of posts if any (headcount, and FTE where recorded) employed with job titles that include any of the following terms: Climate; Net Zero; Sustainability; Carbon; Emissions; Environmental Sustainability; Climate Change; Climate Action; Climate Policy; Climate Programme; Climate Project; Climate Data; Climate Reporting; Climate Adaptation; Climate Resilience; Energy and Climate; Sustainable Procurement; Green Finance; Green. 2. Cost of those posts The total employment cost for the posts (if any) identified in Question 1, including salary and employer on-costs (e.g. pension and National Insurance), as recorded. 3. External consultants The total amount paid during the same financial year to external consultants, companies, or contractors where the expenditure is recorded under any cost centre, project code, budget line, or purchase description that includes one or more of the following terms: Climate; Net Zero; Sustainability; Carbon; Emissions; Environmental Sustainability; Climate Change; Climate Action; Climate Policy; Climate Programme; Climate Project; Climate Data; Climate Reporting; Climate Adaptation; Climate Resilience; Energy and Climate; Sustainable Procurement; Green Finance; Green. This should include, but not be limited to, expenditure coded to professional services, consultancy, advisory services, or specialist support. If you do not record expenditure in this way, please provide the closest equivalent recorded information held (for example, totals by relevant cost centre or project). If any information requested is not held, please state this clearly. If figures are held only in aggregated form, please provide the aggregated figures. Estimates derived from recorded financial information are acceptable. If complying with this request would exceed the cost limit under Section 12 of the Freedom of Information Act, please disregard point 3. Please provide the information requested above in the following table format, where held: Financial Year Job Title Staff Costs including on-costs (£) Headcount Consultant Spend

    Published: 12 May 2026

  4. Please provide any internal scientific assessment reports, assessor summaries, or committee briefing documents held by MHRA relating to the assessment and approval of Difflam 0.15% w/v Spray, authorised 30 November 1984 in relation to: - Variation to add the age ranges '2 to 6 years' and '6 to 12 years' to the posology. - Changes to the legal classification of this product since MA grant. If full disclosure is not possible, please provide confirmation of the existence of such documents and the exemptions relied upon.

    Published: 12 May 2026

  5. I would like to submit freedom of information request in relation to 'Difflam 0.15% w/v Spray'. I would like to know the date of approval when the age ranges '2 to 6 years' and '6 to 12 years' were added to the original license. I would like a copy of the assessment report for this variation. I would like a copy of the clinical overview for this application. I would like to if the legal classification (pharmacy only) has changed (or not) since the original MA grant on 30 November 1984, dates of approval, and any assessment reports / public consultations that were carried out as part of any changes to the legal classification.

    Published: 12 May 2026

  6. Under FOIA, please can you tell me the following: The annual numbers of reports of impulsive behaviour side effects of dopamine agonist drugs for each of the years the MHRA holds data for. Please break down per a) type of impulsive behaviour (e.g. hypersexuality, gambling, shopping, eating) and b) provenance of report (e.g. clinician, patient or relative, manufacturer).

    Published: 12 May 2026

  7. Under the Freedom of Information Act 2000, I would like to request copies of all internal correspondence (including emails, instant messages, notes, memos, and minutes of meetings) held by Medicines & Healthcare products Regulatory Agency, regarding the processing of my previous request FOI2026/00232 submitted on 1 March 2026, regarding meetings and correspondence between the MHRA and the organisations Sex Matter and the LGB Alliance. Specifically, I am interested in: * Emails and correspondence discussing the interpretation or scope of the request. * Internal debates regarding the application of exemptions (e.g., Section 36, Section 40, etc.). * Drafts of the final response and any related internal briefing notes. I understand that this request is for recorded information and I would prefer to receive this in electronic format. If this request is too broad, I would be grateful for your advice and assistance under section 16 of the Act to refine it.

    Published: 12 May 2026

  8. I would like to request the following information under the Freedom of Information Act. 1.Please could you tell me how much was spent by staff in your organisation on the Government Procurement Card, or any other credit card paid using public funds, in each of the following years: a) 2026 to date b) 2025 c) 2024 d) 2023 2.For each year in question 1, please provide a full breakdown of the items purchased and if possible, please state the item, the amount spent, the date and any details you hold on the reason the item was purchased. 3.Please state how many of these Government Procurement cards (or other cards paid using public funds) were in use in your organisation in each of the following years: a) 2026 to date b) 2025 c) 2024 d) 2023

    Published: 12 May 2026

  9. Please could you tell me the total number of adverse drug reactions (ADRs) reported to you through the Yellow Card scheme in the 2025 calendar year? In relation to the figures for 2025 could you also provide (i) the number of UK suspected ADR reports received with a fatal outcome, (ii) number of ADR reports received which resulted in prolonged hospitalisation and (iii) the number of reports received which resulted in prolonged hospitalisation AND had a fatal outcome? In relation to the fatal outcomes could you please provide a table showing the ten drugs that were most frequently recorded as having caused such a reaction along with the number of times each one was recorded as having a fatal outcome.

    Published: 12 May 2026

  10. Under the provisions of the Freedom of Information Act 2000, I am requesting the following information regarding the regulatory status, supply restrictions, and review process for subcutaneous hormone implants (specifically 25mg and 50mg Oestradiol and Testosterone pellets). 1. Regulatory Status and Patient Access - Please provide the current official MHRA policy regarding the initiation of new patients on oestrogen implant therapy. - Does the MHRA hold any recorded documentation or clinical guidance that mandates a "zero-initiation" policy for new patients in cases where all licensed alternatives have failed? - Please provide the recorded criteria or conditions that must be met for the "existing patients only" restriction to be formally rescinded. 2. Alternative Manufacturers and cGMP Assessments - Is the MHRA currently engaged in an active regulatory review of alternative manufacturers (e.g., manufacturers based in Australia or Europe) for the supply of oestradiol or testosterone implants to the UK market? - Please provide the number of applications or "Special" clinical need requests received or reviewed by the MHRA for imported hormone implants from non-APT facilities between February 2025 and March 2026. 3. Review Status (APT Facility) - Please confirm if the regulatory review regarding implants manufactured at the APT facility is officially concluded. - If the review is ongoing, please provide the most recent recorded "estimated completion date" for this assessment. 4. Continuity of Supply (Stock Levels) - Following the February 2025 update regarding an estimated 18-month supply of existing stock, does the MHRA hold a more recent stock audit or supply forecast for oestrogen implants as of March 2026? - Has a new licensed source or Marketing Authorisation (MA) holder been identified or approved for these products since February 2025? 5. Testosterone Implants - Please provide the current regulatory status of testosterone subcutaneous implants. - Is this specific product subject to the same "existing patients only" supply restriction as oestrogen implants?

    Published: 12 May 2026