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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2,188 disclosures

  1. ICDs and related ADRs for dopamine agonists in Parkinson’s disease and pituitary tumours

    See attached

    Published: 10 August 2026

  2. FOI request for Keytruda (PBRER body - Section 16. Signal and Risk Evaluation)

    I’m writing this email to submit a Freedom of Information (FOI) request for the latest “Keytruda PBRER – Section 16. Signal and Risk Evaluation”.

    Published: 10 August 2026

  3. Yellow Card Fatal Outcome Reports in Under-18s Following COVID-19 Vaccination

    I write to make a request under the Freedom of Information Act 2000. Background In December 2025, the United States Food and Drug Administration's (FDA) Office of Biostatistics and Pharmacovigilance completed a structured case-level causality review of 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System following COVID-19 vaccination. That review applied the World Health Organization (WHO)–Uppsala Monitoring Centre (UMC) causality assessment framework to each individual case, drawing on medical records, autopsy reports, pathology findings, and follow-up information. The findings were released into the public domain via a United States Senate disclosure in May 2026, and their authenticity has been confirmed by an HHS official. I am conducting independent research into comparative post-market pharmacovigilance practice across medicines regulators, with particular reference to the MHRA, FDA, and European Medicines Agency. The MHRA's statutory obligation to conduct rigorous benefit-risk assessment of authorised medicinal products, and to disclose the basis and limitations of that assessment, provides the domestic regulatory standard against which the question raised by this request is framed. Duty to Confirm or Deny If the MHRA does not hold any of the information requested below, I ask that you confirm that position in writing, as the absence of an equivalent structured review is itself material to comparative research in this area. Information Requested 1. Whether the MHRA has conducted, or commissioned, any structured case-level causality review of Yellow Card fatal outcome reports in individuals aged under 18 years following COVID-19 vaccination, applying a recognised causality assessment framework (such as the WHO-UMC framework or equivalent). 2. If such a review has been conducted: (a) the date or date range of the review; (b) the total number of Yellow Card fatal outcome reports reviewed; (c) the causality classifications assigned, expressed by category (certain, probable/likely, possible, unlikely, unassessable or equivalent); (d) the vaccine products and, where available, the age range of cases reviewed; and (e) whether the review has been published or is otherwise in the public domain, and if so, where. 3. If no such structured review has been conducted: whether the MHRA has assessed paediatric fatal outcome reports following COVID-19 vaccination by any other systematic methodology, and if so, what that methodology was and what its outputs were. Clarification I am not requesting the underlying individual case records. I am requesting the existence and outputs of any structured aggregate causality review, and the methodology applied. I look forward to your acknowledgement of this request and your response within the statutory 20 working days under the Freedom of Information Act 2000.

    Published: 10 August 2026

  4. Absorption of liothyronine by age and gut motility

    What specific patient cohorts were used to establish the bioequivalence data for PL 2011/0270 (Morningside) and PL 00289/2116 (Teva)

    Published: 10 August 2026

  5. Absorption of liothyronine by age and gut motility

    Please provide the full, unredacted statistical values for the Peak Plasma Concentration (Cmax) and the Time to Peak Concentration (Tmax) achieved during the original bioequivalence cross-over trials for both PL 20117/0270 and PL 00289/2116, including the raw numerical data showing the individual participant variances (ranges) rather than just the averaged mathematical mean.

    Published: 10 August 2026

  6. MHRA Inspectorate findings related to basket trials

    Many thanks for suggesting a refinement of my previous request so that it may fall under the cost limit. Please can I request extracts from the MHRA inspection report that relate specifically to the basket trial of a non-commercial organisation inspected in 2024.

    Published: 10 August 2026

  7. MHRA Yellow Card Contact Us Form Submission

    I was wondering if you are able to provide me with the number of yellow cards have been submitted by our staff using nwas.nhs.uk email addresses please within the last 12 months. For GDPR reasons I do not want their names just numbers. I am looking at how we can has a trust improve our processes and awareness of yellow card reporting.

    Published: 10 August 2026

  8. BBC updated request

    This is a request for an update to the previous FOI response ref: FOI2025/00843 For 2025/26 How many unauthorised medicines were seized by the MHRA and/or UKBF? What were the top 10 types of medicines seized?

    Published: 10 August 2026

  9. Request for copies of all finalised Pharmacovigilance inspection reports

    I would be grateful if you could provide copies of all finalised Pharmacovigilance inspection reports from PV inspections conducted by the MHRA between 01-Jan-2025 to 01-Jun-2026. PDF PV inspection reports can be redacted for company proprietary information i.e. EU QPPV details and finding responses/CAPA plans.

    Published: 10 August 2026

  10. Yellow Card Scheme regarding side-effects of the Adjuvanted Trivalent Influenza

    Could you advise me where I can find details of reports made to the Yellow Card Scheme regarding side-effects of the Adjuvanted Trivalent Influenza Vaccine, commonly known as TIV, and brand name of Fluad, for 2020, please?

    Published: 10 August 2026