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.

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2,269 disclosures

  1. I am writing to request information under the Freedom of Information Act (2000). I understand that the MHRA has said that doctors should report all suspected inaccuracies caused by AI tools used in clinical practice to the regulator’s yellow card scheme. I would like to know: 1. To date, how many times the MHRA has been made aware of inaccuracies or concerns caused by AI tools used in clinical practice. 2. How many of these (issues flagged) were related to AI-enabled ambient scribing products 3. Please give the details of each issue flagged - including the name of the product used, the details of who contacted the MHRA (e.g. GP surgery name or Trust) and details of what the concern was. 4. Is the MHRA sent hazard reports related to AI-enabled ambient scribing products, collated by medical practices? If so, please supply all the hazard reports which have been received since April 2025. If you are unable to answer any part of this request please move on to the next question and provide as much information as you can. I would like to receive this information in the form of an email reply. If this request is too wide or unclear, I would be grateful if you could contact me as I understand that under the Act you are required to advise and assist requesters. If any of this information is already in the public domain, please can you direct me to it, with page references and URLs if necessary. I understand that you are required to respond to my request within the 20 working days after you receive this letter. I would be grateful if you could confirm in writing that you have received this request.

    Published: 8 September 2026

  2. Please can you provide a copy of the current, approved Risk Management Plan for the following product: Product details: Neulasta 6 mg solution for injection Active substance: pegfilgrastim MA Number: PLGB 13832/0033 MAH: Amgen Ltd

    Published: 7 September 2026

  3. Under the Freedom of Information Act 2000, I request a copy of the Borderline Advice response issued under reference 2026-000124.

    Published: 7 September 2026

  4. Many thanks for your response and for confirming the status of my request. I am grateful for your compromise for me to limit my request to five (5) PV inspection reports. After reviewing the line listing you provided, I would like to receive the following inspection reports: 1. Pfizer 2. MSD 3. Bayer 4. Organon 5. Advanz Pharma

    Published: 7 September 2026

  5. Dear Sirs I am writing to request the clinical and non clinical overviews for PL PL 49578/0040 - Sucralfate 1 g/5 ml Oral Suspension by Roma Pharmaceuticals. Many thanks

    Published: 7 September 2026

  6. To reduce the burden of the request, I would like to amend it and proceed without the request for any follow-up correspondence relating to inspection outcomes. Please provide the inspection reports and any associated deficiency reports, CAPAs, or compliance letters only. Please let me know if any further refinement is required.

    Published: 7 September 2026

  7. I am writing a Freedom of Information request in order to request authorisation details for the Differin 0.1% w/w Gel (PL 10590/0015). * Please can you confirm the legal basis and route of authorisation? * Please can you confirm the licencing history? * Please can you provide any available public assessment reports?

    Published: 7 September 2026

  8. Information request for Public assessment reports, non-clinical/clinical expert reports and/or lists of references for the following three well established products - MAH = Alturix Phosphate Sandoz (PL 44490/0002) Sando-K (PL44490/003) Slow Sodium (PL 44490/004) If you are not able to provide assessment reports or expert reports themselves then just pivotal literature references which formed the well established use basis on which these three products were granted registration. Thank you very much

    Published: 7 September 2026

  9. Can you please share Approved Clinical Overview for below product? Product name: Co-codamol 15 mg/500 mg tablets PL 44521/0001 MAH: Generic Speciality Pharma Limited

    Published: 7 September 2026

  10. See attached

    Published: 7 September 2026