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Published: 17 September 2026
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I formally inquire about the regulatory review status of the Marketing Authorization Application (MAA) for DCVax-L (autologous tumor lysate-loaded dendritic cell vaccination), submitted by Northwest Biotherapeutics in December 2023.
Published: 17 September 2026
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Under the Freedom of Information Act, I would like to request the following information within the 20 days timeframe: The number of complaints you have had on pharmacies breaking advertising laws by advertising medicines for weight loss directly to the public over the past three years (July 2023 to July 2026), giving figures by quarters. Please break down the figures between whether the pharmacies are high street or online, and the medications advertised: • Wegovy (semaglutide) – subcutaneous injection • Wegovy (semaglutide) – tablet • Mounjaro (tirzepatide) – subcutaneous injection I am happy for you to supply the information in a way that is most convenient for you but is also as clear as possible.
Published: 17 September 2026
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I am writing to request information under the Freedom of Information Act 2000. Previously, I requested information via FOI2026/00625, but was told my request was not specific enough and would not fall within the costs limit. I would like to make a revised request relating to CTA 56887/0001/001. * All formal submissions to the MHRA relating to safety and any MHRA response for the clinical trial CTA 56887/0001/001. * Final copies of the clinical trial documents (e.g. protocol, Investigator's Brochure) for the clinical trial CTA 56887/0001/001. I appreciate the cost limit is in place, but if both these aspects exceed the limit, could I please have as much relevant documentation as would be possible within the £600 limit.
Published: 17 September 2026
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I am writing with a general enquiry about MHRA policy and procedure. This is not a request under the Freedom of Information Act and is not case-specific. I would be grateful if you could tell me, or point me to where the following is published: 1. How MHRA assesses an allegation that a person has concealed information or products from, or otherwise deliberately misled, an MHRA inspector. 2. Whether there is a procedure or threshold governing referral of such allegations from the inspectorate to the Criminal Enforcement Unit. 3. The definition of "for cause inspection" applied by the Agency, and the circumstances in which a for-cause inspection is conducted following receipt of intelligence alleging unlicensed activity. 4. The criteria applied in deciding whether alleged breaches of the Human Medicines Regulations 2012 are addressed through compliance measures rather than enforcement action.
Published: 17 September 2026
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Please could you provide a breakdown as below: * By age * By sex * What dose/preparation was the patient taking (Aclasta(tm) or Zometa(tm)) * How long the medication was taken for, and whether it was stopped * Whether the patient had any pre disposing cardiac conditions * What the cardiac side effects were, and whether they were reversible (spontaneously, or on stopping the drug) * Was zoledronic acid considered to be cause of the fatal outcome In addition, with regard to the table of reactions by organ class in the Yellow Card reporting summary, please could you provide the same data but solely for Aclasta(tm) since, not only do those patients treated with Zometa(tm) have cancer, but they are given a more intense dosage regimen. This would then allow me to determine whether I would want to seek further detail for any more of the reactions, as per what I have requested for the cardiac side effects above.
Published: 17 September 2026
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I am making the following request under the Freedom of Information Act 2000 in relation to the Medicines and Healthcare products Regulatory Agency (MHRA). For the last two completed financial years (or, if simpler, the last 24 months), please provide: 1. The total number of Freedom of Information requests received by the MHRA. 2. The total number of those requests that proceeded to an internal review. 3. If held, copies of the final FOIA response letters issued in relation to those requests. 4. If held, copies of the internal review outcome letters relating to those requests. For the avoidance of doubt, I am requesting only the final response letters and internal review outcome letters. I am not requesting the underlying correspondence, internal emails, records considered during the requests, or the information requested by the applicants. Where necessary, personal data and any information exempt from disclosure under the Freedom of Information Act may be redacted. If compliance with parts 3 or 4 would exceed the appropriate cost limit under section 12 of the Act, I would be grateful if you would: - provide the information requested in parts 1 and 2; - comply with your duty to provide advice and assistance under section 16 by advising how the request may be refined; - indicate the approximate number of final response letters and internal review outcome letters held for the requested period; - indicate the maximum number of response letters and/or internal review outcome letters that could reasonably be disclosed within the cost limit; and - advise whether the response letters could be disclosed in chronological batches (for example, by month, quarter, or in batches of 50 or 100 letters), so that I may submit a series of refined requests. If any of the requested information is already publicly available, please direct me to the relevant publication or provide the appropriate links.
Published: 17 September 2026
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I would be grateful if you could provide information regarding the following aspects of the Yellow Card Scheme: 1. Funding for the regional Yellow Card Centres The annual funding or commissioning amount allocated to each of the six regional Yellow Card Centres, preferably for the most recent financial years. I would also appreciate clarification on whether this funding is provided through a grant, service contract or another commissioning arrangement. 2. Number of dedicated Yellow Card assessors at the MHRA The number of full-time equivalent MHRA staff specifically involved in reviewing and managing Yellow Card reports. Where possible, could this be divided by functions such as report validation, clinical assessment, follow-up and signal detection? 3. Number of reports received through each reporting route The annual number of reports submitted through: · the Yellow Card website; · the mobile application; · paper forms; · electronic health record or clinical IT systems; · other routes, such as telephone or email-assisted reporting 4. Number of unique suspected adverse reaction cases The annual number of unique suspected adverse reaction cases remaining after duplicate reports from patients, healthcare professionals and pharmaceutical companies have been identified and combined. A brief explanation of how duplicate reports are identified would also be helpful. 5. Reporting by healthcare professionals The measures used to encourage healthcare professionals to report suspected adverse reactions and to reduce under-reporting. In particular, I would be grateful for clarification on whether reporting is regarded as a legal requirement, a professional obligation or a recommendation, and whether compliance or under-reporting is formally monitored. Where this information is already publicly available, links to the relevant reports or datasets would be greatly appreciated.
Published: 17 September 2026
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Dear FOI Team, Under the Freedom of Information Act 2000, I am requesting a copy of the following information held by the Medicines and Healthcare products Regulatory Agency (MHRA): The report "Regulating Large Language Models in Healthcare: Expert and Multi-Stakeholder Perspectives," authored by the CERSI-AI team and workshop attendees (including Dr Joe Alderman and Professor Alastair Denniston), submitted to MHRA and/or the National Commission into the Regulation of AI in Healthcare. A draft version dated January 2026 (Version 2026-01-15) is known to exist; please provide this version and/or any later or final version, whichever you hold. If any part of this information is withheld under an exemption, please specify which exemption(s) are relied upon, and where the exemption is qualified, provide your public interest balancing reasoning, as required under the Act. MHRA's guidance on the regulatory status of AVT products, published 29 July 2026, represents a regulatory decision that has already been made and published. Any research, findings or analysis that related specifically to that decision are not, in my view, protected by an ongoing-deliberation rationale, since that particular deliberation has concluded. I look forward to your response within the statutory 20 working days.
Published: 17 September 2026
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Dear MHRA, I am reviewing the Summary of Product Characteristics (SmPC) for Alimemazine Tartrate 7.5 mg/5 ml Syrup (PL 17780/0465), for which Zentiva Pharma UK Limited is the Marketing Authorisation Holder. I note that sodium sulphite anhydrous (E221) and sodium metabisulphite (E223) are included under the section “Excipients with known effect”, while L(+) ascorbic acid is listed in the full list of excipients in Section 6.1. Could you please confirm the function/role of the following excipients in this medicinal product: Sodium sulphite anhydrous (E221) Sodium metabisulphite (E223) L(+) ascorbic acid
Published: 15 September 2026
