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Ifosfamide 40mg/ml Solution for Infusion - PL 00116/0421 Please share risk management plan for above application
Published: 9 March 2026
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I would like to request information on the following: 1) Any internal correspondence relating to the proposed puberty blockers trial 2) The names of the members of the panel who made the decision to write a letter on behalf of the MHRA expressing concern about the proposed puberty blockers trial
Published: 9 March 2026
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Please provide the submission date(s) and UK marketing authorisation (approval) date for all MHRA-authorised gene therapy products approved after Brexit, and please provide the results as an Excel file (or, if not possible, as a CSV table) listing product name, submission date(s), and approval date.
Published: 9 March 2026
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Please give me details of any vaccinations that have been subjected to a double blind, placebo controlled trial. Please give me a list of all vaccinations available in the UK, and specify which are on the childhood schedule. Please give me a list of all vaccine ingredients. Please give me Patient Information Leaflets for all vaccinations. Please tell me if the ingredients in UK vaccines differ from those in the USA, and tell me where each vaccine is manufactured, and by whom.
Published: 9 March 2026
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Please could you provide information under the freedom of information Act. I would like to make a freedom of information request to receive any information you may hold about anyone reporting seizures following a flu vaccine in the last ten years.
Published: 9 March 2026
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We are requesting feedback regarding the UK reference product used for the approved Biosimilar product, GOBIVAZ 100 mg solution for injection in pre-filled pen (PL 56734/0027). On review of the public assessment report, published on the MHRA products website (https://mhraproducts4853.blob.core.windows.net/docs/c7ed9e0c96f5a9f982d3281b0f6194e9c180c077), the reference product cited is Simponi 100 mg solution for injection in pre-filled syringe. It is our understanding that this product was licensed via the centralized procedure, however, post-Brexit this licence was not grandfathered into a UK licence. Following implementation of the Windsor Framework guidance, EU marketing authorisations that were not converted to GB MAs are no longer accepted as reference medicinal products. Based on the Gobivaz PAR, this guidance was applicable at the time of MAA submission/approval. Additionally, there is no reference to bridging work being performed within the PAR. Therefore, we are requesting clarity on the approach used in this case, to use Simponi 100 mg solution for injection in pre-filled syringe, as a UK reference product for a biosimilar MAA in the UK.
Published: 9 March 2026
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Dear Medicines and Healthcare Products Regulatory Agency, today I read the following statement in a broadsheet newspaper: "Dr Alison Cave, the chief safety officer at the MHRA, said: "Patient safety is the MHRA's top priority and we continually monitor the safety and efficacy of all licensed medicines. For the vast majority of patients who are prescribed GLP-1s, they are safe and effective medicines which deliver significant health benefits. The risk of developing these severe side effects is very small". Every page of YCS website contains the sentence: "The existence of an adverse reaction report does not necessarily mean that the medicine or vaccine has caused the reaction." Incidence apart, the statement clearly implies causality. Could please explain how Dr Cave assessed causality of pancreatitis following exposure to GLP-1 pharmaceuticals?
Published: 9 March 2026
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I would like to make an FOI request regarding the Covid vaccine, in particular AstraZeneca. I would like to know how many people in the uk...... 1. Have been damaged by this vaccine and unable to work 1. how many of these people are .....a) classes as disabelled and b) had an existing health condition called Graves' disease (thyroid issues) 1. how many people who were already struggling with Graves' disease then had a massive flare and the Graves' disease was triggered since the vaccine I have found medical evidence around the world which clearly confirm people who had Graves' disease and now disabled since having the Covid vaccine I have looked at the Covid vaccine damage claim and feel it's ridiculous the government will only pay compensation if they (not a doctor) feel the person is at least 60% disabled
Published: 9 March 2026
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Thank you for your response to my previous request (FOI2026/00004). In line with your Section 16 advice, I am submitting a narrowed and specific revised request, designed to fall within the statutory cost limit. This revised request is limited to structured adverse-event data only, and excludes internal correspondence, policy development, or narrative analysis. Scope limitations (important) • Time period: 2015–2025 only • Data source: Yellow Card adverse incident reports only • Device focus: Modular hip taper junctions involving: o a stainless steel femoral stem, and o a titanium modular neck sleeve (including BioBall-type systems) • Failure mode: Mechanical or material degradation at the taper interface only ________________________________________ Requested Information 1. Yellow Card reports – taper interface degradation For the period 2015–2025, please provide the number of Yellow Card reports recorded by the MHRA that reference any of the following at a modular hip taper junction involving stainless steel and/or titanium components: • fretting • corrosion • material fragmentation • particulate debris • taper junction failure A year-by-year total is sufficient. ________________________________________ 2. Revision surgery linkage Of the reports identified above, please confirm how many explicitly recorded that revision surgery was required. (A numerical count only; no case narratives required.) ________________________________________ 3. Systemic or local tissue effects (coded fields only) Please confirm, where recorded in structured fields, how many of the reports in Question 1 were associated with: • adverse local tissue reaction (ALTR / metallosis / pseudotumour), and/or • elevated blood metal ion levels Again, aggregate counts only. ________________________________________ 4. Device material classification Please confirm whether, within Yellow Card reporting categories used by the MHRA: • stainless steel femoral stems and • titanium modular neck sleeves are recorded as distinct material classifications, or whether they are grouped under a broader “metal” category for adverse-event coding purposes. ________________________________________ Exclusions (to confirm) For clarity, this request does not seek: • internal MHRA emails or briefing papers • unpublished safety notices • policy deliberations or expert panel discussions • trend analysis or interpretive commentary ________________________________________ If any part of this revised request still risks exceeding the cost limit, I would be grateful if you could indicate which specific question(s) present difficulty, so I may refine further.
Published: 9 March 2026
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We are aware that Clinical Evaluation Requirements are needed so that ECT devices can achieve certification. To our understanding, these requirements are as follows: * Clinical evidence of effectiveness * Post-market surveillance plans * Adverse incident reporting systems (via MHRA) Based on the above, please provide the evidence that manufacturers are providing to the MHRA to demonstrate effectiveness for the purposes of satisfying Clinical Evaluation Requirements. Please provide this evidence for the MECTA ECT device and the Somatics ECT device, respectively.
Published: 9 March 2026
