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I would like to please request some specific data on Yellow card reports. We are currently looking into the incidence of QT interval prolongation in patients on high dose loperamide (taking more than 4mg QDS) for high output stoma/fistula. I can see the number of Torsades de pointes have been reported on the MHRA iDAPs website but would like to know how many of these are related to high dose loperamide. Please could you provide us with the number of QT interval prolongation yellow card reports that have been associated with taking high dose of loperamide (taking more than 4mg QDS).
Published: 29 January 2026
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What costs have been incurred by the Department during the month of December 2025 on Christmas parties/events for staff across the department.
Published: 29 January 2026
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Published: 29 January 2026
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I would like to make a FOI request for information to be emailed to me regarding the following: - All email and text communications between MHRA employees and Citadel Securities between January 1st, 2022 and December 5, 2025, which are not considered exempt - All email and text communications between MHRA employees and GTS Securities between January 1st, 2022 and December 5, 2025, which are not considered exempt Thank you.
Published: 29 January 2026
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We refer to paragraph 4.4 of MHRA's Blue Guide on Advertising and Promotion of Medicines in the UK which asks companies to inform the MHRA (Advertising Standards and Outreach Unit, Vigilance and Risk Management of Medicines Division) of the appointment of, and any subsequent changes to, their qualified signatories to certify advertising material. For each company listed below, please provide (1) the number of qualified signatories who are registered medical practitioners or pharmacists registered in the UK; and (2) the number of other appropriately qualified persons (AQPs), that have been notified to the MHRA as qualified signatories to certify advertising material: 1. AbbVie Limited 2. Amgen Limited 3. AstraZeneca Plc 4. Bayer Plc 5. Boehringer Ingelheim Limited 6. Bristol-Myers Squibb Pharmaceuticals Limited 7. Eli Lilly and Company Limited 8. Fresenius Medical Care (UK) Limited 9. Gilead Sciences 10. GlaxoSmithKline Plc 11. Johnson & Johnson Innovative Medicine 12. Merck 13. MSD 14. Novartis Pharmaceuticals UK Limited 15. Novo Nordisk Limited 16. Pfizer Limited 17. Roche 18. Sanofi Limited 19. Takeda UK Limited 20. CSL Behring UK Ltd
Published: 29 January 2026
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Under the Freedom of Information Act 2000, we seek the following information regarding medicinal products previously and currently approved in the UK. We seek the below information on a medicinal product previously approved in the UK, Largactil 25/50/100 mg Tablets which were licensed by Aventis Pharma for use in the UK until 2008: · Confirmation of the qualitative composition of these medicinal products, specifically if the product strengths were based on the Chlorpromazine as Hydrochloride salt or the chlorpromazine base. · Additionally please share copies of the Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for Largactil Tablets (25 mg, 50 mg, 100 mg). We are also seeking the below information on the currently approved product CHLORACTIL/Chlorpromazine HCl - 25 mg, 50 mg, 100mg originally approved in 1988 according to the SmPC published by the MHRA: · Whether Largactil and Chloractil were considered interchangeable (therapeutically equivalent) by MHRA or its predecessor agencies prior to the withdrawal of Largactil from the UK market in 2008. · Any guidance, regulatory decisions, or communications issued by MHRA (or its predecessor) on prescribing or substituting these products (Largactil and Chloractil) during the period of 1988 until 2008. · If available, the reason for Largactil’s withdrawal from the UK market. Please provide the requested information in electronic format via email. If any of the requested documents or information is already publicly available, kindly direct us to the relevant source.
Published: 29 January 2026
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I am currently completing my thesis in collaboration with the Copenhagen Trial Unit (CTU). My research focuses on the development history and regulatory outcomes of direct-acting antivirals (DAAs) for chronic hepatitis C. As part of this project, I am examining the factors that have led to the discontinuation of certain DAA candidates during clinical development and comparing them with agents from the same therapeutic class that successfully reached or remained on the market. To support this analysis, I kindly request any available information regarding the discontinuation of the following DAA: MK-3281 I would be grateful for information specifically on: 1. The stage of development at which the compound was discontinued 2. The primary reason(s) for discontinuation (e.g., safety findings, efficacy results, pharmacokinetics, strategic or commercial considerations) 3. The approximate date when development was halted. This information will be used for academic research purposes in my Master thesis. I am happy to provide documentation confirming my student status, or supervisor confirmation upon request. Thank you very much for your time and assistance. Please let me know if there is a preferred contact or department for such requests.
Published: 29 January 2026
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I am writing to submit a request under the Freedom of Information Act 2000 for specific, quantifiable records concerning the implementation and impact of the UK Rare Diseases Action Plan (2025) regarding accelerated regulatory pathways for innovative rare disease therapies. Please provide the following records: Pipeline Progress (ILAP Status): A list of all innovative rare disease products (including gene therapies) that have been granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) since January 1, 2024, including the current status of their Target Development Plan (TDP). Policy Interpretation (New UK-OD Guidance): Copies of the specific pages or sections from the internal 'Technical Guidance for Industry' draft (or latest working version) for the new UK Orphan Drug (UK-OD) pathway that use an ultra-rare disease product (e.g., a gene therapy) as a worked example or case study to illustrate the new pathway's requirements. Governance/Coordination (MoU/SLA & Alternatives): Copies of any formal Memoranda of Understanding (MoU), Service Level Agreements (SLA), or the Terms of Reference (ToR) for the primary Joint Steering Committee or Working Group tasked with coordinating the regulatory, appraisal, and funding aspects of the Rare Diseases Action Plan between the MHRA and NICE/NHS England since January 1, 2025. f any part of this request is deemed too broad, I ask that you clarify the refusal grounds and provide any records that can be separated, particularly focusing on requests 2 and 3.
Published: 29 January 2026
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Under the Freedom of Information Act 2000, I am writing to request information regarding the Department’s central management and monitoring of Equality Impact Assessments (EQIAs). Please provide responses to the following 5 questions for the financial year 2024/25: 1. Central Oversight: Please confirm if the Department holds a centralised register or database of all EQIAs completed across all directorates. If YES, please provide a copy of this list. If NO, please provide the policy document that sets out how the Department monitors EQIA quality and completion rates centrally. 2. Consultation: Of the EQIAs completed in this period, how many included a formal public consultation period of less than 6 weeks? 3. Cost of Challenge: In the last 3 financial years, what was the total amount (£) paid to external legal counsel for advice, defence, or settlement of Judicial Reviews where equality duties were a cited ground for challenge? 4. Sign-Off: Please provide a list of the 5 EQIAs with the highest financial value completed in the last financial year. For each, state the date the drafting was completed and the date it was approved by the Minister/Permanent Secretary. 5. Monitoring: Please provide the formal policy document detailing the process for post-implementation monitoring of EQIAs. Please provide this information in digital format. If the cost limit is exceeded, please prioritise questions 1, 3, and 5.
Published: 29 January 2026
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I am writing to request information under the Freedom of Information Act 2000. Background / Reason for Request I refer to previous communications indicating that guidance on NeuroCytonix (also referred to as "NeuroCytotron") has not been published by the National Institute for Health and Care Excellence (NICE), and that regulatory licensing and oversight of such treatments is under the remit of your agency, the MHRA. Information Requested 1. Any internal MHRA correspondence, assessments, meeting notes, or other documents (emails, briefings, internal discussions) that refer to NeuroCytonix / NeuroCytotron, Cytotron- or Q-radial-related technology, or any clinical submissions, evaluations or enquiries regarding this technology or treatment. 2. Any external correspondence between MHRA and third parties (e.g. manufacturers, clinicians, members of the public, or other government/health bodies) relating to NeuroCytonix / NeuroCytotron. 3. Any documentation or records explaining MHRA's position or decisions regarding licensing, review or clearance (or refusal thereof) of NeuroCytonix / NeuroCytotron. 4. Any records of communications or referrals from MHRA to other bodies (or from other bodies to MHRA) concerning regulation, licensing or oversight of NeuroCytonix / NeuroCytotron. Please provide the information in electronic format if possible. If fulfilling the request in full would exceed cost or resource limits, I would welcome your guidance on how to narrow it to stay within those limits.
Published: 29 January 2026
