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I am requesting access to original regulatory documents created, reviewed, or held by the MHRA or its predecessor bodies, including the Committee on Safety of Medicines (CSM), relating to teratogenicity studies conducted or assessed in 1972. Information requested 1. Rat study – sodium valproate vs phenytoin Please provide: • The complete 1972 paper/report produced by the CSM Sub-Committee on Toxicity and Clinical Trials concerning rat studies comparing sodium valproate and phenytoin, beginning at pages 0/1 and continuing in full, including: o All pages without omission o Tables, figures, appendices, and statistical analyses o Marginal notes, annotations, or internal commentary o Any accompanying covering papers, briefing notes, or submissions considered alongside the study 2. Rabbit teratogenicity study Please also provide: • The full rabbit teratogenicity study report referred to in the same regulatory context, including: o Complete methodology and results o Any comparative assessment involving sodium valproate and/or phenytoin o Any internal evaluations, conclusions, or regulatory commentary generated by or for the CSM or its sub-committees ________________________________________ Clarifications to prevent misinterpretation • This request is for primary source documents, not summaries, digests, or retrospective reviews. • The age of the documents (circa 1972) strongly suggests that: o Commercial confidentiality exemptions are unlikely to apply, and o Any remaining personal data concerns can be addressed via proportionate redaction. If redactions are applied, please: • Cite the specific FOIA exemption relied upon for each redaction, and • Provide the public interest test reasoning where applicable. Format and time limits
Published: 8 May 2026
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I am writing to request information regarding what formal commitments, obligations, and enforceable standards pharmaceutical companies are required to make, or are expected to meet, in order to bring an end to teratogenicity associated with medicinal products. For the purposes of this request, teratogenicity refers to preventable congenital, developmental, neurological, and lifelong harms arising from exposure to medicinal products before or during pregnancy, including where risks were known, foreseeable, or subsequently established. I respectfully request clarification on the following: 1. Commitments Required of Pharmaceutical Companies 1.1 What explicit commitments are pharmaceutical companies required to make to the MHRA to prevent, minimise, and ultimately eliminate teratogenic harm associated with their products? 1.2 Are companies required to commit to active prevention, rather than risk management alone, where teratogenic potential is identified? 1.3 What obligations exist to ensure that companies prioritise elimination of harm over commercial continuation of products with known teratogenic risk? 2. Pre-Clinical, Clinical, and Post-Marketing Responsibilities 2.1 What commitments must companies make regarding: • Robust pre-clinical reproductive and developmental toxicity testing • Transparent reporting of teratogenicity findings • Prompt action when safety signals emerge 2.2 Are pharmaceutical companies required to commit to continuous reassessment of teratogenic risk throughout a product’s lifecycle? 3. Transparency and Disclosure Commitments 3.1 What commitments do companies make to full transparency of teratogenicity data, including: • Pre-clinical and clinical study findings • Post-marketing surveillance data • Pregnancy exposure outcomes 3.2 Are companies required to provide plain-language information to patients and the public regarding teratogenic risks and prevention measures? 4. Accountability and Enforcement 4.1 What mechanisms does the MHRA have in place to ensure that commitments to end teratogenicity are: • Enforceable • Audited • Subject to sanction where breached 4.2 Are companies required to demonstrate learning from historical teratogenic harm and to implement measures to prevent recurrence? 5. Documentation Please provide copies or links to any: • Regulatory guidance • Codes of practice • Ethical frameworks • Enforcement policies that define or govern pharmaceutical company commitments to preventing and ending teratogenic harm. Thank you for your attention to this request. I look forward to your response in line with principles of transparency, patient safety, and public protection.
Published: 8 May 2026
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. MHRA’s Commitments to Transparency on Teratogenicity Please provide explicit information on the MHRA’s policies, standards, and current or planned commitments in the following areas: 1.1 Regulatory Communication of Teratogenic Risks • How the MHRA identifies, assesses, and communicates teratogenic risks associated with medicines. • Whether and how risk assessments of potential teratogenic effects (including pre-clinical and clinical evidence) are communicated to healthcare professionals, patients, and the public, including timelines. 1.2 Publication of Safety Information • How and when the MHRA publishes safety signals and assessments related to teratogenicity (e.g., emerging evidence from post-marketing surveillance, safety reviews). • What public registries, safety update reports, or risk communications the MHRA uses to ensure this information is accessible. 1.3 Evidence Summaries and Decision Rationales • Whether MHRA publishes plain-language summaries or detailed rationales explaining how decisions involving teratogenic risk were reached (e.g., product labeling changes, contraindications, pregnancy warnings). • If such summaries exist, the timelines within which they are made available following decision points. 1.4 Patient and Public Engagement • How the MHRA engages with patients, advocacy groups, health professionals, and the public to inform them about the potential teratogenic risks of medicines. • Whether there are mechanisms for patient feedback or involvement in regulatory communications specific to teratogenic risk. • How does the MHRA choose members of any teratogenic stakeholder groups within the MHRA 1.5 Confidentiality vs Public Interest • How the MHRA balances commercial confidentiality with the public interest in disclosing teratogenic risk data. • The criteria used to decide when safety data, trial results, or risk-related evidence is withheld or published. 2. Transparency Obligations Imposed on Pharmaceutical Companies Related to Teratogenicity Please clarify what specific transparency requirements pharmaceutical companies must fulfil when interacting with the MHRA, particularly with respect to teratogenicity evidence, including but not limited to: 2.1 Pre-Clinical and Clinical Study Transparency • Requirements for companies to disclose pre-clinical developmental and reproductive toxicity (DART) studies that assess teratogenic risk. • Obligations to publicly register and report clinical trial results that include teratogenicity endpoints, including timelines and public registries used. 2.2 Labelling, Risk Communication, and Pregnancy Guidance • Mandatory requirements for companies to include teratogenic risk information in product labelling, patient safety leaflets, pregnancy warnings, or healthcare professional materials. • Whether plain-language pregnancy exposure guidance and teratogenic risk summaries must be provided to the MHRA and made publicly available. 2.3 Post-Marketing Surveillance and Safety Reporting • Obligations of Marketing Authorisation Holders (MAHs) to report reports of congenital anomalies or suspected teratogenic outcomes in pharmacovigilance systems (e.g., Yellow Card reporting). • Timelines, formats, and public disclosure expectations for such post-marketing safety reports. 2.4 Anonymised Data Sharing and Accessibility • Whether companies are required to share anonymised individual-level teratogenicity data or study datasets with the MHRA and, if so, whether there is an expectation for such data to be made available to the public or research community. 2.5 Conflict of Interest and Industry Conduct Transparency • Expectations or requirements relating to transparency of industry involvement in research, advisory committee participation, or funding associated with teratogenicity studies. 3. Public Access to Teratogenicity Information 3.1 Public Platforms and Accessibility • Please specify which platform(s) the MHRA uses to make teratogenicity-related regulatory information available (e.g., public registers, databases, safety update pages) and how individuals can access this information at no cost. 3.2 Format and Clarity • Whether the MHRA has commitments to publish information about teratogenic risk in readily understandable formats for patients, researchers, clinicians, and the public (e.g., plain language summaries, structured risk tables). 4. Request for Documents and Policies I respectfully request copies (or links) to the following MHRA documents, policies, and guidance: 1. MHRA’s current policy on transparency of teratogenic risk assessments and communications. 2. Regulatory guidance on teratogenicity data expectations from pharmaceutical companies (pre-clinical, clinical, post-marketing). 3. Policy or guidance documents regarding public disclosure of teratogenicity data and safety signals. 4. Any internal standards or frameworks used by MHRA to evaluate and disclose teratogenic risk information
Published: 8 May 2026
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Under the UK Freedom of Information Act 2000, I am writing to request information held by the MHRA regarding the drug retatrutide. Specifically, I would like to request: 1. Any records of clinical trial approvals for retatrutide in the UK, including trial identifiers and statuses/timeframe of when clinical trials will finish 2. Any regulatory correspondence, safety assessments, or inspection reports related to retatrutide submitted to or reviewed by the MHRA. 3. Any releasable documents on projected timelines for clinical trial completion, regulatory review, or potential marketing authorisation. 4. Any MHRA-held data summarising adverse events, safety signals, or efficacy results submitted as part of UK clinical trials or post-market monitoring if applicable. (UK ONLY) 5. Any email communications held by the MHRA regarding the drug retatrutide between the agency and Eli Lilly or any other parties, including those relating to clinical trial applications, safety assessments, or regulatory approvals. I request that these emails, or non-exempt portions thereof, be released
Published: 8 May 2026
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I am therefore formally refining my request in accordance with your Section 16 advice. I am entirely withdrawing all requests for manual data extraction, aggregate statistics, and correspondence searches. This refined request seeks strictly pre-existing, finalised policy documents, standard operating procedures, and the single most recent executive performance reports. Locating a current policy document or a recent Board or Executive Committee KPI dashboard does not require opening individual MAA case folders and cannot reasonably exceed the 24-hour cost limit. Please provide the following existing documents: PART I: Assessment Policies (Refined from FOI2026/00162) 1) Clock-Stop Policies: MHRA's current written policies, Standard Operating Procedures (SOPs), or internal guidance governing the use of, and maximum permissible duration for, clock-stops during the assessment of marketing authorisation applications under the national procedure. 2) Prolonged Clock-Stops: Any written policy or procedural document outlining the mechanism for escalating, intervening in, or expediting an MAA assessment where clock-stop periods become prolonged. 3) CHM Meeting Guidance: MHRA's published or internal guidance regarding the typical number of CHM meetings required before a decision is reached, and the expected timeframe between a final CHM meeting and the issuance of a decision. 4) Label Expansion Policy: MHRA's current policy or procedural guidance detailing whether an applicant may seek to expand or modify the proposed indication of a product during an active MAA assessment. 5) ECT Guidance: The current draft or finalised version of MHRA's guidance on the acceptability of external control arms and real-world evidence in marketing authorisation applications. PART II: ATMP Capacity & Performance (Refined from FOI2026/00163) 1) ATMP Resourcing: The most recent internal organogram, staffing roster, or official headcount report showing the current number of Full-Time Equivalents (FTEs) specifically qualified for or allocated to the assessment of Advanced Therapy Medicinal Products (ATMPs). 2) Current Performance Dashboard: The single most recent monthly or quarterly KPI dashboard, performance report, or equivalent summary document presented to the MHRA Board or Executive Committee detailing current MAA assessment timelines and backlogs. 3) ATMP Capacity Assessment: The most recent Board or Executive Committee paper or formal internal report produced since January 2025 specifically addressing MHRA's capacity to assess ATMP applications within statutory timeframes. If MHRA attempts to apply Section 12 to this narrowed request for specific, pre-existing corporate documents, I will immediately escalate the matter to the Information Commissioner's Office as a failure to comply with Section 1.
Published: 8 May 2026
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I hope you are well. Once again thank you so much for responding to my email. However, there is an area of concern as despite several attempt for Noble Health to disclose this information has been futile until most recently. Furthermore, the information you provided is inconsistent with their response via their solicitor. Please can you confirm the veracity and accuracy of this statement from their solicitor as stated below. Also please reconfirm the exact date the variation was submitted to remove my name from the WDA license.
Published: 8 May 2026
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Under the Freedom of Information Act 2000, I am requesting information regarding the GB-PRIME study (ClinicalTrials.gov ID: NCT07127172; IRAS ID: 354112), specifically concerning the Neuralink N1 Brain-Computer Interface and the R1 Surgical Robot. • I request the following information: • The total number of Serious Adverse Events (SAEs) reported to the MHRA in relation to this study from its commencement in the UK through February 2026. • The number of reported incidents of electrode thread retraction or displacement in UK participants. • The number of surgical site infections or secondary surgeries required for any UK trial participants. • A copy of the non-technical summary of the clinical trial authorization, including any specific safety conditions imposed by the MHRA for the UK arm of the study. I understand that personal data is exempt under Section 40, and I am not seeking the identities of any participants. Moreover, while I recognise commercial sensitivity (Section 43), I believe the public interest in the safety of invasive neurological implants outweighs the commercial interest in withholding aggregate safety figures.
Published: 8 May 2026
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Validar si existe el certificado que anexo Translation: Please verify whether the attached certificate exists
Published: 8 May 2026
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I would like to receive information relating to Yellow Card adverse reaction reports received from Wales for GLP-1 medicines, in Excel format. Please provide a breakdown of adverse reaction reports relating to GLP-1 medicines received from Wales since 1st January 2024 per annual year by: * The sex of the patient affected * How many patients in each age group * The number of reports made by healthcare professionals, patients and carers * How many reports were sent directly to the MHRA and how many came via a pharmaceutical company * Seriousness - how many of the reported reactions were fatal, serious and non-serious * A breakdown of seriousness of cases by patient sex, age category and year report was received * A breakdown of seriousness by brand name (eg. Wegovy, Ozempic, Saxenda, Rybelsus and Mounjaro.) * Please also provide a breakdown of each seriousness category by system organ class * For these reported cases, please also provide a breakdown of whether the medication was prescribed by a doctor/other healthcare professional or bought at a pharmacy or online, or from an illegitimate supplier if this information is available. * Separately, please also specifically tell me how many reports of acute pancreatitis have been received from Wales relating to GLP-1 medicines and how many of these have been fatal, broken down by brand. * Also, separately, please also tell me how many reports have been received from Wales relating to falsified GLP-1 medicine for weight loss and any other breakdown you can provide for this data. Please send all of the data in Excel format. I look forward to hearing from you within 20 working days. If there are any issues with my request, please contact me to discuss as soon as possible.
Published: 8 May 2026
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Dear MHRA Team, With reference to our ongoing Freedom of Information (FOI) request (Our Ref: FOI2026/00152), we kindly request the agency to provide the Clinical Overview for the following Marketing Authorisation. Product Name: Doxazosin Tablets 8 mg MAH: Ennogen IP Ltd, UK MA No.: PL 55612/0034 Requested Document: Clinical Overview For the agency’s reference, the FOI response previously received from MHRA has been attached. We would appreciate your assistance in providing the requested document at your earliest convenience. Thank you for your support. Regards, Yogesh Patani
Published: 8 May 2026
