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Published: 6 November 2026
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Under the Freedom of Information Act 2000, I'm writing to request access to specific recorded data, internal communications, and decision-making records held by the MHRA regarding the regulation and safety monitoring of fluoroquinolone antibiotics. Please find my detailed, itemised queries listed below for your review within the statutory 20-working-day timeframe. Thank you. 1. Please provide the specific recorded data, epidemiological studies, or statistical models used by the MHRA to calculate and conclude that the minimum frequency of disabling fluoroquinolone side effects is between 1 and 10 per 10,000 patients (the ‘rare’ classification), as published in the January 2024 Drug Safety Update. Please provide: a) Any internal assessments, reports, or statistical adjustments held by the MHRA regarding the estimated underreporting rate to the Yellow Card Scheme for fluoroquinolone-associated disability (FQAD). b) Any recorded risk-benefit evaluations or safety committee papers discussing how the lack of a specific NHS SNOMED or ICD-10 diagnostic code for FQAD impacts the MHRA’s ability to capture the true clinical incidence of these adverse events. c) The official confidence intervals or sensitivity analyses recorded in the MHRA's safety reviews regarding the accuracy of this "rare" statistical incidence. 2. Please share correspondence and shared data between the MHRA and the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) between 2016 and 2024 regarding safety signals for peripheral neuropathy and aortic aneurysm risks in fluoroquinolones. 3. Please provide minutes of meetings, scientific rationales, and internal correspondence from the Commission on Human Medicines (CHM) or MHRA safety committees regarding the decision to update the estimated incidence of disabling side effects from very rare (2019) to a minimum frequency of 1 to 10 per 10,000 patients in the January 2024 update. 4. Please provide copies of all official correspondence, guidance documents, letters, and alerts sent by the MHRA to healthcare professionals, clinical bodies, and NHS organisations regarding the implementation of safety restrictions on fluoroquinolone antibiotics, regarding both the March 2019 Drug Safety Update and the January 2024 Drug Safety Update. Specifically, any direct alerts, DHPCs, or implementation guidance sent to clinical networks, Royal Colleges, or NHS Trusts regarding the initial introduction and the subsequent tightening of these prescribing restrictions. 5. Please provide the internal documentation, meeting minutes, and scientific rationales concerning the decision-making process to issue the August 2023 Drug Safety Update reminder regarding the March 2019 fluoroquinolone restrictions. Specifically, include: 1. Minutes of meetings held by the Commission on Human Medicines (CHM) or its expert advisory groups where the necessity of an August 2023 safety reminder was discussed 2. Any reports, statistical data summaries, or influxes of Yellow Card adverse drug reaction (ADR) reports reviewed by the MHRA between January 2022 and August 2023 that prompted the decision to issue this specific reminder. 6. Please provide a complete breakdown of all Yellow Card adverse drug reaction (ADR) reports for systemic fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) from 2019 to 2025, specifically broken down by patient age groups, gender, and the duration of the reported disability. 7. Please provide any internal reviews, audits, or data held by the MHRA assessing clinical compliance with the January 2024 Drug Safety Update restrictions on fluoroquinolones, including data on overall UK prescribing volume drops before and after the alert. 8. Please clarify the internal organizational structure of the MHRA by identifying the specific Divisions, Units, or Expert Advisory Groups currently responsible for: 1. The final regulatory decision-making process to restrict fluoroquinolone antibiotics (including the specific expert committees or panels involved in reviewing the benefit-risk profile). 2. The post-marketing surveillance and active collection of data (such as Yellow Card adverse drug reaction reports and real-world data networks) used to identify safety signals and inform these restrictions. 3. The dissemination of updated drug safety advice and restrictions directly to frontline clinicians and professional medical bodies (such as the team responsible for publishing the monthly Drug Safety Update and distributing Direct Healthcare Professional Communications). 9. Please clarify the MHRA’s role, policy, and internal process regarding the request or introduction of new clinical diagnostic codes (such as SNOMED CT or ICD-10 terms) within UK clinical practice. Specifically, please provide: 1. Any documentation or standard operating procedures detailing how the MHRA interacts with NHS England’s Terminology and Classifications Delivery Service to request new codes following severe drug safety signals. 2. Details of any active or past requests made by the MHRA to NHS England between 2019 and 2024 to establish unique diagnostic codes specifically related to fluoroquinolone-induced toxicity or long-term adverse events.
Published: 6 November 2026
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I am writing to submit a Freedom of Information request under the Freedom of Information Act 2000 concerning the following medicinal product: • Product: Ethosuximide 250 mg/5 ml Oral Solution • PL Number: PL 34424/0087 • Marketing Authorisation Holder: Key Pharmaceuticals Having reviewed the MHRA Public Assessment Report (PAR) for this product, I understand that the marketing authorisation application was submitted under the applicable Regulation 10.1 procedure I would therefore be grateful if the MHRA could provide copies of the clinical and non-clinical overviews submitted in support of the marketing authorisation application for PL 34424/0087.
Published: 6 November 2026
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I am writing to request information held by the Medicines and Healthcare products Regulatory Agency (MHRA) concerning suspected adverse drug reactions (ADRs) reported through the Yellow Card Scheme in relation to medroxyprogesterone acetate (MPA). I understand that the MHRA has previously confirmed that detailed, appropriately anonymised Yellow Card information can be disclosed under the Freedom of Information Act. I am therefore seeking aggregate statistical information rather than any personally identifiable information. For clarity, I am requesting data relating to the active substance medroxyprogesterone acetate, rather than limiting the search to the individual brand name Depo-Provera. This is important because medroxyprogesterone acetate is used in different products and formulations, including Depo-Provera and Sayana Press, and I wish to understand the full pharmacovigilance reporting history associated with the substance. 1. Total number of Yellow Card reports Please provide the total number of UK Yellow Card reports of suspected adverse reactions associated with medroxyprogesterone acetate, from the earliest date for which records are available up to and including 31 August 2026. Please provide the figures cumulatively as well as, where possible, broken down by calendar year. 2. Annual breakdown Please provide the number of suspected ADR reports involving medroxyprogesterone acetate for each calendar year, from the earliest available year through to 31 August 2026. If the data are available in a different reporting period or format, please provide the closest equivalent and explain the period used. 3. Breakdown by suspected adverse reaction Please provide the number of reports associated with each suspected reaction/reaction term recorded against medroxyprogesterone acetate. In particular, I would like the following categories specifically identified where they are present within the Yellow Card data: - Meningioma - Multiple meningiomas - Intracranial tumour - Brain tumour - Other central nervous system/neoplastic disorders - Neurological disorders - Visual disorders - Headache - Migraine - Seizures/convulsions - Pituitary disorders - Cognitive disorders - Memory disorders - Psychiatric disorders - Mood disorders - Muscle atrophy - Lipodystrophy - Osteoporosis - Other bone disorders - Diabetes/metabolic disorders - Thromboembolic disorders - Cerebrovascular disorders Where the MHRA uses a specific MedDRA Preferred Term (PT), Lowest Level Term (LLT), System Organ Class (SOC), or other coding terminology rather than the wording above, please provide the corresponding coded term and explain the classification used. I am particularly interested in ensuring that reports are not excluded simply because the reporter used wording such as "brain tumour", "intracranial tumour" or "multiple meningiomas" rather than the exact term "meningioma". 4. Product/brand information Where this information is held, please provide a breakdown of reports according to the suspected product/formulation, including: - Depo-Provera - Sayana Press - Other injectable medroxyprogesterone acetate products - Oral medroxyprogesterone acetate products If the MHRA's database does not permit a direct brand-level breakdown, please state this clearly and provide the closest available breakdown. 5. Route of administration Please provide the number of reports according to route of administration, where recorded, including: - Intramuscular - Subcutaneous - Oral - Other/unknown 6. Seriousness of reports Please provide the number of reports classified as serious and non-serious, where this classification is available. If possible, please also provide the number of serious reports associated specifically with meningioma. 7. Reporter type Please provide the number of reports according to reporter type, where recorded, including: - Patient/member of the public - Healthcare professional - Pharmaceutical company/manufacturer - Other reporter type - Unknown/not recorded Again, I would particularly welcome this breakdown for reports involving meningioma. 8. Reported outcomes Where available, please provide aggregate information concerning the reported outcome of the suspected ADR, including: - Hospitalisation - Life-threatening reaction - Disability/incapacity - Congenital abnormality - Fatal outcome - Recovery - Recovering - Not recovered - Recovered with sequelae - Unknown/not recorded I am particularly interested in the outcomes associated with reports of meningioma and multiple meningiomas. 9. Meningioma reports – before and after the October 2024 safety communication Please provide the number of Yellow Card reports concerning meningioma associated with medroxyprogesterone acetate received: a) before the MHRA/Pfizer safety communication issued in October 2024; and b) from the date of that communication through to 31 August 2026. If possible, please provide this as a year-by-year cumulative or annual breakdown so that the reporting pattern before and after the safety communication can be examined. For example: Period| Number of meningioma reports Earliest available year – 2023| 2024, before October communication| October–December 2024| 2025| 1 January–31 August 2026| If the MHRA holds the information in a form that permits a more precise comparison, please provide that instead. 10. Historical cumulative meningioma reports Please provide, if available, the annual cumulative number of meningioma reports associated with medroxyprogesterone acetate, from the earliest recorded report through to 31 August 2026. I am specifically seeking to establish how the number of reported cases has developed over time and whether there was any change in reporting following the recognition and communication of the meningioma risk. 11. Multiple meningiomas Please separately identify, where possible, reports in which multiple meningiomas were reported. If multiple meningiomas are not separately coded from meningioma generally, please confirm this and provide the relevant coding/category used by the MHRA. 12. Historical changes in coding or reporting If there have been changes to the coding, terminology, reporting system, product categorisation or treatment of medroxyprogesterone acetate ADR reports during the period covered by this request that could affect comparison of historical and current figures, please provide details of those changes. 13. Publicly available information I appreciate that some Yellow Card information is available through the MHRA's public reporting tools, including iDAP. However, this request is specifically for aggregate historical information and cross-tabulated data held by the MHRA, including annual figures, reaction-specific figures, meningioma figures, pre- and post-October 2024 comparisons, seriousness, reporter type, route and product/formulation where available. I am therefore not requesting that I simply be directed to the publicly available iDAP search facility. If any part of the information requested above is already publicly available, please identify precisely which information is available and provide the corresponding publication/database reference. I would nevertheless be grateful for the additional aggregate information requested above where it is held by the MHRA. 14. Data limitations If any of the requested breakdowns cannot be provided because the MHRA does not routinely record the information, please specify which elements are unavailable rather than treating the entire request as unavailable. If some of the requested information would exceed the appropriate cost limit, please provide the information that can be supplied within the limit and advise which elements would need to be narrowed or reformulated. I am happy for the information to be supplied electronically, preferably in Excel, CSV or another machine-readable format, where possible. I confirm that I am seeking aggregate, anonymised statistical information only and do not require any patient-identifiable information. This request is being made to assist with research into the long-term pharmacovigilance history of medroxyprogesterone acetate, particularly in relation to meningioma and the development of the recognised safety information surrounding prolonged exposure. Thank you for your assistance. I look forward to your response within the statutory timeframe.
Published: 6 November 2026
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Please treat this email as a request under the Freedom of Information Act 2000. Please provide any record held by the MHRA confirming the CE-certification status on 28 March 2012 of the following breast implants: * Allergan Natrelle INSPIRA TRX * Catalogue references N-TRX340 and N-TRX375 * Notified body: GMED 0459 If the certificate itself cannot be provided, please confirm: 1. The relevant certificate number; 2. Its period of validity; and 3. Whether N-TRX340 and N-TRX375 were covered by a valid CE certificate on 28 March 2012. This information is required to verify the historical regulatory status of these medical devices. Please provide the information electronically by return email.
Published: 6 November 2026
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I want to raise a matter of concern regarding apparently inconsistent information provided in response to similar FOI requests I am aware you are under huge pressure to provide many answers to many people in time constraints. However I must draw your attention to a significant inconsistency in your public responses about the same subject matter. In FOI2024_00390 redacted for publication the question is As the MHRA informed the public on 2 December 2020 in the summary of the public asessment report, BioNTech's BNT162b2 mrna covid vaccine was manufactured 'through fermentation in an established and well-controlled Escherichia coli cell line, extracted and purified.' The purification method used by BioNTech to manufacture process 1 product which was used during the phase 1, 2 and 3 clinical trials was not scalable and could not be used to manufacture the mass manufactured process 2 product supplied to the UK under the December 2020 Regulation 174 authorisation. How did the MHRA establish that batch EJ-0553 and the other Regulation 174 batches were free of e-coli toxin (endotoxin) contamination in order to ensure that they were safe? If it was not free of e-coli endotoxin, on what scientific basis did the MHRA determine that the endotoxin was at a safe level? And who conducted the endotoxin testing of the Regulation 174 batches for the MHRA (eg was it the NIBSC or the manufacturer of the product? Please provide the endotoxin values as tested by the NIBSC for the following batches of BNT162b2 n Batch number 1NIBSC certificate issued on: 1 EJ0553 2.12.20 2 EJ0724 7.12.20 3 EJ1688 7.12.20 4 EL0141 7.12.20 5 EL0739 14.12.20 6 EK1768 17.12.20 7 EK4243 18.12.20 8 EK4237 21.12.20 9 EE8492 21.12.20 10 EE8493 21.12.20 Given the known risks of e-coli toxins, if no independent testing for e-coli endotoxin was commissioned by the MHRA for BNT162b2, please provide copies of any written policy statements or rationals explaining or justifying why such testing was deemed unnecessary. MHRA Response - Testing of batches of the Pfizer/BioNTech Covid-19 vaccine authorised under Regulation 174 was performed by the National Institute for Biological Standards and Control (NIBSC) to ensure that the batches were within specification limits defined during the assessment of this vaccine. The results of the tests performed by NIBSC are commercially sensitive and are, therefore, exempt from disclosure under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act. That implies very strongly that NIBSC tested Batch EJ0553 and the rest of bnT162b2 batches for endotoxin level. If so, that reply contradicts the interim rely sent to me. The further evidence of contradiction is the Batch release certificate also supplied . This shows the manufacturer not NIBSC performed the endotoxin active substance test. The certificate of release does not provide a result only a limit. The letter sent to me did not list the endotoxin test as an IBSC requirment. In order to clear up this matter, please confirm that NIBSC did not test the batch EJ0553 for endotoxin and only performed the five tests you state it ran in your reply to me. New supplementary question Please also provide evidence if held of confirmation that NIBSC/MHRA had in place a validation of the LAL testing method to detect masked endotoxin (l ow endotoxin recovery) in active substance chelated by EDTA added to the product. EDTA is referenced in the EMA EPAR. If not, was that validation requirement waived by the letter of no objection, responding to the Pfizer endotoxin test result provided to NIBSC in the redacted certificate for EJ0553
Published: 6 November 2026
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Could you please advise regulatory pathway, RLD used, and available Mod 4/5 data for Nifedipine 10 mg capsules as shared 5mg is lower strength.
Published: 6 November 2026
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I refer to MHRA response FOI 23/211 dated 23 March 2023 concerning the imbalance in important protocol deviations in the pivotal Pfizer/BioNTech BNT162b2 clinical trial. That response stated that no formal investigation of the imbalance was undertaken but that the imbalance was noted during assessment but was not pursued because the proportions were considered low. 1.4% in the BNT162b2 group and 0.3% in the placebo group. Please provide the following recorded information only: 1 Copies of any contemporaneous MHRA assessment records, reviewer comments, assessment reports, notes, emails, meeting records or other documents recording or discussing the imbalance in important protocol deviations between the BNT162b2 and placebo groups. 2 Copies of any recorded analysis or consideration of whether that imbalance could have affected: a) the primary efficacy analysis b) the comparability of the randomised groups c) exclusion of participants from the evaluable efficacy population d) blinding or allocation integrity e) the reliability of the reported vaccine-efficacy estimate. 3 Copies of any recorded risk assessment, regulatory reasoning, criteria or other documentation supporting the decision that the imbalance did not require formal investigation or further pursuit. 4 Please provide any recorded sensitivity analysis, alternative analysis or other calculation undertaken by or supplied to MHRA examining whether exclusion or inclusion of participants affected by these protocol deviations altered the efficacy findings. 5 FOI23/211 stated that Pfizer subsequently provided an explanation that the imbalance largely reflected investigational-product handling requirements including ultra-low temperature storage, dilution and temperature excursions. Please provide: a) the date on which MHRA requested that information from Pfizer b) a copy of MHRA's request c) a copy of Pfizer's response d) any MHRA assessment, correspondence, notes or other recorded information considering whether Pfizer's explanation was independently verified or regarded as sufficient. 6 Please provide any recorded information showing whether MHRA examined the individual categories of protocol deviation before concluding that the overall imbalance was not significant enough to warrant investigation rather than relying solely on the overall percentages of 1.4% and 0.3%. For avoidance of doubt, I am not requesting the participant-level protocol-deviation lists already disclosed in connection with FOI 23/211 and I do not seek the creation of new analysis or explanations. I am seeking only recorded information already held concerning MHRA's regulatory consideration of this known imbalance and its decision not to investigate it formally. Where no recorded information falling within any particular part of this request is held, please state this explicitly.
Published: 6 November 2026
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I am writing to make a Freedom of Information request regarding adverse reactions, specifically allergic and hypersensitivity reactions, associated with botulinum toxin products used in the UK. I would like the MHRA to provide the most complete and up-to-date data held by the agency, preferably from the Yellow Card reporting system and any other relevant pharmacovigilance databases. Please provide the following: The total number of UK Yellow Card reports associated with botulinum toxin products, broken down by individual product/brand where possible (for example, Botox/Vistabel, Azzalure, Bocouture, Nuceiva and other authorised botulinum toxin products). Of these reports, the number specifically classified or coded as: • allergic reaction • hypersensitivity • anaphylaxis • anaphylactic shock • angioedema • urticaria/hives •facial swelling • swelling of the lips, tongue or throat bronchospasm or breathing difficulty where recorded as an allergic/hypersensitivity reaction other suspected immune-mediated reactions. Please provide the number of reports involving serious reactions, including those resulting in: hospitalisation emergency treatment life-threatening events intensive care admission disability death. Please provide the data broken down by: botulinum toxin product/brand & year of report. therapeutic versus cosmetic use, where this information is available age group, where disclosure is possible. sex, where disclosure is possible. Please provide the number of reports where the reaction occurred after a cosmetic administration of botulinum toxin. Please provide any data held by the MHRA concerning suspected allergic or hypersensitivity reactions following repeat exposure to botulinum toxin, including cases where the individual had previously received the same or another botulinum toxin product without an apparent reaction. Please state whether the MHRA holds information concerning the time between administration of botulinum toxin and onset of an allergic or hypersensitivity reaction. If so, please provide aggregated data showing the reported time to onset. Please provide the number of reports in which the botulinum toxin product was considered the suspected medicine, as opposed to a concomitant medicine or another suspected cause. Please provide any information held regarding the number of these reports that were subsequently assessed by the MHRA as potentially related to the botulinum toxin product. Please provide the reporting period covered by the data and the date on which the data were extracted. I would also like clarification regarding under-reporting. The MHRA has previously stated that Yellow Card reporting is a spontaneous reporting system and that the indication for use is not necessarily recorded on every report. I would therefore like to know: • Whether the MHRA has made any assessment of the likely level of under-reporting of allergic or hypersensitivity reactions to botulinum toxin. • Whether the MHRA has any estimated figures for the true number of allergic reactions compared with the number reported through Yellow Card. • Whether the MHRA has identified any particular limitations in using Yellow Card data to establish the incidence or prevalence of allergic reactions to cosmetic botulinum toxin. Please provide the information electronically, preferably in spreadsheet/CSV format where possible. I am specifically requesting aggregated statistical information and am not requesting personal information relating to individual patients. If any part of this request is considered exempt from disclosure, please provide the remainder of the information and identify the specific exemption being relied upon. I would also be grateful if you could distinguish between: (a) the number of reports received, (b) the number of individual suspected reactions/events recorded within those reports, and (c) any cases that have subsequently been medically assessed or investigated by the MHRA. I understand that a Yellow Card report represents a suspected adverse reaction and does not necessarily establish that the medicine caused the reaction. I am therefore requesting the underlying reported data and any available MHRA assessment rather than assuming causation. Please treat this correspondence as a formal Freedom of Information request.
Published: 6 November 2026
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Thank you for your response regarding FOI requests FOI2026/00814 and FOI2026/00815. In accordance with your request to reduce the scope of the FOI request, I confirm that I would like to proceed with FOI2026/00815 only, relating to the following Marketing Authorisation: Marketing Authorisation Holder: Dawa Ltd Product: Cyanocobalamin 50 microgram Film-coated Tablets PL Number: 30684/0243 FOI Reference: FOI2026/00815 The information requested remains limited to Module 2.4, Module 2.5 and Module 2.7 submitted in support of the above Marketing Authorisation. Please proceed with the processing of FOI2026/00815 on this reduced scope. Thank you for your assistance.
Published: 6 November 2026
