Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

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657 disclosures

  1. Please provide the independent expert advice on the safety risk of the supply and use of gonadotropin-releasing hormone (GnRH) agonist for puberty suppression in adolescants experiencing Gender incongruence of childhood that was referred to by the Department of Health and Social Care as having been provided to them (see, for example, https://news.stv.tv/scotland/puberty-blockers-for-children-with-gender-dysphoria-to-be-banned-indefinitely-in-uk).

    Published: 17 January 2025

  2. Please can you provide under the Freedom of Information Act a copy of the independent advice used to advise Wes Streeting and the Department of Health and Social Care about the use of GnRH agonist (so-called "puberty blockers") on the risks of such, and the correspondance between contributors that was used in the development of this advice?

    Published: 17 January 2025

  3. Please provide me with all the representations received concerning the recent permanent ban on puberty blockers. Personal data such as name and details of personal circumstances may be redacted. Organisation names should be disclosed.

    Published: 17 January 2025

  4. I contacting today regarding the advice given to Wes streeting the Health Secretary regarding the indefinite ban on puberty blockers for people under the age of 18. It is my understanding that a consultation has taken place and advice has been given. Would it be possible to find out the exact nature of this advice as the terminology used on the government press release is sensationalised and non specific to the field of medicine and care. It was my understanding that the current position was to approach the use of puberty blockers from a position of neutrality. After contacting the British Medical Association I have been informed that the evaluation into the Cass Review is underway and is yet to be complete. The Cass Review has already been reviewed internationally and has been found to have several major flaws and if this is the basis of the indefinite ban this is rather concerning The effect of GNRH agonists are reversible and this has been the case for many years according to NICE guidelines. The science cannot just change overnight without significant evidence. If that is the case can I please see the evidence. If actions are taking place without the complete evaluation of evidence then this is unconstitutional and against human rights. If this is the case then this is a public issue and must be reported as such. Can I have the relevant information I am requesting and receipt of my request.

    Published: 17 January 2025

  5. I refer to your National Safety Alert on bed rails and bed levers. As you rightly identify there are significant risks relating to the provision of these pieces of equipment. My understanding is there are 18 deaths over four years relating to bed levers and bed rails. These cases would have been heard at inquests which are open hearings that could be reported on. I want to review these cases as a learning exercise for our clinical team. Would you be able to provide me with the case report details so I can read the cases and understand how the equipment contributed to patient mortality. I used to work as a solicitor so I would understand the caselaw and how to apply it to clinical practice. We want to do our best for patients and understanding the risks identified by the inquest would help especially with bed levers where mortality seems less clear cut.

    Published: 17 January 2025

  6. PL 43461/0076, Carbimazole 10mg tablets, Flamingo PL 43461/0104, Carbimazole 15mg tablets, Flamingo Under the FOI I would like to request module 2 documents for the above 2 MAs. This includes 2.3.P.1-quality overall summary, 2.4.P-non clinical overview, 2.5.P- clinical overview, 2.7.P- clinical summary

    Published: 17 January 2025

  7. Could you please share the latest full GDP inspection report for: TARGET HEALTHCARE (WHOLESALE) LIMITED, 19 GLENBURN ROAD, EAST KILBRIDE, GLASGOW, G74 5BA, UNITED KINGDOM TARGET HEALTHCARE (WHOLESALE) LIMITED, 8 REDWOOD CRESCENT, EAST KILBRIDE, GLASGOW, G74 5PA, UNITED KINGDOM PRIME PHARMACARE LIMITED, UNIT 25-32 DEVONSHIRE HOUSE, 582 HONEYPOT LANE, STANMORE, HA7 1JS, UNITED KINGDOM CHEMILINES HOUSE, CHEMILINES HOUSE, ALPERTON LANE, WEMBLEY, HA0 1DX, UNITED KINGDOM LOGAN PHARMACEUTICALS LIMITED, 77 DUNN STREET, GLASGOW, G40 3PA, UNITED KINGDOM * OTSUKA PHARMACEUTICALS (UK) LTD, 2 WINDSOR DIALS, ARTHUR ROAD, WINDSOR, SL4 1RS, UNITED KINGDOM * ESTEVE RD UK & IRELAND LTD , THE ROUNDHOUSE, THE COURTYARD BARNS, CHOKE LANE, COOKHAM DEAN, MAIDENHEAD, SL6 6PT, UNITED KINGDOM

    Published: 17 January 2025

  8. Under the freedom of information act I would like to request the following information: - The total number of Yellow Card reports received each year for the years 2010 to 2024

    Published: 17 January 2025

  9. Under the Freedom of Information Act 2000, would it please be possible for you to provide me with following information: What is the headcount (number) of staff employed in communications, marketing, press and public affairs in the British Pharmacopoeia Commission?

    Published: 17 January 2025

  10. In January 2024, the MHRA changed its guidance to doctors who wish to start males aged under 55 on a new course of valproate to treat epilepsy. In September 2024, further guidance to men was issued, which included the need to use contraception if taking valproate, and to stop valproate before trying to father a child. Both measures were based upon the EMA’s safety committee's (PRAC) recommending certain precautionary measures for the treatment of male patients with valproate medicines, based upon a retrospective observational study carried out by companies that market valproate. This study was shared with the MHRA. This post-authorization safety study (PASS) evaluating the paternal exposure to valproate and the risk of neurodevelopmental disorders has the EU PAS number EUPAS34201 and the Study ID: 50599 I would like to request a copy of the above study upon which the MHRA based its decision. Thus far, only an assessment report has been placed in the public domain. (https://www.gov.uk/government/publications/valproate-paternal-exposure-to-valproate-and-risk-of-neurodevelopmental-disorders-and-congenital-malformations-in-offspring)

    Published: 17 January 2025