FOI release
VALPROATE SAFETY: DECISION CHRONOLOGY AND REGULATORY ACTION
This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2026/00940
Received 23 August 2026
Published 7 October 2026
Request
Please provide recorded information held by the MHRA concerning the development of the strengthened valproate safety measures announced on 28 November 2023 and introduced from January 2024. I am seeking to understand the recorded chronology by which relevant safety evidence was identified, assessed, escalated and translated into regulatory action. Please provide: 1 Any chronology, timeline or equivalent document prepared for, or used during, the MHRA/Commission on Human Medicines review of valproate safety in 2022 which records when significant safety evidence or signals were first received, identified or escalated, including in relation to: * reproductive risks * risks associated with exposure during pregnancy * impaired fertility or reproductive effects in male patients * emerging evidence concerning risks associated with paternal exposure * continued prescribing notwithstanding previous safety measures. 2 The earliest internal briefing, assessment, paper or recommendation from the 2021-2023 period which considered materially strengthening the existing regulatory restrictions on valproate. 3 Copies of papers, minutes, decision records or recommendations from the Commission on Human Medicines and/or its relevant expert or implementation working groups during 2022 and 2023 which considered: * whether further restrictions on valproate prescribing were required * the options available * the proposed restriction on initiation in patients under 55 years of age * the requirement for two specialists independently to consider and document whether valproate should be initiated * the proposed timetable for implementation 4 Recorded information setting out the reasons for the timing of the strengthened regulatory measures, including any recorded consideration of: * whether action should have been taken earlier * whether stronger or weaker restrictions should be introduced * advantages, disadvantages or risks associated with alternative regulatory options * reasons for adopting the measures ultimately announced 5 The final decision or approval record authorising the regulatory measures announced on 28 November 2023 and implemented from January 2024. This request is for recorded information only. To assist in keeping the request within the appropriate cost limit, I am not requesting individual Yellow Card reports, patient-level information, routine administrative correspondence or duplicate copies of documents. Where a document is already publicly available, I am content for the MHRA to identify it by title and link. However, the request includes any underlying non-public paper, minute, briefing, recommendation or decision record which is not contained in the published material. If information within a document is exempt, I should be grateful if the exempt material could be redacted and the remainder disclosed with the exemption relied upon identified.
Response
See attached
Documents
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