FOI release

MHRA letter dated 7 November 2025 re PATHWAYS clinical trial

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00196

Received 24 February 2026

Published 12 May 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Please provide a copy of the MHRA letter dated 7 November 2025 that is referenced in correspondence with the sponsor of the PATHWAYS clinical trial (relating to puberty blockers / GnRH analogues in children and young people). If the full letter cannot be disclosed, I request that you provide: 1. The full text with any personal data appropriately redacted; or 2. If any exemptions are applied, a copy of the letter with exempted material redacted, together with a clear explanation of which exemptions have been relied upon and why; and 3. Any covering note or summary document produced by MHRA that describes the content, purpose, or regulatory concerns raised in the letter. I am seeking this information in the public interest, as the PATHWAYS trial is a matter of significant public, clinical, and ethical interest. Please provide the information electronically by email. If my request is too broad or would exceed the cost limit, I would be grateful if you could advise how it might be refined so that some or all of the information can be disclosed.

Response

See attached

Documents

• 2.03 CTA Acceptance of Amended Request (14) (redacted).pdf (525.4 KB)
• FOI2026_00196 (redacted).pdf (817.5 KB)

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