FOI release

Regulatory Status and Supply of Oestrogen and Testosterone Implants

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 FOI2026/00355

Received 30 March 2026

Published 12 May 2026

Request

Under the provisions of the Freedom of Information Act 2000, I am requesting the following information regarding the regulatory status, supply restrictions, and review process for subcutaneous hormone implants (specifically 25mg and 50mg Oestradiol and Testosterone pellets). 1. Regulatory Status and Patient Access - Please provide the current official MHRA policy regarding the initiation of new patients on oestrogen implant therapy. - Does the MHRA hold any recorded documentation or clinical guidance that mandates a "zero-initiation" policy for new patients in cases where all licensed alternatives have failed? - Please provide the recorded criteria or conditions that must be met for the "existing patients only" restriction to be formally rescinded. 2. Alternative Manufacturers and cGMP Assessments - Is the MHRA currently engaged in an active regulatory review of alternative manufacturers (e.g., manufacturers based in Australia or Europe) for the supply of oestradiol or testosterone implants to the UK market? - Please provide the number of applications or "Special" clinical need requests received or reviewed by the MHRA for imported hormone implants from non-APT facilities between February 2025 and March 2026. 3. Review Status (APT Facility) - Please confirm if the regulatory review regarding implants manufactured at the APT facility is officially concluded. - If the review is ongoing, please provide the most recent recorded "estimated completion date" for this assessment. 4. Continuity of Supply (Stock Levels) - Following the February 2025 update regarding an estimated 18-month supply of existing stock, does the MHRA hold a more recent stock audit or supply forecast for oestrogen implants as of March 2026? - Has a new licensed source or Marketing Authorisation (MA) holder been identified or approved for these products since February 2025? 5. Testosterone Implants - Please provide the current regulatory status of testosterone subcutaneous implants. - Is this specific product subject to the same "existing patients only" supply restriction as oestrogen implants?

Response

See attached

Documents

• FOI2026_00355 (redacted).pdf (1.9 MB)

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