FOI release
Liver on a chip in pre clinical trials
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 FOI2025/01330
Received 24 December 2025
Published 5 February 2026
Request
Dear Medicines and Healthcare Products Regulatory Agency, Under the Freedom of Information Act 2000, I request the following held information from 1 July 2024 to the present: 1. Any internal or external correspondence, meeting notes, assessments, or reports discussing the potential recommendation or qualification of **liver-on-a-chip** (or liver microphysiological systems) as a recommended or complementary tool alongside animal testing for preclinical hepatotoxicity assessment (e.g., drug-induced liver injury prediction) in regulatory submissions. 2. Details of any MHRA engagement with international developments on non-animal methods, including: - The US FDA Modernization Act 2.0 (2022) and 2025 FDA roadmap promoting microphysiological systems. - The EU Proposal for a Regulation on Biotechnology and Biomanufacturing (adopted December 2025). - Ongoing ICH discussions on new approach methodologies (NAMs) or non-animal alternatives in safety guidelines. 3. Any identified barriers, plans, or timelines for the MHRA to recommend or qualify liver-on-a-chip platforms in line with the UK Government's November 2025 strategy on replacing animals in science. This request follows a previous unhelpful FOI response earlier in 2025. Please exclude information already provided in that response and focus on post-July 2024 material. If needed, advise on refining to stay within cost limits. I prefer electronic format.
Response
See attached
Documents
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