Draft safety review: the rodent thyroid C-cell signal and its human relevance
Consultation on the draft safety review of the rodent thyroid C-cell signal observed with glucagon-like peptide-1 receptor agonists and its relevance to humans. The review assesses the mechanistic evidence for a species difference in C-cell receptor…
§1Consultation and window
§1.1Window
- Opened
- 20 April 2025
- Closed
- 20 May 2025
- Duration
- 30 days
- Status
- Closed — the disposition is published
- Document under consultation
- Synthesis: The rodent thyroid C-cell signal and its human relevance
- Submissions received
- 16
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the treatment of the rodent finding proportionate, given that it drives a contraindication carried in labelling across the class?
- Is the human evidence, which is drawn from registries and pharmacovigilance databases rather than from trials, characterised correctly as to what it can and cannot establish?
- Should the review state a conclusion on human relevance at all, given the certainty it assigns?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The review was amended before ratification. It states that the human relevance of the rodent signal is not established rather than that it is absent, a distinction several respondents pressed, and the registry evidence is now reported with its detection limits stated.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.