Draft standard CEI-MS-20: Photostability assessment of light-sensitive peptides
Consultation on the draft of CEI-MS-20, which specifies the performance a determination must achieve for stability and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed procedure, following the…
§1Consultation and window
§1.1Window
- Opened
- 18 April 2026
- Closed
- 17 June 2026
- Duration
- 60 days
- Status
- Closed — the disposition is published
- Document under consultation
- Standard CEI-MS-20
- Submissions received
- 4
§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.
- Are the system suitability criteria appropriate across the range of materials in scope?
- Is the classification of any field as critical rather than recommended disproportionate?
- Does the standard state clearly enough what a determination made under it does not establish?
§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
Amendments arising from the consultation were applied before ratification. Where the secretariat declined to accept a submission, the reason is recorded on the disposition page and the submission remains published in full.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.