Public comment period · §3
Draft monograph: Sermorelin — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-SERMORELIN-M/001 | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-SERMORELIN-M/002 | Dr Perpetua Haverkamp-Diallo industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-SERMORELIN-M/003 | Dr Hortensia Larsson-Ekwueme | Local reactions are omitted from the adverse-event table because the trials reported them separately | Accepted |
| DRAFT-SERMORELIN-M/004 | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-SERMORELIN-M/005 | Dr Rurik Haverkamp-Diallo | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-SERMORELIN-M/006 | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-SERMORELIN-M/007 | Dr Oswin Yorkstone | The supply section does not record that endotoxin is not determined | Accepted |
| DRAFT-SERMORELIN-M/008 | Dr Liesbeth Nyquist-Obiora | Guidance on lyophilised storage is missing | Noted, no amendment |
| DRAFT-SERMORELIN-M/009 | Dr Emiliana Ollerenshaw | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 1 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 3 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 0 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-SERMORELIN-M/001. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-SERMORELIN-M/002. The approved indication and contraindications are now reproduced verbatim from the named authorisation with its version and date, and the posology section reports the labelled schedule and the schedules studied side by side, with the source of each stated.
- Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-SERMORELIN-M/003. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
- The compound is supplied under names the monograph does not list — arising from DRAFT-SERMORELIN-M/004. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SERMORELIN-M/006. Every regulatory status statement now names the authority, states the date on which the status was verified, and is recorded per jurisdiction rather than as a single global assertion.
- The supply section does not record that endotoxin is not determined — arising from DRAFT-SERMORELIN-M/007. Section 8 now carries an explicit endotoxin line for every compound supplied in an injectable presentation, and states plainly that an undetermined attribute is undetermined rather than acceptable.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-075/3 · https://compoundevidence.com/comment-periods/draft-sermorelin-monograph/disposition/ · retrieved 30 July 2026