ISPE’s commenting process is overseen by ISPE’s Regulatory Steering Council (RSC). The RSC welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE.
- The Regulatory Steering Council (RSC) determines whether the document falls within the scope of ISPE commentary
- A team of subject matter experts are convened to lead the comment development
- Final comments are vetted by ISPE regulatory leadership prior to submission
- For questions on any of the commenting projects below, please contact regulatorycomments@ispe.org
2025 Commenting Calendar
EMA/ ICH: ICH Harmonised Guideline Stability Testing of Drug Substances and Drug Products Q1
| Event | Start | End |
|---|---|---|
| Call for comments Period | 5-May | 18-June |
| Comments to comment lead team | 20-June | 20-June |
| Comment lead team review | 20-June | 30-June |
| Final Reviewer | 1 July | 17-July |
| Staff sends to CEO | 18-Jul | 18-Jul |
| CEO Review | 21-Jul | 25-Jul |
| Submit Comment to Agency Deadline | 28-Jul | 29-Jul |
EMA: Guideline on the quality aspects of mRNA vaccines
| Event | Start | End |
|---|---|---|
| Call for comments Period | 7_ April | 25-Aug |
| Comments to comment lead team | 25- Aug | |
| Comment lead team review | 25-Aug | 5-Sept |
| Final Review | 8-Sept | 18-Sept |
| Team sends to CEO | 22-Sept | |
| CEO Review | 22-Sept | 26-Sept |
| Agency Deadline | 20-Sept | |
| Call for comments Period | 7_ April | 25-Aug |