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
Deadline to Submit Comments to ISPE: 18 June
Schedule detail:
| Event | Start | End |
|---|---|---|
| Comments Submitted to ISPE | 5 May | 18 June |
| ISPE Comment Lead Team Review | 20 June | 30 June |
| ISPE RSC Review | 1 July | 17 July |
| ISPE CEO Review | 21 July | 25 July |
| Health Authority Deadline | 30 July | |
| ISPE Submits Comments | 28 July |
EMA: Guideline on the quality aspects of mRNA vaccines
Deadline to Submit Comments to ISPE: 25 August
Schedule detail:
| Event | Start | End |
|---|---|---|
| Comments Submitted to ISPE | 1 May | 25-Aug |
| ISPE Comment Lead Team Review | 25 Aug | 5 Sept |
| ISPE RSC Review | 8 Sept | 18 Sept |
| ISPE CEO Review | 22 Sept | 26 Sept |
| Health Authority Deadline | 30-Sept | |
| ISPE Submits Comments | 29 Sept | |
EC: Revision of Good Manufacturing Practice (GMP) Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)
Deadline to Submit Comments to ISPE: 1 September
Schedule detail:
| Event | Start | End |
|---|---|---|
| Comments Submitted to ISPE | 7 July | 1 Sept |
| ISPE Comment Lead Team Review | 1 Sept | 17 Sept |
| ISPE RSC Review | 17 Sept | 24 Sept |
| ISPE CEO Review | 29 Sept | 6 Oct |
| Health Authority Deadline | 7 Oct | |
| ISPE Submits Comments | 6 Oct | |