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
Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1
Complete
Schedule detail:
| Event | Start | End |
|---|---|---|
| Comments Submitted to ISPE | 4-Sept | 20-Oct |
| ISPE Comment Lead Team Review | 20-Oct | 3-Nov |
| ISPE RSC Review | 10-Nov | 17-Nov |
| ISPE CEO Review | 19-Nov | 21-Nov |
| Health Authority Deadline | 3-Dec | |
| ISPE Submits Comments | 2- Dec |
View Details
2026 Commenting Calendar - pending