Regulatory Commenting Calendar


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:

EventStartEnd
Comments Submitted to ISPE5 May18 June
ISPE Comment Lead Team Review20 June30 June
ISPE RSC Review1 July17 July
ISPE CEO Review21  July25 July
Health Authority Deadline 30 July
ISPE Submits Comments 28 July

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EMA: Guideline on the quality aspects of mRNA vaccines

Deadline to Submit Comments to ISPE: 25 August

Schedule detail:

EventStartEnd
Comments Submitted to ISPE1 May25-Aug
ISPE Comment Lead Team Review25 Aug5 Sept
ISPE RSC Review8 Sept18 Sept
ISPE CEO Review22 Sept26 Sept
Health Authority Deadline 30-Sept
ISPE Submits Comments 29 Sept
   

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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:

EventStartEnd
Comments Submitted to ISPE7 July1 Sept
ISPE Comment Lead Team Review1 Sept17 Sept
ISPE RSC Review17 Sept24 Sept
ISPE CEO Review29 Sept6 Oct
Health Authority Deadline 7 Oct
ISPE Submits Comments 6 Oct
   

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