International Council for Harmonisation (ICH) 

Draft ICH documents for consultation Table 1 Footnote *
Document Type of Notice File Number Consultation Start Date Consultation End Date
Release of draft (step 2) ICH Guideline Q1: Stability Testing of Drug Substances and Drug Products Consultation 25-102237-854 June 27, 2025 August 31, 2025
Release of draft (Step 2) ICH Guideline M13B: Bioequivalence for Immediate-Release Solid Oral Dosage Forms Consultation 25-102237-854 June 27, 2025 August 31, 2025
Release of draft (Step 2) ICH Guideline M4Q(R2): Common Technical Document (CTD)-Quality Consultation 25-102237-854 June 27, 2025 September 25, 2025
Release of draft (Step 2) ICH Guideline E20: Adaptive Clinical Trials Consultation 25-102237-854 June 27, 2025 September 25, 2025
Release of draft (Step 2) ICH Guideline E21: Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials Consultation 25-102237-854 June 27, 2025 September 25, 2025
Release of draft (Step 2) ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) – Technical Specification Consultation 25-102237-854 June 27, 2025 July 15, 2025
Release of draft (Step 2) ICH Guideline E6(R3) Annex 2: Good Clinical Practice Consultation 24-110987-619 December 20, 2024 March 20, 2025
Release of draft (Step 2) ICH Guideline M15: Model Informed Drug Development Consultation 24-110987-619 December 20, 2024 March 20, 2025

Please note that draft (step 2) guidelines are only available in English; however, guidelines finalised by the ICH will be translated into French and will be made available upon request. It is also important to note that amendments to draft documents may occur as a result of regulatory consultations and subsequent deliberations within the ICH.

All comments forwarded to Health Canada will be transmitted to the ICH as is, with the disclaimer that they are provided for information and do not necessarily represent the views of Health Canada, except as specifically indicated in separate comments.

As appropriate, your organization may alternatively wish to provide comments to your affiliate association internationally for their input directly to ICH.

Please use the ICH template for public consultations to send in your comments. Comments provided to Health Canada should be submitted by the date listed in the table above in order to allow sufficient time for their assessment and subsequent transmission to the ICH.

Comments should be directed to:
Health Canada - ICH Coordinator
E-mail: ich@hc-sc.gc.ca

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