International Council for Harmonisation (ICH)
| Document | Type of Notice | File Number | Consultation Start Date | Consultation End Date |
|---|---|---|---|---|
| Release of draft (step 2) ICH E22: General Considerations for Patient Preference Studies | Consultation | 25-108149 - 635 | January 12, 2026 | April 12, 2026 |
| Release of draft (step 2) ICH Guideline Q3E: Impurities: Guideline for Extractables and Leachables | Consultation | 25-105890 – 674 | October 17, 2025 | January 14, 2026 |
| Release of draft (Step 2) ICH Guideline E20: Adaptive Clinical Trials | Consultation | 25-102237-854 | June 27, 2025 | November 28, 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