ICH Consultations on Patient Preference, Extractables, and Adaptive Trials

Canada Health Canada Drug Announcements

Published January 12th, 2026

Detected March 13th, 2026

Summary

Health Canada announced three International Council for Harmonisation (ICH) draft guidelines are open for public consultation. The consultations cover patient preference studies, extractables and leachables, and adaptive clinical trials, with comment deadlines ranging from November 2025 to April 2026.

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What changed

Health Canada has announced the opening of public consultations for three draft International Council for Harmonisation (ICH) guidelines. These include ICH E22 on General Considerations for Patient Preference Studies, ICH Q3E on Impurities: Guideline for Extractables and Leachables, and ICH E20 on Adaptive Clinical Trials. These draft guidelines are released for Step 2 consultation, meaning they are available for public comment before further deliberation within the ICH.

Regulated entities, particularly drug manufacturers and pharmaceutical companies, are advised to review these draft guidelines and submit comments. Comments should be submitted to Health Canada via email by the respective consultation end dates: November 28, 2025, for Adaptive Clinical Trials; January 14, 2026, for Extractables and Leachables; and April 12, 2026, for Patient Preference Studies. Organizations can also submit comments directly to ICH through their affiliate associations. Failure to submit comments by the deadlines may result in the loss of an opportunity to influence the final guidelines.

What to do next

Review draft ICH E22, Q3E, and E20 guidelines for potential impact.
Submit comments to Health Canada via email by the respective deadlines (Nov 28, 2025; Jan 14, 2026; Apr 12, 2026).
Consider submitting comments through international affiliate associations if applicable.

Source document (simplified)

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 |
|
Table 1 Footnote 1 The above referenced draft documents were released by the International Council for Harmonisation (ICH) Assembly for consultation and are being posted on the ICH website for information and comment in accordance with the ICH process.

Return to table 1 footnote * referrer

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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