International Council for Harmonisation (ICH) 

Consultations

On this page:

• Draft ICH documents for consultation
• Recent/upcoming public consultation meetings

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

Recent/upcoming public consultation meetings

Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint annual public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to biannual ICH face-to-face meetings, in order to seek input on certain regulatory aspects that could be beneficial for the harmonisation of ICH guidelines. Stakeholder input received through this initiative will be considered in current or future guideline development. Health Canada also intends to use these opportunities to better understand areas in drug product regulation where Canadian requirements may differ from those in place in the U.S., with a view to minimizing these differences.

The next biannual ICH Assembly meeting will take place in Vancouver on June 12th and 13th, 2023. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders will take place virtually on February 24, 2023 from 1:00 PM EST to 4:00 PM EST. To register for this consultation, please visit the registration page.

A draft agenda will be available on the registration page. For additional information, including Concept Papers and any available draft guidelines for comment, please visit the ICH Website.

In advance of the public meeting, Health Canada and the U.S. FDA are also offering the opportunity for stakeholders to submit comments on these guidelines in writing. Comments will be accepted until Wednesday February 22, 2023.
Please submit comments to the following email address: ich@hc-sc.gc.ca.