2024-07-24 16:10:00
consult
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Please note that the draft guideline (Step 2) is only available in English; however, the ICH finalized guideline will be translated into French and available upon request. It is also important to note that revisions to the draft document may be made following regulatory consultation and subsequent deliberations within ICH.
All comments sent to Health Canada will be forwarded unchanged to ICH with the disclaimer that these comments are for informational purposes only and do not necessarily represent the views of Health Canada (unless otherwise stated in an individual comment).
As an alternative, your organization may wish to submit comments to your international member association to provide feedback directly to ICH.
please use ICH Model for Public Consultation (English version only) Send your comments. Comments should be submitted to Health Canada before The dates shown in the table above to allow sufficient time for their evaluation and subsequent transmission to the ICH.
Please send your comments to:
Health Canada – ICH Coordinator
Email: ich@hc-sc.gc.ca
Recent and upcoming public consultation meetings
Health Canada and the U.S. Food and Drug Administration (FDA) hold annual joint public consultation meetings on the International Committee for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance currently in circulation. The initiative aims to hold public consultation sessions before the biannual ICH meetings to obtain feedback on certain aspects of the regulations, which may benefit the harmonization of ICH guidelines. As part of this program, comments received from interested parties will be considered in the current or future development of these guidelines. Health Canada also intends to use these opportunities to better understand areas of drug regulation where Canadian requirements differ from U.S. requirements in order to reduce these differences.
The last semi-annual meeting of the ICH General Assembly will be held on June 4-5, 2024 in Fukuoka, Japan. February 22, 2024 (EST) 11 a.m. to 3 p.m..
The meeting agenda and minutes are available at Registration page (English version only). For more information, including discussion papers and draft guidance available for comment, please visit ICH website (English only).
For all inquiries please email:ich@hc-sc.gc.ca.
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