2024-05-24 17:33:00
seek the advice of
On this web page:
Please word that the draft guideline (Step 2) is simply obtainable in English; nevertheless, the ICH finalized guideline can be translated into French and obtainable upon request. It’s also necessary to notice that revisions to the draft doc might also be made following regulatory session and subsequent deliberations inside ICH.
All feedback despatched to Well being Canada can be forwarded intact to ICH with the disclaimer that these feedback are for informational functions solely and don’t essentially signify the views of Well being Canada (until in any other case said in a person remark).
As a substitute, your group might want to submit feedback to your worldwide member affiliation to offer suggestions on to ICH.
please use ICH Mannequin for Public Session (English model solely) Ship your feedback. Feedback ought to be submitted to Well being Canada earlier than The dates proven within the desk above to permit ample time for his or her analysis and subsequent transmission to the ICH.
Please ship your feedback to:
Well being Canada – ICH Coordinator
Electronic mail: ich@hc-sc.gc.ca
Latest and upcoming public session conferences
Well being Canada and the U.S. Meals and Drug Administration (FDA) maintain annual joint public session conferences on the Worldwide Committee for Harmonization of Technical Necessities for Prescription drugs for Human Use (ICH) steering at present in circulation. The initiative goals to carry public session periods earlier than the biannual ICH conferences to acquire suggestions on sure features of the laws, which can profit the harmonization of ICH tips. As a part of this initiative, feedback acquired from events can be thought of within the present or future improvement of those tips. Well being Canada additionally intends to make use of these alternatives to raised perceive areas of drug regulation the place Canadian necessities differ from U.S. necessities so as to scale back these variations.
The following ICH Normal Meeting member assembly can be held on June 4-5, 2024 in Fukuoka, Japan. February 22, 2024 (EST) 11 a.m. to three p.m..
The assembly agenda and minutes can be found at Registration web page (English model solely). For extra info, together with dialogue papers and draft steering obtainable for remark, please go to ICH web site (English solely).
For all inquiries please ship an electronic mail to:ich@hc-sc.gc.ca.
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