International Council for Harmonisation (ICH)
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|Document||Type of Notice||File Number||Consultation Start Date||Consultation End Date|
|Release of Draft (Step 2) ICH Guideline Q9(R1): Quality Risk Management||Consultation||21-121593-498||January 14, 2022||April 14, 2022|
|Release of Draft (Step 2) ICH Guideline Q2(R2): Revision to Analytical Validation||Consultation||22-104334-3||June 13, 2022||September 13, 2022|
|Release of Draft (Step 2) ICH Guideline Q14: Analytical Procedure Development||Consultation||22-104334-3||June 13, 2022||September 13, 2022|
|Release of Draft (Step 2) ICH Guideline E11A: Paediatric Extrapolation||Consultation||22-104334-3||June 13, 2022||September 13, 2022|
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
Recent/upcoming public consultation meetings
|Topic||Type of Meeting||File Number||Additional Notes|
|Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines||Joint Public Consultation||22-104334-3||
This public consultation for Canadian and U.S. stakeholders took place virtually on May 11, 2022 from 1:00 PM EST to 4:00 PM EST.
Please see below for additional information.
Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint 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 each bi-annual ICH face-to-face meeting, 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 biannual ICH Assembly meeting took place as a hybrid in-person/virtual meeting on May 24th and 25th, 2022. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders took place virtually on May 11, 2022 from 1:00 PM EST to 4:00 PM EST.
Another consultation will be held prior to the next ICH Assembly meeting, which will take place in the fall of 2022. Registration details will be announced when they become available.
For additional information, including Concept Papers and any available draft guidelines for comment, please visit the ICH Website.
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