April 16, 2021

Our file number: 21-104774-529

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 next ICH Assembly meeting will take place virtually on May 25^th, 31^st, and June 1^st, 2021. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders will take place virtually on May 14, 2021 from 1:00 PM EST to 4:00 PM EST. 

To register for this consultation, please visit the ICH Public Meeting registration page.

Another consultation will be held this fall prior to the next ICH Assembly meeting, which is expected to take place in the fall of 2021.

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 from the date of this Notice until Wednesday May 12, 2021.

Please submit comments to the following email address: hc.ich.sc@canada.ca.