Notice: 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 

September 29, 2020

Our file number: 20-113600-98

Health Canada, like other government agencies, is taking the necessary steps to ensure the Agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. As a result, this meeting will be held via webinar only.

Please contact hc.ich.sc@canada.ca with any questions.

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 areas where harmonised ICH guidelines would be beneficial. 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 meeting will take place virtually from November 16-20, 2020. In preparation for this meeting where current ICH guidelines will be discussed, a public consultation for Canadian and U.S. stakeholders will take place on November 6, 2020 from 10:00 AM EST to 1:00 PM ESTStakeholders will only be able to participate by webcast.

To register for this consultation, please visit the ICH harmonisation for better health.

Future consultations will continue to alternate between Canada and the U.S., with the next meeting to be hosted by Health Canada in the spring 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 November 4, 2020.

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

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