Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on ICH Guidelines - Update

August 6, 2019
Our file number:
19-113414-359

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 face-to-face meeting will take place from November 16-21, 2019 in Singapore. 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 4, 2019 at 1:00 PM to 4:00 PM EST at the Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, Ontario. Stakeholders will also be able to participate by webcast (information to follow). Registration is to be completed online.

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

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 in November, 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 November 1st, 2019.

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

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