Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use

August 25, 2017
Our file number: 17-108523-505

The Canada-United States (U.S.) Regulatory Cooperation Council (RCC) was created in February 2011 to better align the two countries’ regulatory approaches, where possible.

Under the RCC initiative, 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 of current regulatory disharmony and 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 11-16, 2017 in Geneva, Switzerland. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on October 19, 2017 from 9:00 AM until 12:00 PM 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 meetings will continue to alternate between Canada and the U.S., with the next meeting (which is planned to be hosted by the U.S. FDA to occur in the spring of 2018 prior to the spring scheduled ICH meeting (which will be held in June 2018 in Kobe, Japan).

A draft agenda and list of guidelines currently under development or undergoing revision follow below. For additional information including Concept Papers and any available draft guidelines for comment please visit the ICH website.

In advance of the public meeting on October 19, Health Canada and the US FDA are also offering the opportunity for stakeholders to submit comments in writing for consideration by Health Canada and/or the U.S. FDA.  Comments will be accepted from the date of this Notice until October 16, 2017.

Please submit comments to the following email address:

Draft Agenda

Health Canada-US FDA ICH Consultation
October 19, 2017 - 9:00AM - 12:00PM

  1. Opening Remarks/Introductions
  2. Overview of the ICH Process
  3. Overview of MedDRA and MedDRA Points to Consider
  4. Overview of Current Efficacy Topics
  5. Overview of Current Safety Topics
  6. Overview of Current Quality Topics
  7. Overview of Current Electronic Standards Topics
  8. Closing Remarks

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

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