Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation (ICH) Guidelines

July 10, 2018

Our file number: 18-108074-902

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 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 10-15, 2018 in Charlotte, North Carolina, USA. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on October 17, 2018 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 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 2019 prior to the ICH meeting which will be held in June 2019).

A draft agenda follows. 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 17, 2018, Health Canada and the U.S. FDA are also offering the opportunity for stakeholders to submit comments in writing. Comments will be accepted from the date of this Notice until October 14, 2018.

Please submit comments to the following email address: HPFB_ICH_DGPSA@hc-sc.gc.ca

Draft Agenda

Health Canada – U.S. FDA ICH Consultation

October 17, 2018 – 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

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: