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April 09 , 2019

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 June 1-6, 2019 in Amsterdam, the Netherlands. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on April 29, 2019 at 10:00AM at the Building 31 Conference Center, Rm. 1503 (Great Room), 10903 New Hampshire Ave. Silver Spring, MD, USA. 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 Health Canada in the Fall of 2019.

A draft agenda is available via 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 on April 29, 2019, 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 April 26, 2019.

Please submit comments to the following email address:

This notice has been provided on behalf of N2.

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