Want to learn more about the work of the Regulatory Cooperation Council (RCC)?
Check out this Thursday’s webinar on the Common Electronic Submission Gateway RCC initiative.
Wondering what that group does? Well, it’s an initiative to better coordinate Canadian and American regulatory approval of personal care products and workplace chemicals. For more information, check out the 2012 RCC Progress report:
The electronic submission gateway is the foundation that will allow for increased review collaboration between the two regulatory agencies. In terms of project progress, the technical requirements and operational concept review in support of the creation of a Canadian node on the U.S. Electronic Submission Gateway* has been completed and a service agreement allowing the U.S. Food and Drug Administration to implement the node on Health Canada’s behalf is pending approval. When in place, this will allow companies to make online regulatory submissions (e.g. marketing applications / market authorizations for approval of pharmaceutical products) to Health Canada as they currently can to the Food and Drug Administration.
*The U.S. Electronic Submission Gateway is the central transmission point for sending information electronically to the FDA and enables the secure submission of regulatory information for review.