FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

By: Lou Valdez, M.S.M.

For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).

Lou ValdezThe RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.

In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.

In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:

  • Food Safety
  • Medical Devices
  • Over-the-Counter Drug Products
  • Pharmaceutical and Biological Products, and
  • Veterinary Drugs.

Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.

Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

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