Regulatory Focus™ > News Articles > FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation

FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation

Posted 03 June 2015 | By Alexander Gaffney, RAC

FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation

US and Canadian healthcare product regulators are continuing to move forward in a joint effort to harmonize the way in which both countries regulate pharmaceuticals, medical devices, biological products and veterinary drugs.


The effort, known as the US-Canada Regulatory Cooperation Council (RCC), was started in 2011 in the hopes of increasing regulatory cooperation and eliminating economic barriers to doing business between (and in) the two countries.

The harmonization effort has a special appeal for the life sciences industry, which has been one of the main areas of focus for the RCC. In a July 2012 statement, the US and Canada announced that the US Food and Drug Administration (FDA) and Health Canada (HC) would be working to "better align our regulatory systems, reduce unnecessary duplications and differences and ... better leverage resources."

That effort, both regulators said, would involve a "systemic alignment of regulatory systems, strategies and practices," all in the hopes of eliminating needless red tape.

As Regulatory Focus reported at the time, the effort was to focus on the creation of a harmonized electronic submissions gateway (ESG), a harmonized monograph system for OTC drugs, a mutual reliance on GMP inspections and simultaneous review of veterinary drugs.

Since that announcement, Focus has reported on the progress of several of those initiatives, including the ESG, the simultaneous veterinary review process and the challenges of relying upon other regulators for inspections.

Moving Forward

While the RCC remains a relatively low-key initiative, it's still progressing, the White House and FDA both confirmed this week.

In a blog post on 28 May 2015, the administrator of the White House's Office of Information and Regulatory Affairs (OIRA), Howard Shelanski, said US and Canadian officials have just released new Regulatory Partnership Statements (RPS) and annual work plans meant to advance their respective regulatory cooperation and harmonization efforts.

For example, FDA and Health Canada have released work plans for Pharmaceutical and Biological Products, Over-the-Counter Products, Medical Devices and Veterinary Drugs.

The plans mark the start of work on specific activities—Phase II in the RCC, said Lou Valdez, FDA's associate commissioner for International Programs.

"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," Valdez explained in a posting on FDA's Voice blog.

Among the notable activities set to take place are:

  • coordinate the submission and review of veterinary drugs
  • joint public consultations on International Conference on Harmonisation (ICH) guidelines
  • cooperation on good manufacturing practice drug inspections, especially as it relates to information sharing
  • expanding the common electronic submissions gateway (CESG)
  • undertaking initiatives to "improve regulatory convergence"
  • cooperate on the regulation of sunscreen ingredients
  • collaborating on the development of new device programs under the International Medical Device Regulators Forum (IMDRF)

The RCC's work plans may be found here.

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