On February 4, 2011 Prime Minister Stephen Harper and United States (U.S.) President Barack Obama announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) to better align the two countries' regulatory approaches, where possible.
This announcement was followed by the release of the initial RCC Joint Action Plan which came to a close in March 2014 and included many successes including the implementation of the Common Electronic Submission Gateway, a streamlined process of joint reviews for pesticides with minor use, and greater alignment between Canada and the U.S under the Globally Harmonized System of Classification and Labelling of Chemicals.
On August 29, 2014, a second phase of regulatory cooperation was initiated with the public launch of the RCC Joint Forward Plan. The Joint Forward Plan seeks to make regulatory cooperation a routine, ingrained practice between Canadian and U.S. regulatory authorities.
Two key deliverables of the Join Forward Plan include the development of Regulatory Partnership Statements that outline the framework for how cooperative activities will be managed between agencies, and the development of work plans that support the Department to Department commitments included in the Joint Forward Plan.
In meeting its commitments set out in the Joint Forward Plan, Health Canada, with U.S. counterparts, has developed the following Regulatory Partnership Statements and work plans.
Pharmaceutical and Biological Products: Health Canada and U.S. Food and Drug Administration will continue to work closely together to harmonize and align their pre and post-marketing surveillance requirements and standards (including pharmacovigilance issues) through the work of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the International Pharmaceutical Regulators Forum. They will also continue to share inspection schedules through the Pharmaceutical Inspection Co-operation Scheme and to promote leveraging of inspectional resources to maximize inspection coverage. Regulators will also continue to expand the Common Electronic Submission Gateway for the biological and pharmaceutical industry, where appropriate.
Over-the-Counter Products: Health Canada and U.S. Food and Drug Administration will coordinate and adjust their respective over-the-counter (OTC) monographs development processes for OTC drugs to reduce the regulatory burden on stakeholders.
Medical Devices: Health Canada and U.S. Food and Drug Administration will continue to work closely together on pre and post market regulatory convergence topics, including in particular, through the International Medical Devices Regulators Forum (IMDRF). IMDRF aims to accelerate international medical device regulatory harmonization and convergence for regulators and stakeholders worldwide.
Veterinary Drugs: Health Canada’s Veterinary Drugs Directorate and the U.S. Food and Drug Administration’s Center for Veterinary Medicine will coordinate their respective submission and review processes for veterinary drug applications to enable simultaneous product reviews with a view to simultaneous product availability. They will coordinate standards development as appropriate and assessment activities pertaining to the pre-market evaluation of veterinary drugs. Further work in this area will also explore the availability of electronic templates that could be used to submit veterinary drug applications.
Workplace Chemicals: Health Canada and the U.S. Department of Labor will work together to coordinate the adoption of future updates of the Globally Harmonized System for Classification and Labelling of Workplace Chemicals (GHS) to facilitate common approaches and synchronized implementation in Canada and the United States. This includes developing a mechanism to maintain alignment as the system is updated and modernized or new requirements or standards are put in place, exploring innovative methods to jointly engage stakeholders as well as enhanced collaboration on common interpretation and guidance materials.
Pesticides: The US Environmental Protection Agency's (US EPA) Office of Pesticide Programs (OPP) and Health Canada's Pest Management Regulatory Agency (PMRA) are working together to:
Chemicals Management: Environment Canada, Health Canada and the U.S. Environmental Protection Agency will collaborate in efforts to align chemical regulatory processes, specifically through the development of common approaches to address emerging risk issues and jointly considering how the use of novel data can inform the assessment of chemicals. Further, they will collaborate in efforts to develop common approaches for regulatory reporting requirements for new uses of chemical substances (Significant New Activity provisions/Significant New Use Rules).