Canada-United States Regulatory Cooperation Council (RCC)
The Canada-United States (U.S.) Regulatory Cooperation Council (RCC) provides regulators from Canada and the U.S. the opportunity to work together to reduce unnecessary regulatory burden on stakeholders, while continuing to protect the health and safety of citizens and the environment.
The RCC provides a forum for stakeholders, including industry, consumers, and non-government organizations, to discuss regulatory barriers and identify opportunities for regulatory cooperation. The following technical work plans are based on ongoing discussions between Canadian and U.S. regulators and were informed through stakeholder participation.
Department to Department Commitments and Work Plans
Canadian Department: Health Canada – Health Products and Food Branch
U.S. Department/Agency: Food and Drug Administration
Regulatory Cooperation Statement - Medical Devices: Health Canada and the U.S. Food and Drug Administration (FDA) 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). The IMDRF aims to accelerate international medical device regulatory harmonization and convergence for regulators and stakeholders worldwide. Building upon existing regulatory harmonization initiatives, Health Canada and the FDA will work towards the development of the Medical Device Single Review Program (MDSRP) to improve patient access to medical devices, support innovation, and strengthen standards development. The MDSRP development process, pilot, and program launch will take place over two years from 2019 to 2021.
Regulatory Cooperation Statement - Veterinary Drugs: Health Canada and the U.S. Food and Drug Administration will continue to coordinate their respective submission and review processes for veterinary drug applications to enable simultaneous product reviews. Further work in this area will also explore the expansion of Simultaneous Review to generic animal drug applications.
Regulatory Cooperation Statement - Pharmaceutical and Biological Products: Health Canada and the 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 Harmonization 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.
Regulatory Cooperation Statement - Over-the-Counter Products: Health Canada and the 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.
- 2016/2017 Work Plan: Over-the-Counter Products
Canadian Department: Health Canada – Healthy Environments and Consumer Safety Branch
U.S. Department/Agency: Department of Labor – Occupational Safety and Health Administration
Regulatory Cooperation Statement - Globally Harmonized System for Classification and Labelling of Chemicals (Workplace Hazards): Health Canada and the U.S. Department of Labor will continue to collaborate on implementing updates to the Globally Harmonized System of Classification and Labelling (GHS) in their respective jurisdictions.
The objective of this collaboration is to ensure that the Canadian and U.S. requirements for hazard classification and communication remain aligned to the greatest extent possible with each other and with the GHS as it is updated. Where possible, the objective is to have one label and one safety data sheet (SDS) that would be acceptable in both countries, while respecting the legislative and regulatory requirements of each country and without reducing the level of safety or protection to workers.
This work is in line with the 2018 Memorandum of Understanding (MOU) between Health Canada and the U.S. Department of Labor.
Canadian Department: Health Canada - Pest Management Regulatory Agency
U.S. Department/Agency: Environmental Protection Agency - Office of Pesticides Program
Regulatory Cooperation Statement - Pesticides:Health Canada and the U.S. Environmental Protection Agency are working together to foster an atmosphere of ongoing cooperation, collaboration, and regular communication to better align regulatory approaches in the following areas:
- Alignment of Pesticide Residue Chemistry
- Joint Review (JR) Process Improvements (New Chemicals/Uses)
- Pesticide Re-evaluation and Post-Market Joint Reviews
- Pollinator Protection and Neonicotinoid Pesticides
- Pest Control Emerging Technologies
- New Approach Methodologies (NAMs)
- Emerging Pesticide Issues
Canadian Departments: Health Canada and Environment and Climate Change Canada
U.S. Department/Agency: Environmental Protection Agency
Regulatory Cooperation Statement - Chemicals Management: Health Canada, Environment and Climate Change 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).
- 2016/2017 Work Plan: Chemicals Management
Previous RCC Partnership Statements
- Regulatory Partnership Statement of Health Canada and the United States Occupational Safety and Health Administration on Workplace Chemicals
- Regulatory Partnership Statement of Health Canada's Pest Management Regulatory Agency and the United States Environmental Protection Agency Office of Pesticide Programs
- Regulatory Partnership Statement of Health Canada and the United States Food and Drug Administration
- Regulatory Partnership Statement of Environment Canada and the United States Environmental Protection Agency
For More Information
- Government-Wide Forward Regulatory Plans
- Cabinet Directive on Regulatory Management
- Red Tape Reduction Action Plan
- Canada-United States Regulatory Cooperation Council
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