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, the International Pharmaceutical Regulators Forum and the International Coalition of Medicines Regulatory Authorities. Regulators will continue to share inspection schedules bilaterally and through the Pharmaceutical Inspection Co-operation Scheme and to promote leveraging of inspection 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 and U.S. Food and Drug Administration will coordinate their respective veterinary drug marketing application submission and review processes to enable simultaneous product reviews. 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.
Crop Protection Products: Health Canada's Pest Management Regulatory Agency and the U.S. Environmental Protection Agency's Office of Pesticide Programs will enhance the existing bilateral system of joint product reviews, including for use expansion submissions, and move towards the establishment of a single application for crop protection products that will be accepted in both countries. This will include coordinated work planning; data sharing; aligning approaches to risk assessment; coordination of submissions; and the alignment of submission requirements. In addition, the Agencies will jointly develop information technology solutions for applicants to facilitate the joint review and processing of pest control product applications submitted to both countries.
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).