Forward Regulatory Plan 2023-2025: Regulations Amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework)
Title of Regulatory Initiative
Regulations Amending the Natural Health Products Regulations and the Food and Drug Regulations (Self-Care Framework)
Health Canada is proposing regulatory amendments to the Natural Health Products Regulations and Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for self-care products. As the scope of the regulatory proposals is significant, the proposed amendments will be advanced in separate regulatory proposals.
Future proposed amendments would modernize the Natural Health Products Regulations through the creation of a risk-based categorization structure and enhanced pre-market quality review. Amendments would also introduce an annual notification to identify marketed products, revisions to strengthen the requirements for good manufacturing practices, and a risk-based site licensing program. These amendments would also address recommendations made in the 2021 audit by the Commissioner of the Environment and Sustainable Development of the natural health products program.
Future proposed amendments to the Food and Drug Regulations would develop expedited pathways for lower-risk non-prescription drug products, including a class-based licensing system, appropriate pharmacovigilance requirements and establishment licensing that is commensurate with the risk of these products.
This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.
This regulatory initiative is associated with Health Canada's Stock Review Plan.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
This regulatory proposal would better align Canada’s requirements with those of other jurisdictions such as the United States, European Union and Australia.
Potential impacts on people in Canada, including businesses
The proposed amendments would apply to businesses involved in the sale of natural health products and non-prescription drugs in Canada.
Proposed amendments to the Natural Health Products Regulations are anticipated to strengthen oversight and provide people in Canada with greater assurance of the quality of marketed natural health products.
Proposed amendments to the Food and Drug Regulations are anticipated to decrease regulatory burden and costs to businesses, as well as introduce greater efficiencies for businesses.
Stakeholder engagement and consultation has been ongoing since 2016.
Health Canada will continue to engage stakeholders in 2023.
Health Canada published the regulatory amendments to improve the labeling of natural health products in the Canada Gazette, Part II on July 6, 2022.
Related information can be found on:
Additional information can be requested from the departmental contact.
Departmental contact information
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
Consult Health Canada's acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada's implementation of government-wide regulatory management initiatives
Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:
To learn about upcoming or ongoing consultations on proposed federal regulations, visit:
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