Forward Regulatory Plan 2022-2024: 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)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing regulatory amendments to the Natural Health Products Regulationsand Food and Drug Regulations to ensure that natural health products are labelled in a comparable manner to similar self-care products, such as non-prescription drugs, and would introduce a risk-based approach to regulatory oversight for all self-care products. As the scope of the regulatory proposals is significant, they will be done in phases.

The proposed regulatory amendments would improve the labelling of natural health products (Phase I).

The proposed regulatory amendments would also ensure rules based on level of risk for all self-care products (Phase II and III) via a simplified market access for non-prescription drug products (Phase II) and continuous improvement of the natural health product regulatory framework (Phase III).

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.

Phase I and Phase III would address many recommendations made in the 2021 audit by the Commissioner of the Environment and Sustainable Development.

Additional notes:

To ensure regulatory consistency, some components of this initiative (Phase II, Simplified market access for non-prescription drug products) are intended to be incorporated into the Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs) initiative.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States, European Union and Australia.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to businesses involved in the sale of natural health products and non-prescription drugs in Canada.

It is anticipated that the Phase I proposal would result in Canadians being able to make more informed choices by supporting the safe use of self-care products through improved labelling on natural health products. While businesses may incur costs related to labelling changes, the implementation plan is intended to minimize these impacts to the extent possible.

Phase II would introduce 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. These changes are intended to decrease regulatory burden and costs to businesses, as well as introduce greater efficiencies for businesses.

Phase III would expand the efficiencies and modernization achieved for non-prescription drugs to NHPs, such as a class-based structure for simplified applications and enhanced premarket quality review, annual notification to identify marketed products, site licensing and good manufacturing practices.

Consultations

Stakeholder engagement and consultation has been ongoing since 2016. Health Canada pre-published the Phase I proposed changes in the Canada Gazette, Part l, on June 26, 2021 with a 90-day comment period.

Health Canada plans to publish the Phase I proposed changes in the Canada Gazette, Part II in 2022.

Further information

Related information can be found on:

Self-Care Products

Summary: What We Heard on self-care product regulation

Consultation on the regulation of self-care products

Consulting Consumers on Self-Care Product Labelling: A Report on What We Heard

Consultation: Improved labelling for natural health products: Proposed changes to regulations

Simplified market access to non-prescription drugs (Phase II of the Self-Care Framework)

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 2015

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:

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: