Health Canada发布健康产品合规与执法政策POL-0001，2026年9月15日生效并替代第9版

• Overview
• Roles and responsibilities
• Guiding principles
• Compliance and enforcement actions and tools
• Glossary
• References

This policy comes into effect on September 15, 2026. It replaces version 9.

On this page

• Disclaimer
• Purpose
• Scope
• Context

Disclaimer

This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

Purpose

This policy describes Health Canada's national compliance and enforcement approach for health products regulated under the Food and Drugs Act (the Act) and its regulations. It aligns with Health Canada's Compliance and Enforcement Policy Framework, which outlines Health Canada's general approach to compliance and enforcement and identifies fundamental principles and decision factors that guide departmental activities.

Scope

This policy applies to Health Canada's compliance and enforcement activities conducted in relation to health products and activities regulated under the Act and its regulations.

The regulated health products within the scope of this policy include:

• biocides
• blood and blood components for transfusion or for the use in the manufacture of a drug for human use
• cells, tissues and organs for transplantation
• human drugs
• medical devices
• natural health products
• veterinary drugs and veterinary health products

The regulated activities within the scope of this policy include:

• advertising
• selling
• manufacturing/fabricating
• packaging/labelling
• testing
• importing
• distributing
• wholesaling
• conducting clinical trials

As the regulatory landscape adapts to innovation, and as new health products and activities become regulated under the Act, this policy will apply to the oversight of these products and activities.

Context

Health Canada administers legislation whose purpose is to protect the health and safety of people in Canada. The Regulatory Operations and Enforcement Branch (ROEB) is the dedicated compliance and enforcement branch within Health Canada. ROEB's mission is to lead compliance and enforcement activities along with complementary scientific initiatives to inform and protect people in Canada from health and safety risks, including those associated with health products.

Today's regulatory environment is intricate and shaped by highly complex and fragile global supply chains, a rapid pace of innovation, changing consumer behaviours and increased domestic and global e-commerce. Consumers are increasingly exposed to the sale of unauthorized or otherwise non-compliant health products, particularly online. They are also exposed to a growing amount of misleading or non-scientific information while making critical health choices.

Risks to health and safety can come from different sources, such as:

• through the sale of an unauthorized health product
• by not meeting labelling and advertising requirements
• by using ingredients that are contaminated or of substandard quality
• by not following quality and safety requirements when manufacturing a product

The lack of access to, or a shortage of a health product, may also present a risk to the health and safety of people in Canada.

We recognize that a risk may not pose harm to all consumers equally and may result in varying adverse health outcomes for different populations. Therefore, ROEB's compliance and enforcement activities take sex, gender and diversity considerations into account.

Refer to Sex- and Gender-Based Analysis Plus in Action at Health Canada for more information on how we integrate sex, gender and diversity considerations into our programs and services.

The complex environment in which ROEB regulates health products and activities impacts how we carry out our work. It is increasingly important to have a strong and dynamic compliance and enforcement function to help protect the health and safety of people in Canada. Health Canada is adapting to this changing digital and regulatory landscape through modern legislation, digital tools, strong border oversight and international cooperation.