Policies and Regulations

Health Canada establishes science-based policies and regulations to minimize the risk to Canadians of biotechnology-based health products while ensuring their quality and effectiveness.

Regulations

Biotechnology-based drugs are subject to the Food and Drug Regulations. Medical devices that involve biotechnology are subject to the Medical Devices Regulations.

The regulations for biotechnology-based drugs and medical devices set out strict requirements regarding:

• Quality, Safety and Effectiveness;
• Labelling (for example, ingredients and directions for use, including dosage);
• Good Manufacturing Practices (for example, quality controls);
• Mandatory reporting of problems and serious adverse reactions;
• Clinical trials;
• Licensing of establishments that import, store, manufacture, or distribute drugs or medical devices;
• Issuance of Drug identification numbers (DINs) and / or Notices of Compliance (NOCs); and
• Licensing of medical devices.

According to the regulations, Health Canada market authorization is required in order to import or sell drugs or medical devices in this country. Manufacturers must prove they have met all requirements as set out in the Food and Drug Regulations. They must also provide scientific evidence on the products' safety and effectiveness when used as directed.

Health Canada reviews the evidence and does a thorough assessment of safety, quality and efficacy of each product before deciding whether it can be granted a Notice of Compliance or Device Licence. Read more about the Review and Evaluation Process as it relates to the various biotechnology-based health products.

New Regulatory Initiatives

Health Canada also works to ensure that regulations for biotechnology-based health products keep pace with today's rapid developments in science and technology.

Health Canada has proposed a new regulatory framework for the Safety of Cells, Tissues and Organs for Transplantation.

Policies

The following are examples of Health Canada's policies to support the safety, efficacy and quality of health products, including biotechnology-based products:

• Guidance for Clinical Trial Sponsor: Clinical Trial Applications; and
• Compliance and Enforcement Policy. This policy explains the steps we take to make sure that industry complies with regulations for health products.

Other Information

Read our Fact Sheet on Xenotransplantation for more on the benefits, risks and status of xenotransplantation in Canada.