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Frequently Asked Questions

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How are vaccines made and licensed in Canada?

Like all medicines, vaccines must undergo several stages of rigorous testing before they are approved for use. Health Canada is the regulatory authority in Canada responsible for working to maximize the quality, safety, and efficacy of all biologic drugs, including vaccines for human use.

The Biologics and Genetic Therapies Directorate (BGTD), within the Health Products and Food Branch (HPFB) of Health Canada, is responsible for Canada's vaccines regulatory program in collaboration with the HPFB Inspectorate and the Marketed Health Products Directorate.

BGTD also supervises all aspects of vaccine production by the manufacturers. Before any vaccine is licensed and approved for use in Canada, the factory where it is manufactured must be inspected to ensure that all stages of production meet the requirements for safety, sterility and quality control.

Before released by the manufacturer, each batch of vaccine is tested for safety and quality under guidelines specified by the Biologics and Radiopharmaceuticals Evaluation Centre. Most safety tests are carried out by both the manufacturer and, independently, by the laboratory of the BGTD.

Once vaccines are in use, Canada has several systems in place to ensure that they are carefully monitored and that any problems are dealt with quickly. These systems are described in the section "Adverse Events" in the Canadian Immunization Guide, Evergreen Edition.

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