Public Health Agency of Canada
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Vaccine Safety
Frequently Asked Questions
How are vaccines made and licensed in Canada?
Answer: Vaccines for humans are regulated in Canada by the Biologics and Genetic Therapeutics Directorate of Health Canada. Like all medicines, vaccines must undergo several stages of rigorous testing before they are approved for use. The Bureau 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 release 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 Bureau. 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, 7th Edition 2006.
