Health Canada (HC) is the health authority (HA) responsible for market authorization of drugs in Canada. The mandate of the Health Products and Food Branch (HPFB) of HC is to manage the health-related risks and benefits of health products and food through the administration and enforcement of the Food and Drug Act and its Regulations. HPFB activities are carried out through the Directorates and Offices.

All drugs must undergo a rigorous review and fully satisfy all scientific requirements of the Food and Drug Act and its Regulations prior to their entry to the Canadian market.

Health Canada examines the scientific data from preclinical and clinical trials, how the drug is produced, packaged and labelled, and thereby determining the drug’s safety, efficacy and quality. The data is provided to HC in the form of a New Drug Submission (NDS), or supplement to a NDS (SNDS) for follow on indications.