Prescription Drug Approval Process: Canada

It is the responsibility of the Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada to ensure all drugs used by the public are safe and effective for specific conditions and of high quality. This responsibility includes ensuring drug companies have tested the drugs they wish to market and the public is protected during each stage of the drug’s development. The TPD is the national authority regulating, evaluating, and monitoring the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. Prior to being given market authorization, a manufacturer must present scientific evidence of a product’s safety, efficacy, and quality as required by the Food and Drugs Act and Regulations.

As reported by Rawson and Kaitin in 2003, ...