A Comparison of the Drug Approval Process in the United States and Canada

The drug approval process is comparative between the United States and Canada. Without the drug approval process, consumers would be experiencing severe health consequences, therefore, the approval process is expensive, time-consuming, and lengthy for pharmaceutical companies to ensure the compound is safe and effective for its intended use.  The electronic databases utilized to recognize applicable published articles from Embase/Ovid and PubMed. The keywords utilized to recognize the pertinent articles were the following: Drug Approval, Drug Development, Food and Drug Administration, United States, Canada, and Pharmaceuticals. The research articles excluded were: non-drug, including vaccines approval process, international regulatory organizations, articles that weren’t relevant to the study, and articles that are not in English language. There was no limit on the date the articles were published. There are more similarities than differences in the drug approval process between Canada and the United States. Both countries contain a regulatory organization (Health Canada; FDA) that review and approve novel drugs to ensure safety and efficacy prior to marketing. Pharmaceutical companies must submit an IND application prior to the inception of clinical trials in humans. Drug approval by FDA is similar to Health Canada, where they develop guidance recommendations to assist pharma companies in complying with regulations. The majority of the published articles focus on the comparison of the drug approval process between the United States and other countries, little-to-no articles discussed the advantages/disadvantages of the drug approval process and how the length of the approval process effects patient population.