How Clinical Studies are Regulated in Canada

In Canada, Health Canada is responsible for reviewing and authorizing the import/use of natural health products and pharmaceuticals (drugs) for human clinical trials. Trials that are post-market (used according to Health Canada approved label) do not require approval by Health Canada.  All clinical trials, regardless of purpose or investigational product require review and approval by an independent Research Ethics Board (REB).

Health Canada and the Research Ethics Board review the application and decides on whether to accept or reject the application. Trials would be rejected if the use of the natural health product or drug for the purposes of the clinical trial will endanger the health of a clinical trial participant or if the trial is not in the best interests of clinical trial participants, or if the trial is not expected to meet its objectives.

Health Canada will authorize the use of the natural health product or drug in the clinical trial if it meets safety requirements and is expected to meet its objectives. It is important to note that in addition to Health Canada's authorization, a Research Ethics Board also needs to review and approve the trial before the trial is initiated. After clinical trials are ongoing, both Health Canada and the Research Ethics Board monitors the emerging safety data by assessing serious unexpected adverse reactions and other information filed during the study.  A serious unexpected adverse reaction may or may not be related to taking the investigational product.  Health Canada may also carry out clinical trial site inspections to verify if the conduct of a trial meets the requirements of good clinical practices as stipulated in the Regulations.