Regulatory Process in Canada

Canada can help research sponsors save money and time. In 2002, the country’s regulatory agency, Health Canada, undertook an ambitious program to improve review turnaround times and enhance communication with the industry. Since then, the review times for clinical trial applications have been cut in half, dropping from 60 to 30 days.

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To conduct a clinical trial in Canada, research sponsors must submit an application to Health Canada prior to the initiation of the trial. (If desired, sponsors may request a consultation meeting with Health Canada before submitting their application.)

Once the application is submitted, Health Canada’s Health Products and Food Branch reviews the information to ensure the trial is properly designed and that participants will not be exposed to undue risk.

Overview of the clinical trial application process.

Processing time for clinical trial applications by location

processing time

Source: Clinipace Worldwide, “The Joys and Woes of Clinical Trial Start-Up: A Global Perspective,” as reproduced by Clinical Trials Ontario, 2014.


Canada’s clinical trial requirements are set out in the Food and Drugs Act and Regulations. For medical devices, investigational testing requirements are set out in the Medical Devices Regulations.

Approval stages for new drugs and medical devices

approval stages

Source: Health Canada, Access to Therapeutic Products: The Regulatory Process in Canada, 2006. Retrieved from

If the results of the clinical trial indicate that a new drug has potential therapeutic value that outweighs the risks associated with its proposed use (e.g., adverse effects or toxicity), the manufacturer may seek authorization to sell the product in Canada by filing a New Drug Submission (NDS) with Health Canada. In the case of new brand-name products, these submissions contain detailed and extensive scientific information about the product’s safety, efficacy, and quality. They also include the results of both pre-clinical and clinical studies, details on drug production, packaging, and labelling; and information about the drug’s therapeutic value, conditions for use, and side effects.

After the New Drug Submission is received, Health Canada does the following:

  • performs a thorough review of the submitted information, sometimes using external consultants and advisory committees
  • evaluates the safety, efficacy, and quality data to assess the potential benefits and risks of the drug
  • reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g., the label and product brochure).

If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN). This indicates the drug’s official approval, which permits the sponsor to market the drug in Canada.

More information about how drugs are reviewed in Canada

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