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Determining the Need for an Application

This web page has been created to assist in determining which types of clinical trials involving drugs, natural health products or medical devices require an application to and authorization from Health Canada.

When is an application to Health Canada required for a clinical trial using a Pharmaceutical, Biological and Radiopharmaceutical Drugs; and Natural Health Products?

An application to Health Canada is required to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials.

This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN)/Natural Product Number (NPN)/DIN for Homeopathic Medicine (DIN-HM).

For example, one or more of the following is different:

  • indication(s) and clinical use; 
  • target patient populations(s); 
  • route(s) of administration; or 
  • dosage regimen(s).

When is an application to Health Canada required for a clinical trial using a Medical Device?

To determine when an application to Health Canada is required to conduct clinical trials involving medical devices, refer to the appropriate process flow map:

If you have determined that an application is required, please contact CTS for further guidance.