Health Canada Submission Services

CTAs are required to be submitted by the Sponsor to Health Canada for approval for authorization to sell or import a drug for the purposes of a clinical trial (C.05.005). This applies to any drug that is not approved for use in Canada or a drug that is being investigated for an indication that is not listed on the approved product monograph (off-label use). Depending on the product being investigated, the CTA will be reviewed and authorized by either the Pharmaceutical Drugs Directorate (PDD) or Biological and Radiopharmaceutical Drugs Directorate (BRDD).  

Unlike with a drug study, medical device studies do not always require an application.  

ITA is required: 

• For all unlicensed class II, III, and IV medical devices (as defined under the Food and Drugs Act) that will be imported and/or sold in Canada for the purpose of investigational testing involving humans. 

• If the investigator-initiated trial involves an unlicensed device, an ITA would be required. In these cases, the investigator must obtain the cooperation of the manufacturer, who must be the official applicant and signatory for the ITA application. Regulatory correspondence and clinical oversight can be delegated by the manufacturer who is the legal sponsor of the clinical investigation. 

• A licensed device to be used in a manufacturer‐sponsored study intended to generate data to support a new indication for use will require an ITA application. 

• Licensed medical devices used in clinician‐sponsored investigations that are not initiated by the manufacturer and are not intended to generate data to support a licensing application now require an ITA. Clinicians planning to use licensed medical devices in clinical investigations outside the scope of the authorized indications for use are required to involve the manufacturer to submit the ITA. 

The service is available for investigator initiated clinical trials sponsored by the University of Calgary for a fee. 

All documents required for the submissions related to Clinical Trial Applications (CTAs), and Investigational Testing Authorizations (lTAs) can be prepared. This includes amendments, notifications, review responses (screening and information requests), Investigational Status Assessments (ISAs) and pre-submission meeting requests, as required.  

Regulatory submissions can be prepared at the same time as the ethics application, but both must be in place, along with any other operational approvals, prior to beginning enrolment.  

We encourage teams to contact us early in the development of the project so we can provide advice on the required submissions and budget development.