Canada’s regulatory approach to drugs for rare diseases: apply and register for clinical trials

From Health Canada

Clinical trials: apply and register

Health Canada’s Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) are responsible for reviewing the applications for authorization to sell or import drugs for the purposes of conducting clinical trials in Canada.

Please refer to our detailed guidance on the application process:

• Clinical Trial Applications (CTAs) provides an overview of the requirements for a CTA involving the use of pharmaceutical, biological, and radiopharmaceutical drugs
• Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications provides a manual to all sponsors in, for example, industry, academics and contract research organizations.

Add an additional site to a multi-region clinical trial

A sponsor may add additional sites in a few different ways. If a CTA is already registered at Health Canada, submit a completed Clinical Trial Site Information Form (CTSI Form) for each proposed clinical trial site, if known at the time of the application. For clinical trial site information which becomes available after the time of application, you must provide a completed CTSI Form to the appropriate Directorate before the trial begins at that site.

Under Part C, Division 5 of the Food and Drug Regulations, sponsors submit a Clinical Trial Application to Health Canada for review and authorization regardless of trial authorization in another country. There is no fee to submit a CTA to Health Canada. We will issue review decisions in the form of a No Objection Letter (NOL) within 30 days.

Register a clinical trial

Once a clinical trial has been reviewed by Health Canada, the trial is included in the Clinical Trials Database, a public listing of trials in Canada.

To maximize use of the database and available information, users are advised to link to external resources, including publicly available registries, to obtain further information such as trial objectives and patient eligibility.  Register clinical trials on one of the following publicly accessible registries:

Register a trial with ClinicalTrials.gov, an international registry

Register your clinical study with the Current Controlled Trials International Standard Randomized Controlled Trials Number Register

A Canadian-based registry for cancer trials is also available at Canadian Cancer Trials.

Additionally, the search portal provided by the World Health Organization (WHO) can be used to access a central database that contains information about trials registered in several international registries.