Institutional/Investigator-initiated CTA Requirements

The Food and Drug Regulations provide authority to the Health Products and Food Branch (HPFB) of Health Canada to regulate the sale of drugs for the purposes of use in human clinical trials.  Division 5 of the Regulations defines specific Clinical Trial Application (CTA) requirements and prescribes a 30-day default review period for these applications. Amendments to Division 5 were announced in June 2001 and took effect September 1, 2001.

Sponsors, meaning an individual, corporate body, institution or organization that conducts a clinical trial must file applications to conduct clinical trials in Phases I through III of drug development.  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) application, if one or more of the following is different:

1. Indication(s) and clinical use
2. Target patient population(s)
3. Route(s) of administration
4. Dosage regimen(s)

A CTA must be filed prior to the initiation of a clinical trial in Canada.  HPFB must review the application and notify the sponsor within 30 days if the application is found to be deficient or else the sponsor may proceed.

Institutional or Investigator-initiated CTAs must also comply with the same regulatory requirements that apply to sponsor-initiated CTAs, with some modification as outlined in the Guidance for Clinical Trial Sponsors document referenced below.

Staff questions concerning the preparation of a CTA may be addressed to Gita Sobhi, HHS Manager of Pharmacy Research Support Services, 905.521.2100 x 73447.