Health Canada has released revised clinical trials guidance for sponsors and trial applications explaining the application requirements for comparative bioavailability trials and filing requirements for the importation of clinical trial supplies.

It also includes clarifications to amendment and notification requirements, study termination and closure criteria, application and review processes, and adverse drug reaction reporting criteria as well as format requirements. The Guidance for Clinical Trial Applications (CTAs) is consistent with the new Common Technical Document (CTD) format.

The revised guidance applies to all sponsors (such as industry, academic, contract research organization) conducting the following clinical trials:

• Trials of a product that is not authorized for sale in Canada including Phases I through III of drug development and comparative bioavailability studies.
• Trials for marketed drugs where the proposed use of the drug is outside the parameters of the Notice of Compliance (NOC) or Drug Identification Number (DIN) application.
• Clinical Trial Application Amendments (CTA-A) [C.05.008] and Notifications (CTA-N) [C.05.007].

The guidance does not apply to Phase IV clinical trials or clinical trials involving medical devices or natural health products except where indicated. 

Health Canada: Revised Clinical Trials Guidance

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