Phase I-III clinical trials involving natural health products on human subjects must be authorized by Health Canada's Natural Health Products Directorate (NHPD) before commencement of the trial. This process requires the sponsor or a designated representative of the sponsor to submit an application package with detailed information about the proposed trial. This includes:
* This information must be submitted to the NHPD prior to the commencement of the trial if it was not submitted at the time of application for authorization.
Submissions satisfying the NHPD's requirements will be issued a Notice of Authorization to commence the trial. Please note that Health Canada only authorizes clinical trials which take place in Canada and does not have jurisdiction over trials conducted at foreign sites.
The following section provides you with the tools you will need to prepare an application package for a clinical trial involving natural health products on human subjects.
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