Phase I-III clinical trials involving natural health products on human subjects must be authorized by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) 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:
- Clinical Trial Application and Attestation Form
- Research Ethics Board (REB) approval(s), if available at the time of application
- The site(s) of the trial identified in the Clinical Trial Site Information Form(s), if the site(s) are known at the time of application*
- The Qualified Investigator(s) identified in the Qualified Investigator Undertaking Form(s), if the qualified investigator is known at the time of application*
- The study protocol
- The Protocol Synopsis and Evaluation Review Template (PCERT)
- Informed Consent document(s)
- The Investigator's Brochure
- Quality (Chemistry & Manufacturing) Information summarized in the Quality Overall Summary - NHP (Phase I/II/III) Template
- Commencement date of the trial
This information must be submitted to the NNHPD prior to the commencement of the trial if it was not submitted at the time of application for authorization.
Submissions satisfying the NNHPD'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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