Clinical Trial for NHP in Canada
Clinical Trial for NHP in Canada
The Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada must first grant permission for clinical trials using natural health products on humans. This is part of the regulatory oversight the NNHPD provides to ensure that NHPs are safe, effective, and of high quality. In addition, the NNHPD evaluates clinical trial applications to determine if they meet the necessary scientific and ethical standards and monitors the trials to ensure that they are conducted in accordance with the approved protocol and applicable regulations.
The sponsor or a designated representative must submit an application package to conduct Phase I-III clinical trials involving natural health products (NHPs) on human subjects. The Application package contains detailed information about the proposed trial to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). This includes
- The Clinical Trial Application and
- Attestation Form,
- REB approval,
- the study protocol,
- informed consent documents, and
- other relevant information.
- The NNHPD must receive this information before the trial can commence. Once the submission meets all NNHPD requirements, the sponsor will be issued a Notice of Authorization to commence the trial. However, Health Canada only has jurisdiction over clinical trials conducted within Canada and not at foreign sites [1].