Guidance Documents – Clinical trials – Natural health products

This guidance document provides an overview of the definition of a natural health product and of the activities governed by the Natural Health Products Regulations. It is intended to be a first point of reference: it will help readers determine whether a product and the activities related to it are governed by the Natural Health Products Regulations. It also refers to all other applicable policies, guidance documents and other sources of information - the reader will be able to use this document as a starting point.

• Addendum to the Overview Guidance Document
  Date: March 08, 2004
• Clinical Trials for Natural Health Products
  Date: October 30, 2005

This guidance document is designed to assist organizations and individuals in applying for authorization to conduct a clinical trial for a natural health product in Canada.

• Notice to: Stakeholders of Clinical Trials for Natural Health Products
  Date: August 1, 2012
• Notice to: Stakeholders of Clinical Trials for Biologic-Type Natural Health Products
  Date: October 5th, 2012
• Guidance outlining factors considered in determining if a NHP Clinical Trial is to be reviewed by NNHPD (use that is appropriate for self-care) or TPD (not best suited for self-care use)
  Date: August 1, 2012
• Guidance outlining factors considered in determining if a NHP Clinical Trial is to be reviewed by the NNHPD (use that is appropriate for self-care) or by the TPD or the BGTD (not appropriate for self-care use)
  Date: October 5th, 2012