🪴 Pathway for Licensing Natural Health Products Used as Traditional Medicines
This guidance document from Health Canada explains the regulatory pathway for licensing natural health products (NHPs) that are used as traditional medicines in Canada. It outlines evidence requirements for safety, efficacy and traditional use to support product licence applications under the Natural Health Products Regulations.
📌 Purpose and Scope
The guidance aims to help industry and practitioners understand the type and amount of evidence needed to support traditional medicine claims for natural health products. It applies to products intended to be marketed as traditional medicines, not to those making modern health claims or products under specific exemptions.
📍 Natural Health Products and Traditional Medicines
A Natural Health Product (NHP) includes substances or combinations listed under Schedule 1 of the Natural Health Products Regulations, such as herbal medicines, vitamins, minerals, homeopathic and traditional medicines. Traditional medicines are defined as those based on historical knowledge, beliefs and practices of a particular culture, used for maintaining health or addressing physical and mental conditions.
🧪 Evidence Requirements for Licensing
✔ Safety and Efficacy Evidence
Applicants must provide evidence demonstrating that the product is safe and efficacious when used under its recommended conditions. This includes supporting information on dosage, duration, route of administration, and risk information. Historical evidence of use is often acceptable for traditional products if it supports both safety and efficacy.
✔ Demonstrating a History of Traditional Use
A long history of use can be shown through references describing the medicinal ingredient(s) used within a recognized traditional medicine system (e.g., Traditional Chinese Medicine, Ayurvedic medicine) over at least two generations. Monographs, pharmacopoeias and reputable cultural compilations can also be submitted as evidence.
📑 Traditional Medicines vs Modern Claims
Traditional medicines are assessed using evidence based on historical practice and cultural context, whereas products with modern health claims require contemporary scientific evidence such as clinical or peer-reviewed studies. If a product’s recommended use does not align with traditional medicine contexts, modern evidence pathways may be necessary.
📋 Application and Assessment Process
To obtain a product licence in Canada, applicants must submit a complete application to the Natural and Non-prescription Health Products Directorate (NNHPD), including required evidence for safety, efficacy and traditional use. The NNHPD reviews the materials to assess whether the benefits outweigh any potential risks.
📈 Key Considerations for Traditional Medicines
- Consistency with traditional practice: Evidence must reflect the way the ingredients are traditionally used, including preparation methods and dosage.
- Multiple ingredients: If a product contains multiple traditional ingredients, each should be justified logically within one system of medicine.
- Documentation quality: References should be authoritative, such as monographs from recognized pharmacopoeias.
📌 Practical Tips for Applicants
- Use clear traditional references that align with a recognized system of medicine.
- Ensure safety information, including cautions and contraindications, is supported by evidence.
- Provide complete documentation on recommended use conditions, including dose and duration.
