Herbal substances are regulated as ingredients in medicines. These medicines may be either listed (lower risk) or registered (higher risk) on the Australian Register of Therapeutic Goods (ARTG). The eligibility of specific ingredients, including herbs, for use in listed medicines is determined by the TGA. Herbal ingredients used in registered medicines are evaluated as part of the application for approval of the medicine.
Herbal ingredients differ from pharmaceutical ingredients in that they are complex multi-component substances. It is important to note that significant changes in the chemical composition of herbal substances, as a result of natural variation or selective breeding or modification, may affect the safety of the originally approved material.
The overarching principle for the identification of herbal starting materials is traceability to a primary source or certified herb. Identification testing must discriminate between related species and/or potential adulterants/substitutes that are likely to be present.
More information
- Guidance on equivalence of herbal extracts in complementary medicines
- Guidance on the use of modified unprocessed herbal materials in complementary medicines
- Identification of herbal materials and extracts
- Equivalence of herbal extracts in complementary medicines
- Use of modified unprocessed herbal materials in complementary medicines
- European Union guidelines used by the Office of Complementary Medicines