TGA Guidance on Equivalence of Herbal Extracts for Manufacturers

In Australia, herbal extracts can be approved for use as ingredients in complementary medicines or as complementary medicines themselves. These medicines may be either listed (lower risk) or registered (higher risk) on the Australian Register of Therapeutic Goods. The eligibility of specific ingredients, including herbal extracts, 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. Natural variation is often seen in extracts of herbal ingredients and fluctuations in the availability of extracts may result in differences in the extraction profiles of individual raw material batches of the same herbal ingredient.

To view the Guidance on equivalence of herbal extracts click on the link below.

www.tga.gov.au/industry/cm-herbal-extracts.htm .