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Use of modified unprocessed herbal materials in complementary medicines

Version 1.0

21 February 2011

About herbal ingredients

In Australia, herbal substances are regulated as ingredients in complementary 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 / modification, may affect the safety of the originally approved material.

New information on herbal ingredients

The Complementary Medicines Branch has developed a new guidance document to assist sponsors of medicines containing herbal substances.

The document entitled "Guidance on the use of modified unprocessed herbal materials in Complementary Medicines" Version 1.0 (February 2011) seeks to assist sponsors in identifying situations where the composition of an unprocessed herbal material has been modified to the extent that it is significantly different from the original material approved for use in listed or registered medicines.

About the regulation of herbal medicines

For additional information about herbal materials used in medicines included in the ARTG, please refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), in particular Parts III and IV.