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Equivalence of herbal extracts in complementary medicines

Version 1.0

21 February 2011

About herbal extracts

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.

New information on herbal extracts

TheComplementary Medicines Branch has developed a new guidance document to assist sponsors of medicines that contain herbal substances.

The document entitled "Guidance on Equivalence of Herbal Extracts in Complementary Medicines" Version 1.0 (February 2011) seeks to assist sponsors of medicines containing herbal extracts to determine how and when a herbal extract may be considered 'equivalent' to an ingredient currently included in a therapeutic good and also when it may be used as a substitute without causing the product to be considered a 'separate and distinct good'.

About the regulation of herbal medicines

For more complete information on the use of herbal materials, including the sponsor's or manufacturer's responsibilities under the Therapeutic Goods Act 1989, please refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), in particular Parts III and IV.