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Equivalence of herbal extracts

Consultation

7 November 2007

This consultation closed on 21 November 2007.

The Office of Complementary Medicines (OCM), in collaboration with the OCM / Industry Consultation Group (OICG), drafted an adjunct guideline to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM): Guidance on Equivalence of Herbal Extracts.

Submissions on the adequacy or otherwise relevance of the draft document were sought between 7 and 21 November 2007.

Guidance development

This guidance document was developed in recognition of the fact that there are some situations where a sponsor or manufacturer may need to accept extracts with slightly different extractions profiles to those recorded in the Australian Register of Therapeutic Goods (ARTG). An example might be where an extract manufacturer discontinues manufacture of a particular extract.

The use of different solvents, solvent concentrations and extraction methodology may result in preparations with different safety and efficacy profiles compared to the original extract. This draft guidance document describes the circumstances under which herbal extracts may be considered to be 'equivalent', and where a sponsor/manufacturer may substitute an ingredient, without the product becoming a separate and distinct good.

Numerous factors can affect the qualitative and quantitative equivalence of herbal extracts. This guideline emphasises the importance of monitoring all factors that impact on the qualitative and quantitative composition of an extract.

Consultation document

How to access a pdf document

Draft guidance document: Equivalence of herbal extracts (pdf,379kb)