Equivalence of herbal extracts
Draft guidance document
7 November 2007
This consultation closed on 21 November 2007.
Call for comment
The Office of Complementary Medicines (OCM), in collaboration with the OCM / Industry Consultation Group (OICG), has drafted an adjunct guideline to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) <http://www.tga.gov.au/docs/html/argcm.htm>: Guidance on Equivalence of Herbal Extracts.
Submissions on the adequacy or otherwise relevance of the draft document are being sought before finalisation of the guideline. Submissions may be sent by post and/or email and, where appropriate, should specify the page, paragraph and line to which the comment refers. In addition, stakeholders are encouraged to provide other comments that will assist in the finalisation and implementation of this document.
Draft guidance document: Equivalence of herbal extracts (pdf,379kb)
Guidance development
This guidance document has been 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 This draft guidance document describes the circumstances under which herbal extracts may be considered to be 'equivalent', and where a sponsor/manufacturer may substitute an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.
Deadline for submissions
The deadline for receipt of submissions was close of business Wednesday 21 November 2007.