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The use of modified unprocessed herbal and biological materials in complementary medicines

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 the use of modified unprocessed herbal and biological materials in complementary medicines.

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

Guidance development

This draft guidance document applies to unprocessed herbal and biological materials whose composition has been chemically modified to the extent that it is significantly different from the original material approved for use in Listed or Registered medicines.

The aim of the document is to provide guidance to sponsors, manufacturers and raw material suppliers regarding the need to undertake a safety assessment to ensure that unprocessed herbal and biological materials, which have a significantly different chemical composition to that presently approved for use in complementary medicines, are safe.

Consultation document

How to access a pdf document

Draft guidance document: The use of modified unprocessed herbal and biological materials in complementary medicines (pdf,217kb)