The use of modified unprocessed herbal and biological materials in complementary medicines
Draft guidance document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 the use of modified unprocessed herbal and biological materials in complementary medicines.
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.
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This draft guidance document applies to unprocessed herbal and biological materials whose composition has been chemically modified to the extent that it is significantly different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.
Deadline for submissions
The deadline for receipt of submissions was close of business Wednesday 21 November 2007.