Currently, listed complementary medicines can be included on the ARTG via the Electronic Listing Facility (ELF) with no premarket regulatory oversight by the TGA, provided that certain conditions are met. As part of the listing process, the sponsor is required to specify the indications (specific therapeutic uses) applicable to the medicine by:
selecting one or more indications from a list of standard indications and
recording specific indications in a free text field.
This project seeks to enhance the use of "standard indications" to limit the use of the free-text field.
This project will enhance the use of standard indications for the inclusion of listed complementary medicines on the Australian Register of Therapeutic Goods (ARTG) in order to limit the use of inappropriate indications on the ARTG. The updated processes are intended to improve community confidence in the safety and quality of complementary medicines.
expand the number of standard indications available to sponsors in the ELF through the review and inclusion (where appropriate) of the more common specific indications currently found in the free text field for existing listed complementary medicines
review the standard indications currently available to sponsors in the ELF to remove duplicates
make other minor changes to ELF to improve usability and integrity of the listing process
develop a process for sponsors to request new standard indications.
Legislative amendments are required to progress further stages of the standard indications project such as removing the free text field and requiring sponsors to only use the available standard indications or apply for a new standard indication. Consultation will be conducted as required.
A question and answer page has been developed to assist sponsors of complementary medicines. This page is regularly updated in light of information received by the TGA, and in response to common questions asked by industry sponsors.
Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.