The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was first published in 2001 to provide information on the supply and use of complementary medicines. The TGA is currently reviewing and restructuring the guidelines for ease of use and to align the information with current regulatory requirements. Changes to the original document include formatting, corrections, clarification and consolidation of information. It is important to note that the revision does not introduce any new procedures or procedural changes.
The revised ARGCM has been restructured from 5 parts into 4 parts, with technical information provided in Attachments. The TGA is planning a staged approach to the consultation process for the revised ARGCM. Each draft part will be published separately on the TGA website, with a 4 week consultation period provided for each part. Attachments will be published relevant to each part of the ARGCM.
Following consideration of submissions received, all parts will be consolidated into a final document reflective of the current regulatory requirements for complementary medicines.
Further information on the draft guidelines and the consultation process is available on the TGA website.
By Eoin Hanley
View the 2016 updated guidelines here.