Australian regulatory guidelines for complementary medicines (ARGCM)
Version 5.1 August 2014
The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.
If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant (for a list of consultants, refer to the Complementary Medicines Australia, the Australian Self Medication Industry and the Association of Therapeutic Goods Consultants).
- Part A: General guidance on complementary medicine regulation in Australia
- Part B: Listed complementary medicines
- Part C: New complementary medicine substance evaluation
- Part D: Registered complementary medicines
- Additional guidance material
Refer to the TGA acronyms & glossary for terms, definitions & acronyms used in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
|Version||Description of change||Author||Effective date|
|V5.0||ARGCM V5 is a revision and restructure of ARGCM V4.2. Changes to the original document include formatting, corrections and clarification of information. While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice.||Office of Complementary Medicines||November 2013|
Correction of hyperlinks throughout document.
Update references to Evidence guidelines for listed medicines.
Update information on Approved terminology for medicines.
Update information on Complementary medicine interface issues. Include link to Food Medicine Interface Tool on the TGA website.
Instructions for searching the ingredient database via the TGA eBusiness Services (eBS) website.
Clarification of information on indications for listed medicines.
Insertion of reference to ARGCM Part D Table 6 in relation to changes in excipient ingredients for listed medicines.
Under 'Manufacturing changes', minor modification to MUS code (GMP clearance number update). Deletion of MST code (Change to manufacturing site and/or process of sterile product).
About the Therapeutic Goods Administration (TGA)
- The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices.
- The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
- To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>.
© Commonwealth of Australia 2014
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