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Complementary medicines reforms

25 June 2014

Over the past two years, the Therapeutic Goods Administration (TGA) has undertaken a series of reforms to complementary medicines to improve community confidence in the safety and quality of these medicines.

The reforms are part of the TGA reforms: A blueprint for TGA's future and address the recommendations of the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines.

The key reform activities include:

Update to the Australian Regulatory Guidelines for Complementary Medicines

Following public consultations on parts A, B, C and D (refer to Complementary medicines (closed consultations & reviews), the final revised Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was published on 13 December 2013. The ARGCM provides information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.

Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines

Following two consultations on the Evidence required to support indications for listed medicines (excluding sunscreens and disinfectants), 26 July 2012 and the second, Evidence required to support indications for listed medicines (excluding sunscreens and disinfectants), 27 August 2012 and workshops with industry, the revised Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines were published on 25 March 2014.

These guidelines provide information for sponsors and applicants on the type of evidence that is required to support indications for listed complementary medicines; and help sponsors understand their regulatory obligations in relation to holding evidence to support indications that are made for those medicines.

Update to the listed medicines electronic application portal

The online listed medicines application and submission portal was updated to improve its useability. The eBusiness Services portal was launched in August 2013, together with a Listed medicines application and submission user guide.

Enhancing post-market monitoring

Data that is collected from listing compliance reviews performed by the TGA will be used to develop risk profiles to prioritise future compliance review activity.

Publishing outcomes of listing compliance reviews

Information regarding listed complementary medicines that have been cancelled from the ARTG as a result of compliance reviews are now reported on the TGA website: Complementary medicines: Cancellations from the ARTG following compliance review.

In late 2014, information on the outcomes of all compliance reviews will be published on the TGA website.

Permitted (coded) indications project

In 2013, the TGA undertook an initial public consultation on the permitted (coded) indications project. The 27 consultation submissions and the TGA's response are available on the TGA website.

As of June 2014, the proposed legislative amendments associated with the permitted indications reform were put on hold pending broader consideration of the Government's deregulatory agenda in the context of the TGA.

In the interim, the TGA will proceed with the aspects of the reform that can be implemented within the existing regulatory framework. In particular, the updating of the indications list in the listed medicines application portal will be progressed notwithstanding any delay to legislative amendments for the broader permitted indications reform.

The TGA will continue to work with industry to ensure that an updated, comprehensive list of indications meets the needs of complementary medicine industry and improves compliance with the regulatory framework. Once finalised, the TGA will proceed to make the list available through the online listed medicines application portal.

Investigation processes for advertising breaches

A standard operating procedure for investigating advertising breaches is now being used by the TGA. The TGA is currently finalising a workflow system for complaints handling and to facilitate reporting of non-compliance with advertising requirements.


For further information about the complementary medicines regulatory reforms, contact the Complementary Medicines Branch.