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Complementary medicines reforms

16 April 2013

The Therapeutic Goods Administration (TGA) has started work on a series of reforms to complementary medicines that seeks to improve community confidence in the safety and quality of these medicines.

This will be achieved by:

• ensuring that the TGA effectively informs the community of its role in providing timely access to the therapeutic goods that Australians need, and that they meet appropriate standards of quality, safety and efficacy
• clarifying requirements for sponsors of complementary medicines
• improving the Australian community's understanding of the TGA's regulatory processes and decisions for complementary medicines
• strengthening the integrity and transparency of the regulatory framework for complementary medicines
• enhancing the complementary medicine regulatory framework to ensure that it remains adaptable to community and industry expectations.

The reforms are part of the TGA reforms: A blueprint for TGA's future ("the Blueprint"), including a number of recommendations from the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines ("the Auditor-General's Report").

The reforms will initially focus on the recommendations from the Auditor-General's report; the recommendations will be implemented through the following projects:

1. Key regulatory guidance materials
2. Standard indications
3. Publishing outcomes of listing compliance reviews
4. Using risk profiles in listing compliance reviews
5. Investigation processes for advertising breaches

Additional recommendations included in the Blueprint also impact upon complementary medicines regulation and will lead to further projects in the future.

Consultation

In considering how to action the Auditor-General's recommendations, the TGA held discussions with an Informal Working Group. This group, consisting of representatives from consumer groups, healthcare professionals and complementary medicine industry associations, provided advice to the TGA on aspects of implementation.

The TGA will conduct consultation with consumers, health professionals and sponsors in relation to aspects of the projects where they have an impact on individuals and/or organisations outside of the TGA.

To ensure that you receive email notification of new consultations, please ensure that you subscribe to email updates.

Reform timeframe and progress

Reform activity	Progress to date	Mar - Jun 2013	Future activity
Key regulatory guidance materials: Evidence Required to Support Indications for listed medicines (excluding sunscreens and disinfectants)	Draft Evidence document published for first consultation 23 April to 25 May 2012. Public submissions published 13 July 2012. Revised evidence document for second consultation 27 August to 22 October 2012. Public submissions published 14 January 2013. Work has been undertaken to develop regulatory amendments to embed the finalised evidence requirements for listed medicines within the legislative framework.	The TGA is currently considering submissions received to the second consultation for the evidence guidelines. After consideration of all submissions, the document will be revised and published.	Once regulatory amendments are implemented the evidence document will take effect and transitional arrangements will be implemented.
Key regulatory guidance materials: Australian Regulatory Guidelines for Complementary Medicines (ARGCM)	ARGCM Part A published for consultation 10 October to 7 November 2012. ARGCM Part B published for consultation 21 January to 17 February 2013.	ARGCM Part C published for consultation 16 April to 14 May 2013. Part D to be released for consultation May/June. Public submissions will be published at the end of the consultation process for all parts of the ARGCM (A, B, C and D). Following consideration of submissions to the various consultations, all ARGCM parts will be consolidated into a final revised document.	The ARGCM will be further reviewed as required when the proposed regulatory reforms for complementary medicine are developed and implemented.
Permitted (coded) indications	Consultation paper on permitted (coded) indications published 14 January 2013 and closes 15 March 2013. Work has been undertaken to develop regulatory amendments to enable the removal of the 'free text' field for indications in listed medicine applications.	Public submissions to the permitted indications consultation paper will be published on the TGA website. After consideration of submissions received, the TGA will finalise the expanded list of permitted indications and develop a mechanism for timely approval of new permitted indications.	Once regulatory amendments have occurred, a phased implementation process will be undertaken.
Update of the current Electronic Listing Facility (ELF)	As an adjunct to the 'permitted coded indications' reforms, work has been undertaken to upgrade the listed medicines application portal (ELF) to improve the useability and 'look and feel' of the system.	Development and testing of the new listed medicines application portal.	Education sessions will be provided for industry prior to launch of new listed medicines application portal.
Publishing outcomes of listing compliance reviews	The listing compliance review framework implemented and published on the TGA website September 2012. Cancellations from the ARTG following compliance review are now routinely published on the TGA website.	Information regarding listed complementary medicines subjected to compliance review will be reported on the TGA website in 2013.
Using risk profiles in complementary medicine reviews	Data collection underway to support the development of risk profiles.	Data collection underway to support the development of risk profiles.	Risk profiles will be developed to assist in prioritising targeted compliance reviews.
Investigation processes for advertising breaches	A standard operating procedure for investigating advertising breaches is in place. A workflow system is being developed to manage advertising complaints and facilitate reporting.	Establish appropriate timeframes for the completion of investigations into advertising breaches.	Provision of reports on progress with investigations and trends in non-compliance.

Contact

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

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