Complementary medicines reforms
12 November 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:
- Key regulatory guidance materials
- Standard indications
- Publishing outcomes of listing compliance reviews
- Using risk profiles in listing compliance reviews
- 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.
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.
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|Reform activity||Progress||Future activity|
|Update key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines||
The TGA has completed two rounds of public consultation.
The TGA hosted Road Shows in Melbourne, Sydney and Brisbane in July and August 2013.
The TGA will conduct further workshops with industry organisations in November and December 2013.
The updated evidence document will be published in early 2014.
In the future, the evidence document will be revised as required.
|Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)||
The TGA has completed a four-stage public consultation over a period of nine months for the revised ARGCM. The final consultation ended in July 2013.
The TGA is finalising the ARGCM taking into consideration comments received throughout the consultation period.
The TGA will publish the consultation submissions and a TGA response to those submissions on the TGA website in December 2013. The revised ARGCM will also be published at this time.
In the future, the ARGCM will be reviewed as required.
|Permitted (coded) indications project||
The TGA completed a public consultation on the permitted (coded) indications project on 15 March 2013.
The TGA published the 27 consultation submissions on the TGA website 19 June 2013.
A revised list of proposed indications will be published on the TGA website in early 2014.
The new indications will be added to the listed medicines electronic application portal.
|Update of the listed medicines electronic application portal||
The TGA hosted Road Shows in Melbourne, Sydney and Brisbane in July and August 2013 to assist with the introduction of the new portal.
|The new permitted indications list will be added to the listed medicines application portal.|
|Publishing outcomes of listing compliance reviews||
The listing compliance review framework was implemented and published in September 2012.
In October 2012, the TGA began publishing information on products which have been cancelled from the ARTG as a result of a compliance review.
Information regarding listed complementary medicines that have been cancelled from the ARTG as a result of compliance reviews will continue to be reported on TGA website: Complementary medicines: Cancellations from the ARTG following compliance review.
Next year, information on the outcomes of all compliance reviews will be published on the TGA website.
|Enhancing post-market monitoring||Data that is collected from listing compliance reviews performed by the TGA are being used to develop risk profiles.||The TGA will continue to collect data from listing compliance reviews to prioritise reviews based on risk profiling.|
|Investigation processes for advertising breaches||
A standard operating procedure for investigating advertising breaches is now being used by the TGA.
An internal workflow is being developed to manage advertising complaints and facilitate reporting.
Appropriate timeframes for the completion of investigations into advertising breaches are being refined by the TGA.
|The TGA will finalise 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 Office of Complementary Medicines.
Content last updated: Tuesday, 12 November 2013
Content last reviewed: Tuesday, 12 November 2013
Web page last updated: Tuesday, 12 November 2013