Complementary medicines reforms
25 March 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:
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.
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.
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.
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.
In further consultation with industry groups, the TGA is developing a comprehensive list of indications that sponsors will be able to use when they list a medicine on the ARTG.
The revised list will be published on the TGA website in early 2014 prior to being added to the listed medicines electronic application portal.
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 Office of Complementary Medicines.
Content last updated: Tuesday, 25 March 2014
Content last reviewed: Tuesday, 25 March 2014
Web page last updated: Monday, 24 March 2014