Role of the ACCM in the TGA’s regulatory decision making process
The ACCM is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.
The TGA currently has seven statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes. The ACCM provides advice to the TGA on, amongst other things, matters relating to the inclusion, variation or retention of complementary medicines on the Australian Register of Therapeutic Goods.
The advice provided by the ACCM is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.
It should also be noted that information about advice provided by the committee may not become publicly available for some time after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.
Update on matters where the Committee previously provided advice and a TGA decision has been made
ACCM advice was sought at the 30th meeting in November 2022 regarding Withania somnifera (Ashwagandha) and hepatotoxicity. The committee was asked to consider the strength of the relationship between Withania somnifera and liver injury, whether risk mitigation strategies were necessary, and the potential effectiveness of risk mitigation measures.
Following consideration of the issue and ongoing safety monitoring, the TGA published a safety advisory in February 2024 to alert consumers and health professionals to the potential for gastrointestinal adverse effects and very rare cases of liver injury associated with Withania somnifera. In July 2026, the TGA published updated safety communications, including a consumer safety alert and a medicines safety update for health professionals, providing further information on the potential risks and encouraging awareness and reporting of adverse events.
ACCM advice was originally sought regarding Andrographis paniculata and its association with anaphylaxis at the 2nd and 3rd ACCM meetings in 2010. More recently, the TGA sought updated advice from the committee at ACCM 37 as part of a review of the safety of Andrographis paniculata in listed medicines.
Following consideration of the issue and ongoing safety monitoring, the TGA published an updated safety review and supplementary report in April 2026. The TGA also undertook targeted consultation from 8 April to 8 May 2026 on the proposed regulatory changes relating to Andrographis paniculata in listed medicines. The consultation has concluded and the TGA has considered the submissions received. Information regarding the outcome will be published on the High-moderate risk changes website.
Overview of the matters referred for advice
The TGA initiated a review of the suitability of the rectal route of administration for listed medicines. The review followed earlier consideration of routes of administration for listed medicines and sought to assess whether the rectal route remains appropriate within the listed medicines framework. The committee was asked to advise whether restrictions on dosage forms or indications may be warranted to ensure consistency with the low-risk nature of listed medicines.
The advice has now been provided for consideration as part of the TGA's regulatory decision-making process.
Further information
Meeting statements are made publicly available after each meeting.
For further information on the ACCM, please visit the ACCM web page or contact the ACCM Secretary by phone on (02) 5132 3124 or email: accm@health.gov.au.