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
The TGA considered previous ACCM advice on the risk of liver injury associated with use of Curcuma specie/curcumin, and green tea extract (Camellia sinensis) that were permitted for use in listed medicines without risk mitigation measures relating to potential liver injury.
ACCM advice was sought for Curcuma species/curcumin at the 30th meeting in November 2022. ACCM advice was sought for green tea extract at the 19th meeting in March 2018, and the matter was also considered in relation to a proposed Schedule 2 entry in the Poisons Standard by the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS 32nd meeting in November 2022). The TGA held a public consultation on these matters in relation to proposed restrictions to be included in the Therapeutic Goods (Permissible Ingredients) Determination to address the risk of liver injury on 14 August 2023. All public consultation submissions were considered and the final decisions were published on 1 December 2023.
Overview of the matters referred for advice
The committee’s advice and comment was sought regarding:
- An updated draft to the Assessed listed medicines evidence guidelines prior to publishing on the TGA website, to address advice provided by ACCM in the 31st and 32nd meeting.
- Proposed modifications to the requirements for indications included in the Therapeutic Goods (Permissible Indications) Determination relating to the respiratory system (such as cough and cold indications), when for use in a listed medicines promoted for children aged <2 years.
- The potential for Garcinia gummi-gutta to cause herb-induced liver injury. The committee was asked to advise if risk mitigation was warranted and possible risk mitigation strategies for when this ingredient, and other related ingredients such as Garcinia quaesita and Hydroxycitrate complex, are used in 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) 6289 2305 or email: accm@health.gov.au.