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 on a new guidance document on the quality of listed probiotic medicines at the 23rd and 35th meetings. Following this and extensive public and targeted consultation, the guidance Demonstrating the quality of listed probiotic medicines was published on 15 January 2025.
ACCM advice was sought for Garcinia gummi-gutta and hepatotoxicity at the 33rd meeting in November 2023. At its 34th meeting held in March 2024, the TGA requested advice on herbal ingredients containing apiol and/or myristicin and pregnancy risk. On 2 August 2024, the TGA held a public consultation on Garcinia gummi-gutta, hydroxycitric acid-related ingredients, rue and parsley in relation to proposed restrictions to be included in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination) to address the respective risks. The final decisions were made based on information made available to the TGA. The new requirements have come into effect 1 March 2025 and provide a 12-month transition until 1 March 2026 for any existing affected products to bring their products in compliance.
ACCM advice was sought for green tea extract at the 19th meeting in March 2018. The TGA held a public consultation on these matters in relation to proposed restrictions to be included in the Determination to address the risk of liver injury on 14 August 2023 and the final decisions were published on 1 December 2023. The matter was also considered by the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #32) in November 2022 regarding a proposed Schedule 2 entry to the Poisons Standard. An interim decision was made on 3 February 2023 to not amend the Poisons Standard. On 19 February 2025, the delegate set aside their interim decision and instead arrived at a final decision to amend the current Poisons Standard in relation to Camellia sinensis extract (green tea extract). The decision was made to amend the Poisons Standard to include Camellia sinensis extract (green tea extract) for oral use in Schedule 5. This amendment will be implemented on 1 October 2026.
Overview of the matters referred for advice
The committee’s advice and comment were sought regarding pregnancy risks associated with Myristica fragrans, an herbal ingredient used in listed medicines. The committee was asked to advise if risk mitigation was warranted and possible risk mitigation strategies for the herbal ingredient.
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.