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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 for pyridoxine at the 27th meeting in March 2021. Changes were implemented to the requirements in the restrictions in the Therapeutic Goods (Permissible Ingredients) Determination on 1 March 2022. An application was received to propose an amendment to the Poisons Standard for human therapeutic preparations containing between 5 mg and 200 mg of pyridoxine, pyridoxal, or pyridoxamine to be included in Pharmacist Only Medicine (Schedule 3) entry. This issue was discussed by the Advisory Committee on Medicines Scheduling's 46th meeting on 7 November 2024. Although the interim decision was scheduled for publication in February 2025, the notice of interim decisions published on 14 March 2025 did not cover interim decisions for pyridoxine, pyridoxal, or pyridoxamine.
ACCM advice was sought for Garcinia gummi-gutta and hepatoxicity 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 associated pregnancy risk. 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 to address liver injury and pregnancy risks on 2 August 2024. This public consultation has closed and the TGA published its final decisions document on 2 December 2024. All changes described in the final decisions document commenced on 1 March 2025, with a 12-month transition period for existing products with exception for changes relating to Australian Approved Names (AANs).
Overview of the matters referred for advice
The committee’s advice and comment were sought regarding:
- Whether probiotic active ingredients should be labelled at the strain level.
- Data requirements for generic iron polymaltose complex (IPC) medicines for registered medicine applications.
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.