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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 at the 27th meeting in March 2021 on peripheral neuropathy associated with pyridoxine. Following public consultation on Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22, changes to the requirements for pyridoxine-related ingredients were implemented. These changes stratified the maximum recommended daily dose by age group, reduced listed medicines to provide up to 100 mg/day of pyridoxine, and lowered the threshold for a required warning statement to 10 mg/day. These changes came into effect on 1 March 2022, and included a 12-month transition period until 1 March 2023.
Following an application received by the Scheduling secretariat, the issue was brought to the Advisory Committee on Medicines Scheduling's 46th meeting in November 2024 to discuss the proposed changes to scheduling entry of vitamin B6. A Notice of final decision to amend (or not amend) the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6) has been published on 25 November 2025.
The decision is as follows:
- Oral preparations providing 50 mg or less per recommended daily dose pyridoxine will continue to be available for general retail sale.
- Oral preparations providing more than 50 mg but not more than 200 mg per recommended daily dose pyridoxine will be available over the counter with the advice of a pharmacist.
- Oral preparations providing more than 200 mg per recommended daily dose pyridoxine will continue to require a prescription.
The implementation date of the changes to the Poisons Standard is 1 June 2027.
Following this, the TGA intends to implement other restrictions as recommended by the Delegate in the Interim decision published 26 June 2025. This will most likely implicate changes to the following legislative instruments: Therapeutic Goods (Permissible Ingredients) Determination and Required Advisory Statements for Medicine Labels.
In February 2026, the TGA published an updated safety alert on vitamin B6 to educate consumers and health care professionals of the upcoming changes to vitamin B6 scheduling.
Overview of the matters referred for advice
The TGA initiated a review of the appropriateness of indications for infant colic in listed medicines in the Therapeutic Goods (Permissible Indications) Determination. The review aimed to assess if regulatory amendments are necessary and determine if any mitigation of safety risks is warranted. The committee was asked to advise on whether proposed regulatory changes appropriately mitigate safety risks, and outline any additional reasons or considerations for the TGA. Advice was also sought for alternative views on varying the current indications.
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.