ACCM meeting statement, Meeting 38, 6 November 2025

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.

Overview of the matters referred for advice

The TGA initiated a review of the advertising rules for additional substances and additional vitamin names to be included in the vitamin list in the Therapeutic Goods Regulations 1990. The review aimed to assess any regulatory amendments necessary and determine whether further advertising permissions are warranted. The committee was asked to advise on menaquinone-7 to ensure accurate classification of the substance and to ensure clarity for consumers based on current data. Advice was also sought from the committee regarding certain labelling statements relevant for menaquinone-7.

The TGA initiated an updated safety review of Myristica fragrans (nutmeg/mace) due to concerns regarding compounds associated with abortifacient activity. The review aimed to assess the safety of the ingredient, including its components, based on scientific evidence, traditional use and dosage levels. The committee was asked whether current regulatory settings adequately protect pregnant and lactating women, and if stronger measures, such as contraindication warnings, are warranted in these vulnerable populations.

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.