ACCM meeting statement, Meeting 20, 16 November 2018

Role of the ACCM in the TGA's regulatory decision making process

ACCM is a statutory advisory committee established by the Therapeutic Goods Regulations 1990. ACCM provides advice to the TGA on matters relating to the inclusion, variation or retention of complementary medicines on the Australian Register of Therapeutic Goods.

The advice provided by ACCM is an important element in the undertaking of the regulatory functions of the TGA. It forms part of the information that is available to a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. Appropriate consideration will be given to such advice, although it is important to note that neither the TGA nor a TGA delegate is obliged to follow ACCM advice.

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 ACCM advice on the possible association between the use of Camellia sinensis and hepatotoxicity and has published a safety advisory statement on the TGA website regarding the potential risk of harm to the liver. The TGA has also considered ACCM advice in the current version of the 'Assessed listed medicines evidence guidelines (v1.1)'.

Overview of the safety reviews referred for advice

The committee's advice was sought on:

• The safety of boron-containing compounds in children and adolescents.
• The outcomes of the TGA safety review of an excipient ingredient for use in listed medicines.

The advice has now been provided for consideration as part of the TGA's regulatory decision making process.

Other matters considered

The committee's advice and comment was sought on:

• A TGA-proposed risk-based scheme for implementation of changes to permissible ingredients used in listed medicines.
• Aligning the requirements of caffeine in oral listed medicines.
• The comparability of traditional methods of preparation and modern manufacturing processes.

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.