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 matters referred for advice
The committee's advice and comment was sought on:
- Aspects of clinical trial data that are critical to make publicly available as part of conducting a clinical trial with regard to the TGA's proposed data protection scheme for assessed listed medicines.
- Whether listed medicines containing higher doses of various forms of magnesium should carry a label warning for potential laxative effects and whether an upper intake limit is necessary.
- Whether Fallopia multiflora has been established as a cause of herb-induced liver injury, and whether there is sufficient evidence to support restrictions to mitigate the risk of liver injury when used in listed medicines.
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 6289 2305 or email accm@health.gov.au.