ACCM meeting statement, Meeting 15, 6 December 2013

Role of the Advisory Committee on Complementary Medicines (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 nine 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 sometime 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 committee's advice was sought previously in relation to an application for a new registered complementary medicine. Members were informed of the delegate's decision to register the medicine and updated on the inclusion of NeuroTabs (AUST R 209079) on the Australian Register of Therapeutic Goods in May 2013.

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought on four applications before the TGA, all being new substances for use in listed medicines (specifically whether submitted data are sufficient to establish safety of the substances).

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

Other matters considered

Update on the business process review of the Pre-Market Assessment Section, Office of Complementary Medicines (OCM)

Members were provided with an update on the current review of the business processes within the Pre Market Assessment section, OCM.

Updates on regulatory reforms affecting evidence reviews of complementary medicines

Members were provided with an update on the complementary medicines regulatory reforms.

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: Dr Kaylene Raynes by phone on 02 6232 8229 or email: accm@tga.gov.au.