ACCM meeting statement, Meeting 12, 7 December 2012

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, 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 to make this information available as soon as reasonably practical after the relevant meeting.

Overview of the therapeutic goods referred for advice

At ACCM 12, the committee's advice was sought on two applications before the TGA: the first being a new substance for use in listed medicines (specifically on the possible therapeutic benefit of the substance if it were to be made available as an active ingredient); and the second, registration of a new medicine (specifically on whether the justification provided by the applicant for lack of compliance with the default standard was appropriate).

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

Other matters considered

The committee was provided with an overview of the reforms underway in relation to the role and outputs of the TGA advisory committees.

Members discussed the ongoing role of the ACCM in the context of the TGA Blueprint reforms and noted the proposed changes to publishing committee outcomes.

The Chair acknowledged the contributions of three members whose terms finish on 31 December 2012.

Next meeting

The next meeting of the ACCM is scheduled for 4 March 2013.

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: Jennifer Burnett by phone on 02 6232 8280 or email: accm@tga.gov.au