ACPM meeting statement, Meeting 296, 12-13 February 2014

Role of the Advisory Committee on Prescription Medicines (ACPM) in the TGA's regulatory decision making process

The ACPM 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 ACPM provides advice to the TGA on, amongst other things, matters relating to the inclusion, variation or retention of prescription medicines on the Australian Register of Therapeutic Goods.

The advice provided by the ACPM 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. 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.

Update on matters where the Committee previously provided advice and a TGA decision has been made

The following AusPAR's have been issued and are available on the website: Browse AusPARs by active ingredient

This list is an update from the beginning of 2013.

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought on nineteen applications before the TGA, including: nine applications for new chemical entities; two applications for new combinations of active ingredients, three applications seeking extensions of indications, one application for a new strength, two applications for a new dose form and two applications for a new dosage regimen.

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

Other matters considered

A celebration of 50 years of advice on the safety and efficacy of prescription medicines by the ACPM and its predecessor, the Australian Drug Evaluation Committee (ADEC), was held at Parliament House, hosted by Assistant Minister for Health, Senator the Honourable Fiona Nash.

The ACPM also noted the very impressive booklet produced by the TGA for the occasion.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACPM, please visit the ACPM web page or contact the ACPM Secretary by phone on 02 6232 8252 or email: ACPM.Secretariat@tga.gov.au.