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ACPM meeting statement, Meeting 295, 5-6 December 2013
Advisory Committee on Prescription Medicines
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 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.
Overview of the therapeutic goods referred for advice
At this meeting, the committee's advice was sought on fourteen applications before the TGA, including: seven applications for new chemical entities; two applications for a new combination of active ingredients, three applications for extensions of indications; and two applications for a new dosage form.
The committee's advice has now been provided to TGA delegates for consideration as part of the TGA's regulatory decision making process.
Meeting statements are made publicly available after each meeting.