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ACPM meeting statement, Meeting 288, 1 February 2013

Advisory Committee on Prescription Medicines

1 February 2013

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 eight applications before the TGA, including: three applications for new chemical entities; three applications seeking extensions of indications; and two applications seeking extensions of indications, as well as introducing a new higher strength.

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

The TGA proposes to amend its Guidelines on minimising risk of exposure to Transmissible Spongiform Encephalopathies (TSEs) through medicines and medical devices so as to align with recent changes to the European Pharmacopoeia (Ph. Eur) requirements. The current TGA requirements refer to the Ph. Eur which was recently updated in light of emerging evidence to allow for less stringent requirements.

The revised Ph. Eur requirements reflect the emerging geographical and scientific evidence in relation to TSE risk arising from use of ruminant materials including the decreased incidence of bovine spongiform encephalopathy (BSE) internationally and improved control measures including the testing of cattle for BSE post-mortem and the cessation of ruminant to ruminant feeding.

Revising the TGA TSE requirements to bring them in line with the Ph. Eur will align Australia internationally and help ensure the continued supply of existing therapeutic goods.

Members were asked to provide advice on the proposed amendments, which has now been provided to the TGA for consideration.

Stakeholder engagement

From time to time members of other statutory committees attend a meeting of a TGA statutory advisory committee. In this context, members welcomed the attendance of Dr Hill, Chair of the Pharmaceutical Benefits Advisory Committee (PBAC), for the morning session.

Pharmaceutical Subcommittee (PSC) update

Members noted the Minutes from the 148 Meeting of the PSC, held 26 November 2012, and advice from the 149 Meeting of the PSC, held 21 January 2013.

Next meeting

The next meeting of the ACPM is scheduled for 1 March 2013.

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 8080 or email: