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ACPM meeting statement, Meeting 306, 2 October 2015

Advisory Committee on Prescription Medicines (ACPM)

10 November 2015

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 ten 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.

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought on 11 applications before the TGA, including: seven applications for new chemical entities; two seeking extensions of indications; one application seeking a new biosimilar medicine and one application of a new strength and extension of indications.

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

An Australian Public Assessment Report for prescription medicines (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. For more information about AusPARs go here: Australian Public Assessment Reports for prescription medicines (AusPARs).

To browse all AusPARs go here: Browse AusPARs by active ingredient.

The ACPM was advised the following applications, which were previously considered by the committee at meetings 297 and 298, have resulted in the publication of an AusPAR.

Active Application Type
Adalimumab Type C - Extension of Indications
Perampanel (as hemisesquihydrate) Type A - New chemical entity
Suvorexant Type A - New chemical entity
Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Type C - Extension of indications
Radium (233Ra) dichloride Type A - New chemical entity
Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Type C - Extension of Indications
Taliglucerase alfa rpc Type A - New chemical entity
Obinutuzumab Type A - New chemical entity
Eftrenonacog alfa Type A - New chemical entity
Ranibizumab Type C - Extension of Indications
Mifepristone / misprostol Type B - New combination of active ingredients
Empagliflozin Type A - New chemical entity
Aripiprazole Type F - Major variation (strength)
Vedolizumab Type A - New chemical entity
Sofosbuvir Type A - New chemical entity
Simeprevir sodium Type A - New chemical entity
Canakinumab Type C - Extension of indications
Enzalutamide Type A - New chemical entity
Pomalidomide Type A - New chemical entity
Bendamustine hydrochloride Type A - New chemical entity
Brimonidine tartrate Type C - Extension of indications
Umeclidinium bromide Type A - New chemical entity
Dapagliflozin/metformin hydrochloride Type B - New combination of active ingredients
Umeclidinium bromide + vilanterol trifenatate Type A - New chemical entity

Sub-committee update Pharmaceutical Subcommittee (PSC)

Members noted the minutes from PSC meeting 164 held on 22 September 2015.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACPM, please visit: Advisory Committee on Prescription Medicines (ACPM) or contact the ACPM Secretary by phone on (02) 6232 8252 or email: