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ACPM meeting statement, Meeting 307, 3-4 December 2015

Advisory Committee on Prescription Medicines (ACPM)

1 February 2016

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.

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 295 through to 301, have resulted in the publication of an AusPAR.

Active Application Type
Botulinum toxin - type A Type A - New chemical entity
Propranolol Hydrochloride Type C - Extension of indications
Tocilizumab Type C - Extension of indications
ezetimibe + rosuvastatin (as calcium) Type B - New combination of active ingredients
Peginterferon beta-1a Type A - New chemical entity
Influenza virus haemagglutinin Type A - New chemical entity
Elosulfase alfa Type A - New chemical entity
Ezetimibe / atorvastatin Type B - New combination of active ingredients
Sucroferric oxyhydroxide Type A - New chemical entity
Bevacizumab Type C - Extension of Indications
Omalizumab Type C - Extension of indications
Ponatinib Hydrochloride Type A - New chemical entity
Insulin glargine Type D - Biosimilar medicine
fentanyl (as citrate) Type F - Major variation (dose) and
Type F - Major variation (route of administration)
Dolutegravir (as sodium) / abacavir (as sulfate) / lamivudine Type B - New combination of of previously registered active ingredients
Gadobutrol Type C - Extension of indications
Carglumic acid  Type A - New chemical entity
Eliglustat (as tartrate) Type A - New chemical entity
Ustekinumab Type C - Extension of indications
Sevelamer hydrochloride Type D - New generic medicine
Idelalisib Type A - New chemical entity
Dulaglutide rch Type A - New chemical entity
Tafluprost / timolol (as maleate) Type B - New combination of active ingredients
Aflibercept Type C - Extension of indications

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought on 15 applications before the TGA, including: one for a new chemical entity; one for a new chemical entity in a new combination of active ingredients; four seeking a new biological entity; three seeking extensions of indications; one application seeking a new combination of active ingredients; one seeking a new dosage; four with multiple variation types requiring evaluation.

Sub-committee update Pharmaceutical Subcommittee (PSC)

Members noted the minutes from PSC meeting 164 held on 21 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: