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ACPM meeting statement, Meeting 307, 3-4 December 2015
Advisory Committee on Prescription Medicines (ACPM)
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.
|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.
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: ACPM.Secretariat@tga.gov.au