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ACPM meeting statement, Meeting 306, 2 October 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.
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.
|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.
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