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ACPM meeting statement, Meeting 296, 12-13 February 2014

Advisory Committee on Prescription Medicines

19 August 2014

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 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

The following AusPAR's have been issued and are available on the website: Browse AusPARs by active ingredient

This list is an update from the beginning of 2013.

AusPARs issued from the beginning of 2013
Meeting Number Active Sponsor
ACPM 288 Aflibercept rch Sanofi-Aventis Australia Pty
ACPM 288 Apixaban Bristol-Myers Squibb Australia Pty Ltd
ACPM 288 calcipotriol and betamethasone (as dipropionate) LEO Pharma Pty Ltd
ACPM 288 Everolimus Novartis Pharmaceuticals Australia Pty Ltd
ACPM 288 Fidaxomicin Specialised Therapeutics Australia Pty Ltd
ACPM 288 Lixisenatide Sanofi-Aventis Australia Pty Ltd
ACPM 288 Rivaroxaban Bayer Australia Ltd
ACPM 288 Zonisamide SciGen Australia Pty Ltd
ACPM 289 Azacitidine Celgene Pty Ltd
ACPM 289 Eplerenone Pfizer Australia Pty Ltd
ACPM 289 Mycafungin (as sodium) Astellas Pharma Australia Pty Ltd
ACPM 289 Rituximab Roche Products Pty Limited
ACPM 290 Cetuximab Merck Serono Australia Pty Ltd
ACPM 290 Clobazam Sanofi-Aventis Australia Pty Ltd
ACPM 290 Fentanyl citrate Takeda Pharmaceuticals Australia Pty Ltd
ACPM 290 Filgrastim (rbe1) Sandoz Pty Ltd
ACPM 290 Golimumab (rmc1) Janssen-Cilag Pty Ltd
ACPM 290 Interferon beta-1a Merck Serono Australia Pty Ltd
ACPM 290 Linagliptin Boehringer Ingelheim Pty Ltd
ACPM 290 Linagliptin/Metformin HCl Boehringer Ingelheim Pty Ltd
ACPM 290 Pertuzumab (rch1) Roche Products Pty Limited
ACPM 290 Retigabine GlaxoSmithKline Australia Pty Ltd
ACPM 290 Rivaroxaban Bayer Australia Ltd
ACPM 290 Saxagliptin / metformin hydrochloride Bristol-Myers Squibb Australia Pty Ltd
ACPM 290 Vismodegib Roche Products Pty Limited
ACPM 291 Adalimumab (rch) AbbVie Pty Ltd
ACPM 291

Amino acids (L-alanine, L-arginine, L-aspartic acid, L-glutamic acid, glycine, L-histidine, L-isoleucine, L-leucine, L-lysine (as L-lycine acetate), L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine)

Lipids (refined soya oil, refined olive oil)

Glucose (with or without calcium chloride dihydrate)

With and without electrolytes (sodium glycerophosphate hydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate).

Baxter Healthcare Pty Ltd
ACPM 291 Atazanavir Bristol-Myers Squibb Australian Pty Ltd
ACPM 291 Botulinum toxin type A Allergan Australia Pty Ltd
ACPM 291 Collagenase clostridium histolyticum Actelion Pharmaceuticals Australia Pty Ltd
ACPM 291 Dimethyl Fumarate Biogen Idec Australia Pty Ltd
ACPM 291 Fentanyl citrate A. Menarini Australia Pty Ltd
ACPM 291 Ivacaftor Vertex Pharmaceuticals Australia Pty Ltd
ACPM 291 Ivermectin Merck Sharp Dohme (Australia) Pty Ltd
ACPM 291 Lisdexamfetamine dimesilate Shire Australia Pty Limited
ACPM 291 Neisseria meningitidis Group B Factor H Binding Protein fusion protein, Neisseria meningitidis Group B Neisseria Adhesin A protein, Neisseria meningitidis Group B Neisseria Heparin Binding Antigen fusion protein, Neisseria meningitidis serogroup B outer membrane vesicles Novartis Vaccines and Diagnostics Pty Ltd
ACPM 291 Nanoparticle albumin-bound (nab) paclitaxel Abraxis Bioscience Australia Pty Ltd
ACPM 291 Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide Merck Sharp & Dohme (Australia) Pty Limited
ACPM 291 Retapamulin GlaxoSmithKline Australia Pty Ltd
ACPM 291 Romidepsin Celgene Australia Pty Ltd
ACPM 291 Tenofovir disoproxil fumarate Gilead Sciences, Australia & New Zealand
ACPM 292 Alogliptin (as benzoate) Takeda Pharmaceuticals Australia Pty Ltd
ACPM 292 Cobicistat Gilead Sciences Pty Ltd
ACPM 292 Dabrafenib mesilate GlaxoSmithKline Australia Pty Ltd
ACPM 292 Eltrombopag Olamine GlaxoSmithKline Australia Pty Ltd (GSK)
ACPM 292 Elvitegravir Gilead Sciences Pty Ltd
ACPM 292 Purified capsular polysaccharides of Neisseria meningitidis types A, C, W-135 and Y, each conjugated to tetanus toxoid carrier protein GlaxoSmithKline Australia Pty Ltd
ACPM 292 Palonosetron hydrochloride Specialised Therapeutics Australia Pty Ltd

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought on nineteen applications before the TGA, including: nine applications for new chemical entities; two applications for new combinations of active ingredients, three applications seeking extensions of indications, one application for a new strength, two applications for a new dose form and two applications for a new dosage regimen.

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

A celebration of 50 years of advice on the safety and efficacy of prescription medicines by the ACPM and its predecessor, the Australian Drug Evaluation Committee (ADEC), was held at Parliament House, hosted by Assistant Minister for Health, Senator the Honourable Fiona Nash.

The ACPM also noted the very impressive booklet produced by the TGA for the occasion.

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 8252 or email: ACPM.Secretariat@tga.gov.au.