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ACPM meeting statement, Meeting 296, 12-13 February 2014
Advisory Committee on Prescription Medicines
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.
|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|
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.
Meeting statements are made publicly available after each meeting.