Vines, TimothyFaunce, Thomas2015-12-071320-159Xhttp://hdl.handle.net/1885/21027This article provides a detailed examination of how the safety and cost-effectiveness elements of Australia's drug regulatory system will respond to nanomedicines. The case study investigated involves Abraxane, a newly developed anti-cancer agent. The article concludes by proposing some responses to the challenges which nanomedicines are likely to present to international and domestic agencies. Additionally, it considers whether the recommendation of the Australian Productivity Commission to allow parallel submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Therapeutic Goods Administration (TGA) is appropriate when applied to new nanotherapeutics.Copyright Lawbook Co. This publication is copyright. Other than for the purposes of and subject to the conditions prescribed under the Copyright Act 1968 (Cth), no part of it may in any form or by any means (electronic, mechanical, microcopying, photocopying, recording or otherwise) be reproduced, stored in a retrieval system or transmitted without prior written permission. Enquiries should be addressed to Thomson Reuters (Professional) Australia Limited.Keywords: drug; nanoparticle; article; Australia; chemistry; cost benefit analysis; drug legislation; human; pharmaceutics; Australia; Cost-Benefit Analysis; Humans; Legislation, Drug; Nanoparticles; Pharmaceutical Preparations; Technology, Pharmaceutical20092016-02-24