A new priority pathway for biologicals in Australia: Contextualising and evaluating the proposed reforms
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Open Access
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ArticleAbstract
This article examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed ...
See moreThis article examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.
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See moreThis article examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.
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Date
2022Source title
Journal of Law and MedicineVolume
29Issue
3Publisher
Thomson ReutersFunding information
APP2007623
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Copyright All Rights ReservedRights statement
This article was published by Thomson Reuters in the Journal of Law and Medicine and should be cited as Rudge, C., Attinger, S., Kerridge, I., Lipworth, W., & Stewart, C. (2022). A new priority pathway for biologicals in Australia: Contextualising and evaluating the proposed reforms. Journal of Law and Medicine, 29(3), 677–699. For all subscription inquiries please phone, from Australia: 1300 304 195, from Overseas: +61 2 8587 7980 or online at legal.thomsonreuters.com.au/search. The official PDF version of this article can also be purchased separately from Thomson Reuters at http://sites.thomsonreuters.com.au/journals/subscribe-or-purchase. 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. PO Box 3502, Rozelle NSW 2039. legal.thomsonreuters.com.auFaculty/School
The University of Sydney Law SchoolShare