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Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia


Nielsen, J and Kaldor, J and Irwin, A and Stewart, C and Nicol, D, Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia, Journal of 3D Printing in Medicine, 5, (3) pp. 155-167. ISSN 2059-4755 (2021) [Refereed Article]

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© 2021. The Authors. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License ( which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.

DOI: doi:10.2217/3dp-2021-0011


Like most health-technology innovators, bioprinters are required to traverse a complex landscape featuring varied forms of regulation. This article focuses on one of the most complex aspects: the requirement imposed by regulatory authorities to satisfy them of the safety, efficacy and clinical utility of resultant healthcare products. Satisfaction of such requirements can result in a significant lag between ‘breakthrough’ and clinical delivery. This article examines this aspect of regulation in the USA, Europe and Australia, three leading bioprinting research jurisdictions. In particular, it examines medical devices and medicines categories of regulation, questioning whether a new approach to regulation is required or whether existing product-based regimes are sufficiently adaptive.

Item Details

Item Type:Refereed Article
Keywords:bioprinting, biomedicine, regulation, law reform
Research Division:Law and Legal Studies
Research Group:Law in context
Research Field:Law, science and technology
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Law reform
UTAS Author:Nielsen, J (Associate Professor Jane Nielsen)
UTAS Author:Kaldor, J (Ms Jenny Kaldor)
UTAS Author:Irwin, A (Mr Adam Irwin)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:146962
Year Published:2021
Funding Support:Australian Research Council (DP180101262)
Deposited By:Law
Deposited On:2021-10-05
Last Modified:2022-11-03
Downloads:12 View Download Statistics

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