146962 - bespoke regulation.pdf (355.61 kB)
Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia
journal contributionposted on 2023-05-21, 02:59 authored by Jane NielsenJane Nielsen, Jenny KaldorJenny Kaldor, Adam Irwin, Stewart, C, Dianne NicolDianne Nicol
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.
Australian Research Council
Publication titleJournal of 3D Printing in Medicine
Department/SchoolFaculty of Law
PublisherFuture Medicine Ltd.
Place of publicationUK
Rights statement© 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 (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.