Open Access Repository

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

Downloads

Downloads per month over past year

Nielsen, J ORCID: 0000-0002-3005-0047, Kaldor, J ORCID: 0000-0002-1299-6023, Irwin, A, Stewart, C and Nicol, D ORCID: 0000-0002-6553-2839 2021 , 'Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia' , Journal of 3D Printing in Medicine , pp. 1-13 , doi: 10.2217/3dp-2021-0011.

[img]
Preview
PDF
146962 - Bespok...pdf | Download (322kB)

| Preview

Abstract

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 Type: Article
Authors/Creators:Nielsen, J and Kaldor, J and Irwin, A and Stewart, C and Nicol, D
Keywords: bioprinting, biomedicine, regulation, law reform
Journal or Publication Title: Journal of 3D Printing in Medicine
Publisher: Future Medicine Ltd.
ISSN: 2059-4755
DOI / ID Number: 10.2217/3dp-2021-0011
Copyright Information:

Copyright 2021 the Authors. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) https://creativecommons.org/licenses/by-nc-nd/4.0/

Related URLs:
Item Statistics: View statistics for this item

Actions (login required)

Item Control Page Item Control Page
TOP