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Title: Taking temperature: a review of European Union regulation in nanomedicine
Authors: Van Calster, Geert ×
D'Silva, Joel #
Issue Date: 2009
Publisher: Kluwer Academic Publishers
Series Title: European Journal of Health Law vol:16 issue:3 pages:249-269
Abstract: Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.
ISSN: 0929-0273
VABB publication type: VABB-1
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Research Unit International and Foreign Law - miscellaneous
Institute for Environmental and Energy Law
× corresponding author
# (joint) last author

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