Journal
JOURNAL OF THE ROYAL SOCIETY INTERFACE
Volume 7, Issue -, Pages S789-S795Publisher
ROYAL SOC
DOI: 10.1098/rsif.2010.0442.focus
Keywords
biomaterials; healthcare; regulation
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Whenever new technology emerges it brings with it concerns and uncertainties about whether or how it will need to be regulated, particularly when it is applied to human healthcare. Drawing on the recent history in the European Union (EU) of the regulation of cell-based medicinal products, and in particular tissue-engineered products, this paper explores the myths that persist around their regulation and speculates on whether the existing regulatory landscape in the EU is flexible enough to incorporate nanotechnology and other new technologies into healthcare products. By untangling these myths a number of clear conclusions are revealed that, when considered in the context of risk benefit, make it clear that what hinders the uptake of new technology is not regulatory process but basic science.
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