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Tissue engineering
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== Regulation == In Europe, regulation is currently split into three areas of regulation: [[medical device]]s, [[medicinal product]]s, and [[biologics]]. Tissue engineering products are often of hybrid nature, as they are often composed of cells and a supporting structure. While some products can be approved as medicinal products, others need to gain approval as medical devices.<ref name="brown2006">{{cite journal | vauthors = Brown N, Faulkner A, Kent J, Michael M | title = Regulating Hybrids: 'Making a Mess' and 'Cleaning Up' in Tissue Engineering and Transpecies Transplantation | journal = Social Theory & Health | volume = 4 | issue = 1 | pages = 1β24 | date = 2006-02-01 | pmid = 32226319 | pmc = 7099299 | doi = 10.1057/palgrave.sth.8700062 }}</ref> Derksen explains in her thesis that tissue engineering researchers are sometimes confronted with regulation that does not fit the characteristics of tissue engineering.<ref>{{cite book| vauthors = Derksen MH |title=Engineering flesh: towards professional responsibility for 'lived bodies' in tissue engineering|date=2008|publisher=Technische Universiteit Eindhoven|isbn=978-90-386-1428-1}}{{page needed|date=July 2021}}</ref> New regulatory regimes have been observed in Europe that tackle these issues.<ref>{{cite journal | vauthors = Kent J, Faulkner A, Geesink I, Fitzpatrick D | title = Towards governance of human tissue engineered technologies in Europe: Framing the case for a new regulatory regime| journal = Technological Forecasting and Social Change | volume = 73| issue = 1| pages = 41β60| series = Technology and Social Risk | date = 2006-01-01| doi = 10.1016/j.techfore.2005.06.006 }}</ref> An explanation for the difficulties in finding regulatory consensus in this matter is given by a survey conducted in the UK.<ref name="brown2006" /> The authors attribute these problems to the close relatedness and overlap with other technologies such as [[xenotransplantation]]. It can therefore not be handled separately by regulatory bodies.<ref name="brown2006" /> Regulation is further complicated by the ethical controversies associated with this and related fields of research (e.g. [[Stem cell controversy|stem cells controversy]], [[ethics of organ transplantation]]). The same survey as mentioned above<ref name="brown2006" /> shows on the example of autologous cartilage transplantation that a specific technology can be regarded as 'pure' or 'polluted' by the same social actor. Two regulatory movements are most relevant to tissue engineering in the [[European Union]]. These are Directive 2004/23/EC on standards of quality and safety for the sourcing and processing of human tissues<ref>{{Citation|title=Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells|date=2004-04-07|url=http://data.europa.eu/eli/dir/2004/23/oj/eng|volume=OJ L|access-date=2020-05-07}}</ref> which was adopted by the European Parliament in 2004 and a proposed Human Tissue-Engineered Products regulation. The latter was developed under the auspices of the European Commission DG Enterprise and presented in Brussels in 2004.<ref>{{cite journal | vauthors = Faulkner A, Kent J, Geesink I, FitzPatrick D | title = Purity and the dangers of regenerative medicine: regulatory innovation of human tissue-engineered technology | journal = Social Science & Medicine | volume = 63 | issue = 9 | pages = 2277β88 | date = November 2006 | pmid = 16905231 | pmc = 7130933 | doi = 10.1016/j.socscimed.2006.06.006 }}</ref>
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