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Human tissue engineered medical products are not regulated on a European level. This means that, to date, various national approaches exist to regulation of Tissue Engineered Products in Europe. In general, diversity exists how these products should be regulated. Some Member States wait for the European Commission to take a position and fill in the gap of regulation. Other countries develop specific regulation on human tissue products, and use elements on tissue banking principles; other countries use the pharmaceutical approach, whereas others use the medical device regulation as a basis.
The industry favors a new regime based on a risk/benefit based approach. The Directive should define essential requirements, and to demonstrate compliance to these requirements, harmonized standards should be used.
Recently, some new initiatives have started, concerning future harmonized European regulation, such as the draft Directive as “Setting high standards of quality and safety for the procurement, testing, processing, storage and distribution of human tissues and cells”, in order to ensure a high level of human health protection. At the same time the European Commission solicited input for a framework to solve free trade amongst Member States.
European regulatory framework, Tissue Engineered Medical Products, Draft Directive DG Sanco, DG Enterprise, EMEA, standards
Vice President Regulatory Affairs/Operations, IsoTis NV, Bilthoven, MB