Affiliation:
1. Cambridge University, Centre for Economics and Policy, Institute for Manufacturing, Department of Engineering, Trumpington Street, Cambridge CB2 1PZ, UK.
Abstract
The emergence of tissue-engineered products (TEPs) raises a standard question for regulators: is the existing regulatory regime appropriate or is there a case for a new regulatory framework? In the USA, the FDA has developed a risk-based approach to TEPs, whereas in Europe, a common regulatory strategy for these products has not yet been implemented. In order to fill this perceived gap, member states have set up domestic rules, which has led to an unclear and patchy regulatory situation. The Regulation on Advanced Therapy Medicinal Products, voted on by the European Commission in November 2005, has been developed by European Union regulators to provide the necessary framework to regulate TEPs. As the text is still to be discussed and to be passed, many concerns have been raised regarding the appropriateness of the proposed framework.
Subject
Embryology,Biomedical Engineering
Reference24 articles.
1. Directive 93/42/EC of 14 June 1993 concerning medical devices.Official J. L.169(1993).
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