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Abstract:

© 2015 Elsevier Inc. All rights reserved. With recent developments in the field of tissue engineering (TE), innovative products are seeking access to the market to be applied in patients. Therefore, a framework has to be defined in which tissue-engineered products can prove their safety and effectiveness. For these products, the challenge to live up to the standards of drug development arises, not only with respect to practical implementation but also with respect to legislation and ethics. Within this chapter, an overview is given on the development of the standards for this new class of products and on the current status of regulation and legislation in this rapidly changing field.