Clinical translation

With recent developments in the field of tissue engineering, innovative products are seeking access to the market to be applied in patients. Therefore, a framework must be defined in which tissue-engineered products can prove their safety and efficacy. 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 status of directives and regulation in this rapidly changing field.