Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe

Advanced Drug Delivery Reviews 82–83 (2015) 181–191

ABSTRACT: Since the late eighties of last century the high potential of tissue engineered products (TEP)s has been shown for the treatment of various diseases andmany scientific publications appeared in this field. However, only fewproducts reached the market since. Development of TEPs is a promising but owing to its novelty a very challenging task that requires experts in this still developing field aswell as ample financial resources. This paper summarises relevant regulatory challenges during quality, preclinical and clinical development of autologous TEPs in Europe. Selected strategies on how tomanage major issues are presented, togetherwith some examples fromthe development of an autologous TEP for urethroplasty. Considering these aspectsmay help other investigators with potential strategies during the development of novel TEPs.