A medical system is anticipated, where high-quality medical services are accessible without anxieties whenever we are ill. Innovative cell-based regenerative medical/medicinal products, and tissue-engineered medical products, have been used successfully to overcome certain life-threatening diseases, and there is still a need to design/produce more of these products. We translational researchers in regenerative medicine have been trying to translate our scientific findings from bench to bedside. Advanced therapies with cell-based regenerative medical/medicinal products constitute one of the most complex regulatory areas currently approached by clinical research and development in order to generate novel therapeutic applications for patients with incurable disease. We often lack the multidisciplinary skills needed to overcome intricate and complex regulatory tracks and might feel tired from pursuing clinical realization. Basic researchers and clinicians trying to translate stem cell biology into clinical practice might feel defeated by the endless regulatory requirements that apply. In order to help bridge this gap, in this chapter, we review practical issues that must be confronted in order to move from confidence in mechanism studies in animals into proof of concept studies in human. First, we briefly outline the basic definitions for cell products in the USA, EU and Japan, followed by a focused discussion of the pertinent actions of authorities in Japan.
All Science Journal Classification (ASJC) codes
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Health Policy