Abstract
Advances in stem cell therapy have led to the surge of regenerative medicine products for treating severe diseases worldwide in the recent years. Stem cells are capable of self-renewal and differentiation, and regenerative medicine products are remarkably complex and varied in their manufacturing processes including methods for cell culture, induction of differentiation and engraftment. The outcomes of the clinical trials of stem cell products also bear uncertainty partly due to the disparities among patients. Therefore it is challenging for the drug administrative agencies to regulate stem cell products. In this article, we review the research progress of the licensed stem cell-based products in the USA, Europe and Japan, along with the regulations and guidance documents of FDA, EMA and PMDA. We also summarize the considerations in evaluating the Chemistry, Manufacture and Control section of stem cell product applications. We hope our effort would contribute to the establishment of science-based regulatory policy in China, and provide the insights for the development and evaluation of regenerative medicine products.
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