A new regulatory regime is being implemented under strict scrutiny for translation of stem cell medical practices since 2015 in China. The new mode of governance is strengthening to curb the marketing of unproven stem cell therapeutic products. This article begins with a brief historical overview of stem cell research and development and then focuses on the policies and country-level guidelines in the past years for stem cell translational research. This study reveals several key observations on the major progress made and the challenges associated with clinical translation of stem cells in China. Given that stem cells or stem cell-based therapeutic products are already considered as biological 'drugs', this study would be conducive to a better understanding of China's approach to stem cell translational research, marketisation and industrialization in progress.
Keywords: Clinical trial; Dual-track regulatory system; Grade IIIA hospital; Stem cell; Translational medicine.
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