Lost in Translation: China’s Struggle to Develop Appropriate Stem Cell Regulations

Abstract

This paper examines the regulations that govern stem cell use in China. We draw our findings from an analysis of government policies and documents, formal and grey literature, and thirty-nine interviews with Chinese stem cell experts. Although China developed research guidelines for embryonic stem cell research early on, it is still struggling to develop appropriate regulations surrounding the clinical translation of stem cell research. We identify the lessons that can be learned from China’s experiences developing appropriate regulations for their stem cell sector, and show the importance of timely regulation and of regulation for each stage of product development from research through to clinical applications. We discuss the development of appropriate regulation, and the international significance of Chinese stem cell regulations.