The Regulatory Situation for Clinical Stem Cell Research in China

Abstract

This chapter reviews the regulatory situation for clinical stem cell research in the People’s Republic of China since the early 2000s. The paper is structured in four parts. Part I examines the regulatory conditions for the donation of human gametes and embryos and their use in basic and preclinical research. This involves an overview of China’s regulatory rules for assisted reproductive technologies (ART) and its approach to the governance of human embryonic stem cell (hESC) research. Part II offers a summary of the regulatory and legal instruments that govern clinical trials and other forms of human subjects research in China. These instruments, most of which have been launched in the 1990s and early 2000s, do not specifically address stem cell research, but they influence clinical stem cell research as horizontal regulatory rules. Part III focuses more specifically to the regulation of clinical stem cell research and applications, including the regulation of experimental (for-profit) interventions with stem cells that do not classify as clinical trials or systematic forms of clinical research. This part documents the formation of a regulatory approach for clinical stem cell applications since the mid-2000s, which was still ongoing at the time of writing. The conclusions discuss open questions and the repercussions of China’s regulatory approach for stem cell research for domestic researchers, clinicians, and corporations in China, as well as for international clinical and corporate collaborations.