Stem cells hold tremendous promise for regenerative medicine. With continuous development in this field, stem cell medicines are starting to enter mainstream drug development. Due to their distinct and complex characteristics, which are significantly different from those of traditional medicine, new opportunities and challenges are arising in stem cell medicine development. Therefore, to facilitate the clinical translation of stem cells and adapt to scientific and technological progress, it is important to formulate and update regulatory policies and standards that are specifically appropriate for cell therapy. In this section, we discuss the regulatory policies on stem cell medicine and drug standards in China, and review the ongoing development of international and Chinese standards related to stem cell medicine. Finally, we discuss the framework for establishing a standard system for stem cell medicine in the future.