Abstract:Stem cells represent a very important part of modern regenerative medicine. From perspectives of clinical translation， the pathway of the development of stem cells in forms of either “medicine” or “clinical technology” is full of various challenges. All these challenges， in terms of the “Law-Regulation-Guidance” regulatory system， can be associated with different layers of the system， which are the layers of Law， Regulation or Guidance. Since the buildup of the “Law-Regulation-Guidance” system for biomedical products has been generally lagged behind in China， various challenges in all three layers of the system remain to be urgently addressed. It is thus understandable that no current regulatory system can be directly fit into the need of stem cell development in China. In addition， the general lack of the sense of observing the law in the entire society makes the situation even more difficult. Through engaging in an academic discussion on the “Law-Regulation-Guidance” system for biomedical products in general，this paper attempts to clarify the regulatory features of the existing problems encountered in clinical development of stem cells according to the three-layer regulatory system with a hope of helping build up the regulation-driven thinking during the product development and the associated regulation， and moreover， establish the regulatory system dedicated to the regulation of stem cell products in China.