Abstract: As a new breakthrough treatment, cell therapy has revolutionary significance to the treatment of refractory diseases such as cancer, and has become one of the most potential therapeutic approaches. For many years, Japan has maintained its global leadership in technology development and regulatory policies for cell therapy products, due to its complete legal system and special approval policies. This paper provides a reference for the establishment of safe, standard, stable and traceable management based on a systematic comparison of the laws and regulations over the management of cell therapy products between China and Japan.