The evolution and current situation of regulations of China’s stem cell industry

Stem cells and regenerative medicine represent one of the most revolutionary frontiers in life sciences, holding transformative potential for treating refractory diseases and improving public health. By 2025, China’s stem cell industry has entered a critical stage of rapid development, driven by strong policy support and increasing research investment. This study systematically reviews the approval status of stem cell products worldwide, alongside the latest advances in clinical trials and investigator-initiated studies in China. To date, more than ten stem cell products have been approved globally, with China approving its first product in 2025. Both the number of clinical trials and investigator-led studies in China rank among the highest worldwide, underscoring the industry’s enormous potential. The paper further provides a comparative analysis of regulatory frameworks across China, the United States, the European Union, and Japan, with particular focus on China’s evolving system of technical guidelines for pharmaceutical, non-clinical, and clinical evaluation. Finally, it proposes forward-looking policy recommendations to promote the sustainable, standardized, and innovation-driven growth of China’s stem cell sector.