Challenges and Prospects for Cell Therapy Regulation in China

The development of advanced cell-based intervention in China has been rapid, yet it faces a multitude of regulatory challenges. This article comprehensively analyzes the current state and developmental trajectory of the regulatory framework for advanced cell-based intervention in China. The regulation of stem cells and other cell-based interventions in China has undergone multi-phase development, resulting in a relatively well-established regulatory framework that emphasizes pre-clinical research, Good Manufacturing Practices (GMP), and stringent review processes. However, the jurisdiction still confronts several challenges in advanced cell-based intervention regulation. To address these challenges, future regulatory directions in China may include clarifying the drug status of advanced cell-based intervention products, improving technical evaluation systems, establishing risk classification and tiered management systems, strengthening ethical review mechanisms, enhancing the standardization of clinical research, optimizing industrial chain links, and establishing knowledge-sharing platforms.