关键词: font-size:medium, ">细胞治疗；临床研究；药品监管科学；技术创新

Abstract: Cell therapy， as a cutting-edge hotspot in the biomedical field， its rapid pace of innovation and development not only bears significance for public health but also profoundly impacts national biosafety. Developed countries such as Europe， the United States， and Japan have elevated this to the level of national strategy and established comprehensive drug regulatory systems to consolidate their leading positions in the field of cell therapy. Through rigorous statistical analysis and research， this article comprehensively reviews the current status of cell therapy clinical research in major countries and regions worldwide， tracks the evolution of regulatory systems in Europe， the United States， Japan， and China， and systematically compiles key normative guidelines. Based on these findings， preliminary suggestions for a dual-track regulatory system for cell therapy products and technologies in China are proposed， aiming to provide valuable references for relevant agencies， enterprises， and practitioners.

Key words: font-size:medium, ">Cell therapy； Clinical research； Drug regulatory science；Technological innovation