发展监管科学，促进细胞治疗产品和技术应用科学规范发展

细胞治疗（包括干细胞）是目前生物医药领域发展最快、最前沿的领域之一。细胞治疗产品是从实验室培养的干细胞、组织和器官中提取的，被注射到病人体内的生物技术产品。在分析国外情况的基础上，认为加强细胞产品制备和临床应用规范管理是势在必行的大事。提出细胞治疗产品和技术的监管科学的5大要素，据此分析了我国发展的3大短板。最后，为加强法规、政策与科学监管体系建设，促进细胞治疗产业和技术发展，提出发展细胞产品和技术应用的监管科学3点建议：一是发展细胞治疗监管科学的顶层设计的设想；二是在发展政策指导下，细胞产品研发体系和质量标准的原则是产业发展的基础和迫在眉睫的任务的问题；三是降低研发风险，明确细胞产品和治疗技术的主体责任。

Developing regulatory science for advancing normative development of cell therapy products and technologies

Cell therapy (including stem cell therapy) is one of the fastest developing and most advanced fields in biomedicine. Cell therapy products are biotech products that are derived from stem cells, tissues and organs grown in the lab and injected into patients. Based on the analysis of the situation abroad, it is necessary to strengthen the preparation and clinical application of cell products. This paper puts forward five key elements of the regulatory science of cell therapy products and technologies, and analyzes the three shortcomings of China''s development. Finally, in order to strengthen the construction of laws and regulations, policies and scientific supervision system for promoting the development of cell therapy industry and technology, authors put forward three scientific suggestions on the development of cell products and technology applications. First, develop the top-level design idea of cell therapy regulatory science; second, under the guidance of development policies, the principle of cell product research and development system and quality standards is the foundation of industrial development and an urgent task; and third, to reduce the risk of research and development and define the main responsibility of cell products and therapeutic technologies.