【摘要】 美国肿瘤免疫治疗技术的管理由法律进行规范,并由食品药品监督管理局负责统一管理,肿瘤免疫治疗产品的开发由企业主导。目前我国的肿瘤细胞免疫治疗技术被列为第三类医疗技术进行管理,医疗机构承担管理主体责任,在开发上由医院分散式进行。美国经验对我国肿瘤细胞免疫治疗技术管理具有一定的借鉴价值。更多还原

【Abstract】 The administration of tumor immunotherapy technology was standardized by law in America and FDA was responsible for it. The development of tumor immunotherapy products was dominated by the companies. Tumor immunotherapy technology was classified as the type Ⅲ medical technology in China. The medical institutions bear the main responsibility of the management.The development of the technology is dominated by the medical institutions in a scattered situation. The experience of the United States has some reference for the management of tumor cell immunotherapy in China.更多还原