创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

雕钰惟, 梁毅. 日本细胞治疗产品管理及对我国的启示[J]. 药学进展, 2019, 43(12): 908-913.
引用本文: 雕钰惟, 梁毅. 日本细胞治疗产品管理及对我国的启示[J]. 药学进展, 2019, 43(12): 908-913.
DIAO Yuwei, LIANG Yi. Management of Cell Therapy Products in Japan and Its Implications for China[J]. Progress in Pharmaceutical Sciences, 2019, 43(12): 908-913.
Citation: DIAO Yuwei, LIANG Yi. Management of Cell Therapy Products in Japan and Its Implications for China[J]. Progress in Pharmaceutical Sciences, 2019, 43(12): 908-913.

日本细胞治疗产品管理及对我国的启示

Management of Cell Therapy Products in Japan and Its Implications for China

  • 摘要: 细胞治疗作为一种突破性的新型治疗方式,对癌症等重大难治性疾病的治疗具有革命性的意义,目前已成为最具潜力的治疗途径之一。多年来,日本一直在细胞治疗产品的技术研发和监管政策方面保持全球领先地位,得益于其完整的法律体系与特殊的审批政策。系统对比中日两国在细胞治疗产品临床管理方面的相关法规、部门责任以及审批路径,为确立安全、规范、稳定、可追溯的细胞治疗产品管理提供借鉴与参考。

     

    Abstract: As a new breakthrough treatment, cell therapy has revolutionary significance to the treatment of refractory diseases such as cancer, and has become one of the most potential therapeutic approaches. For many years, Japan has maintained its global leadership in technology development and regulatory policies for cell therapy products, due to its complete legal system and special approval policies. This paper provides a reference for the establishment of safe, standard, stable and traceable management based on a systematic comparison of the laws and regulations over the management of cell therapy products between China and Japan.

     

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