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利用跨境电商进口未注册罕见病药品的路径设计与政策建议

Implementation path design and policy recommendations for importing unregistered drugs for rare disease through cross-border e-commerce

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【作者】 刘昭; 向贵圆; 张帆; 郑佳音; 刘跃华; 赵琨;

【Author】 LIU Zhao;XIANG Gui-yuan;ZHANG Fan;ZHENG Jia-yin;LIU Yue-hua;ZHAO Kun;Vanke School of Public Health, Tsinghua University;Institute for Health China,Tsinghua University;School of International Pharmaceutical Business, China Pharmaceutical University;China Alliance for Rare Diseases;Beijing Society of Rare Diseases Clinical Care and Accessibility;

【通讯作者】 刘跃华;

【机构】 清华大学万科公共卫生与健康学院; 清华大学健康中国研究院; 中国药科大学国际医药商学院; 中国罕见病联盟; 北京罕见病诊疗与保障学会;

【摘要】 本文基于国内外实践经验,分析了利用跨境电商进口使用未注册罕见病药品的潜在作用和优势,提出了利用跨境电商进口使用未注册罕见病药品的实施方案,包括从患者产生用药需求到最终药品使用与监管全流程的实施路径建议;并探讨了该方案在现实环境中实施时可能存在的挑战与障碍;最后针对利用跨境电商进口和使用未注册罕见病药品的落地实施提出了相应的政策建议。

【Abstract】 Based on domestic and foreign practical experience, this article analyzes the potential effects and advantages of using cross-border e-commerce to import and use unregistered rare disease drugs, and proposes an implementation plan for using cross-border e-commerce to import and use unregistered drugs for rare diseases, including the use of drugs from patients, suggestions for the implementation path of the whole process from demand to final drug use and supervision. We also discuss the possible challenges and obstacles that may exist in the implementation of the program in the real world. Finally, we provide some policy recommendations on using cross-border e-commerce to import and use unregistered drugs for rare diseases.

【基金】 北京罕见病诊疗与保障学会政府购买服务项目:跨境电商进口罕见病药品研究课题
  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2023年05期
  • 【分类号】R95
  • 【下载频次】71
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