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Implementation path design and policy recommendations for importing unregistered drugs for rare disease through cross-border e-commerce
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Zhao LIU1, 2, Gui-yuan XIANG3, Fan ZHANG1, 2, Jia-yin ZHENG1, 4, 5, Yue-hua LIU1, 2, Kun ZHAO1, 2
Chinese Journal of New Drugs | 2023, 32(5) : 441 - 447
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Chinese Journal of New Drugs | 2023, 32(5): 441-447
Implementation path design and policy recommendations for importing unregistered drugs for rare disease through cross-border e-commerce
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Zhao LIU1, 2, Gui-yuan XIANG3, Fan ZHANG1, 2, Jia-yin ZHENG1, 4, 5, Yue-hua LIU1, 2, Kun ZHAO1, 2
Affiliations
  • 1Vanke School of Public Health, Tsinghua University, Beijing 100084, China
  • 2Institute for Health China, Tsinghua University, Beijing 100084, China
  • 3School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
  • 4China Alliance for Rare Diseases, Beijing 100022, China
  • 5Beijing Society of Rare Diseases Clinical Care and Accessibility, Beijing 100036, China
Published: 2023-03-15
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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.

rare disease drugs  /  unregistered drugs  /  clinically urgent drugs  /  availability  /  cross-border e-commerce
Zhao LIU, Gui-yuan XIANG, Fan ZHANG, Jia-yin ZHENG, Yue-hua LIU, Kun ZHAO. Implementation path design and policy recommendations for importing unregistered drugs for rare disease through cross-border e-commerce[J]. Chinese Journal of New Drugs, 2023 , 32 (5) : 441 -447 .
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  • Online Date：2026-03-05
  • Published：2023-03-15
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History
  • Accepted：2022-07-04
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Affiliations
    1Vanke School of Public Health, Tsinghua University, Beijing 100084, China
    2Institute for Health China, Tsinghua University, Beijing 100084, China
    3School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
    4China Alliance for Rare Diseases, Beijing 100022, China
    5Beijing Society of Rare Diseases Clinical Care and Accessibility, Beijing 100036, China
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多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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