Article(id=1236344966549664685, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1656864000000, acceptedDateStr=2022-07-04, onlineDate=1772697210203, onlineDateStr=2026-03-05, pubDate=1678809600000, pubDateStr=2023-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697210203, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697210203, creator=13701087609, updateTime=1772697210203, updator=13701087609, issue=Issue{id=1236344966058931117, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697210087, creator=13701087609, updateTime=1772697640190, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346770087793082, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346770087793083, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=441, endPage=447, ext={EN=ArticleExt(id=1236344966755185583, articleId=1236344966549664685, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Implementation path design and policy recommendations for importing unregistered drugs for rare disease through cross-border e-commerce, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

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.

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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。

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²Institute for Health China, Tsinghua University, Beijing 100084, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236344967812150232, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236344966549664685, authorId=1236344967665349583, language=CN, stringName=刘昭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹清华大学万科公共卫生与健康学院，北京 100084
²清华大学健康中国研究院，北京 100084, bio={"content":"

刘昭，女，硕士研究生，研究方向：医药卫生政策及药物经济学。E-mail: sarah_zhaoliu@163.com。

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刘昭，女，硕士研究生，研究方向：医药卫生政策及药物经济学。E-mail: sarah_zhaoliu@163.com。

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