Article(id=1322906886932144512, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, 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=1613750400000, acceptedDateStr=2021-02-20, onlineDate=1793335180266, onlineDateStr=2026-10-30, pubDate=1636905600000, pubDateStr=2021-11-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335180266, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335180266, creator=13701087609, updateTime=1793335180266, updator=13701087609, issue=Issue{id=1322887411688919265, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='21', pageStart='1921', pageEnd='2016', issueExtLink='null', onlineDate='null', pubDate='1636905600000', pubDateStr='2021-11-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330537006, creator='13701087609', updateTime=1793337443794, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916380919608076, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916380919608077, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1921, endPage=1927, ext={EN=ArticleExt(id=1322906887276077441, articleId=1322906886932144512, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Incentive policy evaluation on orphan drugs in the United States during 1983—2019, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The incentive policy for orphan drugs was evaluated by statistical analysis of the R&D (research and development) and approval of orphan drugs in the United States during 1983—2019. The clinical trials funding, qualification and approval of orphan drugs were statistically analyzed by consulting the FDA official website, clinicaltrial.gov database and related literature. Since the implementation of the Orphan Drug Act in 1983, the United States has established a systematic R&D incentive system for orphan drugs up to now, which has played a huge role in promoting drug R&D and approval.

, authors=Jing-shu YANG^{1, 2, 3}, Dian-zheng YANG^{1, 4}, Yue YANG^{1, 2}, authorsList=Jing-shu YANG, Dian-zheng YANG, Yue YANG, authorCompany=null, correspAuthors=Yue YANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322906887674536322, articleId=1322906886932144512, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=1983—2019年美国孤儿药激励政策评价, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

通过统计分析1983—2019年美国孤儿药研发审批情况，对孤儿药政策的激励效果进行评价。查阅FDA官网和ClinicalTrials.gov数据库及相关文献，统计分析罕见病药物的临床试验资助、资格认定及审批情况。自1983年《孤儿药法案》实施以来，美国建立了较为系统的孤儿药研发激励制度，对药物研发和审批起到巨大推动作用。

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²Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
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²国家药品监督管理局创新药物研究与评价重点实验室，北京　100084
³清华-北大生命科学联合中心，北京　100084, bio={"content":"

杨景舒，女，博士后，主要从事监管科学与药品法律政策研究。E-mail：yjs199307@163.com。

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杨景舒，女，博士后，主要从事监管科学与药品法律政策研究。E-mail：yjs199307@163.com。

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