Article(id=1322906895564022204, 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=1617984000000, acceptedDateStr=2021-04-10, onlineDate=1793335182323, onlineDateStr=2026-10-30, pubDate=1636905600000, pubDateStr=2021-11-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335182323, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335182323, creator=13701087609, updateTime=1793335182323, 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=1928, endPage=1933, ext={EN=ArticleExt(id=1322906895735988669, articleId=1322906895564022204, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis on the necessity of international multi-regional clinical trials of imported prophylactic vaccines in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Based on comparison of the marketing time of vaccines approved through multi-regional clinical trials (MRCT) between the United States and China in the past 20 years, representative varieties were selected for case analysis. We systematically analyzed the necessity of conducting international MRCT of vaccines in China, and the system advantages and management strategy of prophylactic vaccine clinical trial, further providing suggestions on feasibility of putting it forward.

, authors=Ze-lin LI¹, Jian-hong YANG², Jiang-ping DONG³, authorsList=Ze-lin LI, Jian-hong YANG, Jiang-ping DONG, authorCompany=null, correspAuthors=Jiang-ping DONG, 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=1322906896159613374, articleId=1322906895564022204, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国开展进口预防性疫苗国际多中心临床试验的必要性, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文通过对比近20年在美国通过国际多中心临床试验（MRCT）路径获批疫苗的上市时间与在中国的上市信息，以选择代表性品种进行案例分析的方式系统地论述了中国开展疫苗国际多中心临床试验必要性，并分析了预防性疫苗临床试验管理策略和制度的优势，进一步提出了在我国落地实施的可行性建议。

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黎泽琳，女，硕士研究生，研究方向：药事管理。E-mail：1161808067@qq.com。

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黎泽琳，女，硕士研究生，研究方向：药事管理。E-mail：1161808067@qq.com。

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(2016-09-08) [2020-06-10]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17_Step2.pdf., articleTitle=null, refAbstract=null), Reference(id=1322906900081287646, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=原国家食品药品监督管理局. 《药品注册管理办法》(局令第28号)[EB/OL]. (2007-07-10) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2077/300629.html., articleTitle=null, refAbstract=null), Reference(id=1322906900144202207, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=国务院. 《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)[EB/OL]. (2015-08-18) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2079/333413.html., articleTitle=null, refAbstract=null), Reference(id=1322906900223893984, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 《关于调整进口药品注册管理有关事项的规定》(第35号令)[EB/OL]. (2017-10-10) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2077/300696.html., articleTitle=null, refAbstract=null), Reference(id=1322906900299391457, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局综合司. 《生物制品注册分类及申报资料要求(征求意见稿)》[EB/OL]. (2020-04-29) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2138/376956.html., articleTitle=null, refAbstract=null), Reference(id=1322906900370694626, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局综合司. 《生物制品注册受理审查指南(第一部分　预防用生物制品)(征求意见稿)》[EB/OL]. (2020-04-29) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2138/376956.html., articleTitle=null, refAbstract=null), Reference(id=1322906900475552227, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 境外已上市境内未上市药品临床技术要求(征求意见稿)[EB/OL]. (2020-04-30) [2020-06-10]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=315054., articleTitle=null, refAbstract=null), Reference(id=1322906900546855396, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Biological Approvals by Year[EB/OL]. (2020-02-19) [2020-06-10]. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year., articleTitle=null, refAbstract=null), Reference(id=1322906900613964261, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 数据查询[EB/OL]. [2020-06-10]. http://app1.nmpa.gov.cn/datasearchcnda/face3/base.jsp?tableId=36&tableName=TABLE36&title=%BD%F8%BF%DA%D2%A9%C6%B7&bcId=152904858822343032639340277073., articleTitle=null, refAbstract=null), Reference(id=1322906900681073126, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 13价肺炎球菌多糖结合疫苗(JXSS1400001)说明书[EB/OL]. (2019-02-11) [2020-06-10]. http://www.cde.org.cn/spxxgs.do?method=show&acceptidCode=ce14deba54ca2374cada2795fa1da9fb., articleTitle=null, refAbstract=null), Reference(id=1322906900777542119, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=EMA. ASSESSMENT REPORT FOR Prevenar 13[EB/OL]. (2009) [2020-06-10]. https://www.ema.europa.eu/en/documents/assessment-report/prevenar-13-epar-public-assessment-report_en.pdf., articleTitle=null, refAbstract=null), Reference(id=1322906900882399720, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Prevnar 13[EB/OL]. (2019-12-11) [2020-06-10]. https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13., articleTitle=null, refAbstract=null), Reference(id=1322906900957897193, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 13价肺炎球菌多糖结合疫苗(JXSS1400001)申请上市技术审评报告[EB/OL]. (2019-02-11) [2020-06-10]. http://www.cde.org.cn/spxxgs.do?method=show&acceptidCode=ce14deba54ca2374cada2795fa1da9fb., articleTitle=null, refAbstract=null), Reference(id=1322906901020811754, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=国家食品药品监督管理总局关于开展药物临床试验数据自查核查工作的公告(2015年第117号)[EB/OL]. (2015-07-22) [2020-06-10]. http://www.nmpa.gov.cn/WS04/CL2138/299803.html., articleTitle=null, refAbstract=null), Reference(id=1322906901087920619, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=EMA. Rotateq: EPAR-Scientific Discussion[EB/OL]. (2006-09-21) [2020-06-10]. https://www.ema.europa.eu/en/documents/scientific-discussion/rotateq-epar-scientific-discussion_en.pdf., articleTitle=null, refAbstract=null), Reference(id=1322906901159223788, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=EMA. Rotateq: EPAR-Procedural steps taken before authorisation[EB/OL]. (2006-09-21) [2020-06-10]. https://www.ema.europa.eu/en/documents/procedural-steps/rotateq-epar-procedural-steps-taken-authorisation_en.pdf., articleTitle=null, refAbstract=null), Reference(id=1322906901255692781, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Clinical Review Part 1-RotaTeq[EB/OL]. (2006-01-30) [2020-06-10]. http://wayback.archive-it.org/7993/20170723031531/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142304.pdf., articleTitle=null, refAbstract=null), Reference(id=1322906901335384558, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 信息公开[EB/OL]. [2020-06-10]. http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3., articleTitle=null, refAbstract=null), Reference(id=1322906901402493423, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局. 药物临床试验登记与信息公示平台[EB/OL]. [2020-06-10]. http://www.chinadrugtrials.org.cn/eap/clinicaltrials.prosearch., articleTitle=null, refAbstract=null), Reference(id=1322906901486379504, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=VICTORIA JG, WANG CL, JONES MS, et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus[J]. J Virol, 2010, 84(12): 6033-6040., articleTitle=null, refAbstract=null), Reference(id=1322906901587042801, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=null, journalName=null, refType=null, unstructuredReference=WILLOUGHBY RE. Use of Rotarix temporarily suspended, no health risks seen[J]. AAP News, 2010, 10: 1542., articleTitle=null, refAbstract=null), Reference(id=1322906901666734578, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Safety Report Updates[EB/OL]. (2020-03-26) [2020-06-10]. https://www.fda.gov/science-research/pediatrics/safety-report-updates., articleTitle=null, refAbstract=null), Reference(id=1322906901767397875, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=null, journalName=null, refType=null, unstructuredReference=医药合伙人. 辉瑞: 沛儿13价肺炎疫苗将重返中国[EB/OL]. (2016-11-04) [2020-06-10]. https://mp.weixin.qq.com/s/nbpucnBoz7ufRNdRLRy7Yw., articleTitle=null, refAbstract=null), Reference(id=1322906901838701044, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=null, journalName=null, refType=null, unstructuredReference=战略支援部队特色医学中心. “沛儿13”真的很神奇吗?[EB/OL]. (2017-07-02) [2020-06-10]. https://mp.weixin.qq.com/s/q3cNzCqs09e-BGW5CV7MfQ., articleTitle=null, refAbstract=null), Reference(id=1322906901905809909, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=null, journalName=null, refType=null, unstructuredReference=袁方. 我国开展国际多中心临床试验的现状及改进措施[J]. 医药导报, 2007, 26(1): 100-102., articleTitle=null, refAbstract=null), Reference(id=1322906901981307382, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=null, journalName=null, refType=null, unstructuredReference=罗建辉, 尹红章. 浅析治疗用生物制品进口注册临床试验与国际多中心临床试验的关系[J]. 中国新药杂志, 2013, 22(13): 1496-1499., articleTitle=null, refAbstract=null), Reference(id=1322906902044221944, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[27], rfOrder=26, authorNames=null, journalName=null, refType=null, unstructuredReference=吴浩飞, 孙亨凡, 孟胜利, 等. 简述疫苗安全性管理[J]. 微生物学免疫学进展, 2013, 41(5): 69-74., articleTitle=null, refAbstract=null), Reference(id=1322906902249742841, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[28], rfOrder=27, authorNames=null, journalName=null, refType=null, unstructuredReference=张晓方, 黄丹, 王翔宇, 等. 国际多中心临床试验监管指南研究报告[J]. 中国新药杂志, 2017, 26(17): 2052-2058., articleTitle=null, refAbstract=null), Reference(id=1322906902329434618, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[29], rfOrder=28, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. REMS Integration Initiative[EB/OL]. (2018-02-02) [2020-11-30]. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/rems-integration-initiative., articleTitle=null, refAbstract=null), Reference(id=1322906904040710651, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906895564022204, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[30], rfOrder=29, authorNames=null, journalName=null, refType=null, unstructuredReference=WHO. Definition and application of terms for vaccine pharmacovigilance[EB/OL]. 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