Article(id=1322906825363959875, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, 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=1628438400000, acceptedDateStr=2021-08-09, onlineDate=1793335165587, onlineDateStr=2026-10-30, pubDate=1635523200000, pubDateStr=2021-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335165587, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335165587, creator=13701087609, updateTime=1793335165587, updator=13701087609, issue=Issue{id=1322906824709648449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='20', pageStart='1825', pageEnd='1920', issueExtLink='null', onlineDate='null', pubDate='1635523200000', pubDateStr='2021-10-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793335165428, creator='13701087609', updateTime=1793337419278, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916278284976934, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916278284976935, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1846, endPage=1849, ext={EN=ArticleExt(id=1322906825728864324, articleId=1322906825363959875, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Review and analyses of progress and safety monitoring of clinical trials of COVID-19, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In order to monitor the progress and safety of clinical trials of drugs for COVID-19 (including vaccines), ways to set up efficient working mechanism and working mode for expedited reporting were explored, technical requirements were improved, in depth risk evaluation and management during drug clinical trials were carried out, measures were made to ensure that the applicants implemented risk minimization measures as well as protected the safety of subjects. Meanwhile, by providing comprehensive and reliable real-time research data, the joint prevention and control was promoted as well as research and evaluation linkage, which promoted the overall research and development process of COVID-19 vaccines in China.

, authors=Xiao-jing PEI, Hai-xue WANG, Tao WANG, authorsList=Xiao-jing PEI, Hai-xue WANG, Tao WANG, authorCompany=null, correspAuthors=Tao WANG, 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=1322906825988911173, articleId=1322906825363959875, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新型冠状病毒肺炎临床试验进展及安全性监测工作探讨与分析, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

为了更好地开展新型冠状病毒肺炎（以下简称新冠）应急审评审批药物（包括疫苗）临床试验进展和安全风险监测工作，探索建立了便捷、高效的申请人快速报告机制和工作方式，完善监测技术规范和要求，深入开展临床试验安全风险评估与监管，确保申请人贯彻和实施风险最小化措施，保护受试者安全；同时，通过提供全面、可靠、实时的研究数据，促进联防联控、研审联动，推动了我国新冠疫苗整体研发进程。

, authors=裴小静, 王海学, 王涛, authorsList=裴小静, 王海学, 王涛, authorCompany=null, correspAuthors=王涛, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=0YVXZ+jzmxmI+cPVd/6q2Q==, magXml=ZasolKDCLd/RvosSKIsF6w==, pdfUrl=null, pdf=bW1mryJ4J0blCiHEG7aJ8g==, pdfFileSize=792816, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=3GgFwqu0TUahjd2G1xdhUg==, mapNumber=null, fund=null)}, authors=[Author(id=1322906827876347978, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906825363959875, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=peixj@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322906827964428364, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906825363959875, authorId=1322906827876347978, language=EN, stringName=Xiao-jing PEI, firstName=Xiao-jing, middleName=null, lastName=PEI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100028, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322906828077674573, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906825363959875, authorId=1322906827876347978, language=CN, stringName=裴小静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京　100028, bio={"content":"

裴小静，女，博士，主任药师，主要从事药物临床研究与技术评价及临床试验管理相关工作。联系电话：（010）85243310，E-mail：peixj@cde.org.cn。

"}, bioImg=null, bioContent=

裴小静，女，博士，主任药师，主要从事药物临床研究与技术评价及临床试验管理相关工作。联系电话：（010）85243310，E-mail：peixj@cde.org.cn。

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tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906825363959875, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=国家市场监督管理总局. 药品注册管理办法(国家市场监督管理总局令第27号)[EB/OL]. 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