Article(id=1236731778740843196, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2025.17.003, 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=1737388800000, acceptedDateStr=2025-01-21, onlineDate=1772789433416, onlineDateStr=2026-03-06, pubDate=1757865600000, pubDateStr=2025-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772789433416, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772789433416, creator=13701087609, updateTime=1772789433416, updator=13701087609, issue=Issue{id=1236731777142804746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2025', volume='34', issue='17', pageStart='1793', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=0, createTime=1772789433036, creator=13701087609, updateTime=1772801868692, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236783936152596961, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236783936152596962, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1808, endPage=1813, ext={EN=ArticleExt(id=1236731779403543235, articleId=1236731778740843196, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research and insights into the full lifecycle management of drugs under electronic submission, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: The purpose of this paper is to investigate the current status of the domestic electronic submission system in relation to the comprehensive lifecycle management of drug registration. We aim to analyze the challenges encountered and propose suggestions for improving China's electronic submission system.
Methods: By employing the literature review, this study summarizes and compares the development and current status of the domestic electronic submission system. In light of the actual situation in China, it puts forward targeted suggestions for improvement.
Results and conclusion: In our country, electronic submisisons are categorized into two forms: electronic common technical document （eCTD） submission and Non-eCTD submission. Currently, we are in a transitional phase where both formats coexist. However, during the implementation process, we still face issues such as non-uniform submission format standards and insufficient capacity of provincial bureaus to receive and review eCTDs. In response to these issues, this paper proposes the following specific measures: ①deepening the reform of eCTD and expanding the implementation range of products. ②Strengthening the effective connection of drug management from market launch to post-market. ③Accelerating the standardization of document submission throughout the entire lifecycle of drugs. Through the implementation of these measures, it is expected to expedite the comprehensive electronic process of drug registration and application in our country, thereby enhancing the efficiency and quality of review and approval.
, correspAuthors=Li-juan TIAN, 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, authorCompany=null, fund=null, authors=null, authorsList=Qian-wen YU, Li-juan TIAN), CN=ArticleExt(id=1236731780254986982, articleId=1236731778740843196, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=电子递交下的药品注册全生命周期管理研究, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=
目的: 研究当前国内电子递交制度在药品注册全生命周期管理中的应用现状，分析面临的挑战，提出完善我国电子递交制度的建议。
方法: 采用文献研究和比较研究等方法，回顾并对比分析国内电子递交制度的发展历程及实施现状，结合我国实际情况，提出针对性的改进建议。
结果与结论: 我国的电子递交存在电子通用技术文档（electronic common technical document, eCTD）递交与非eCTD递交2种形式，目前处于两者并行的过渡阶段。但在实施过程中仍面临申请事项递交格式标准不统一、省级药品监管机构接收和审阅eCTD能力不足等问题。针对这些问题，本文提出了以下具体措施：①深化eCTD改革的进程，扩大实施范围。②强化药品从上市前到上市后管理的有效衔接。③加速药品全生命周期文件递交的标准化。通过这些措施的实施，以期加速推进我国药品注册申报全面电子化的进程，从而提升审评审批的效率与质量。
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郁倩雯，女，硕士研究生，主要从事药事法规与药物政策研究。E-mail：981537464@qq.com。
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2023,
33(12): 901-905., articleTitle=药物临床试验源数据管理·广东共识（2023版）, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1236792923963060727, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, xref=null, ext=[AuthorCompanyExt(id=1236792923971449336, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, companyId=1236792923963060727, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1236792923984032249, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, companyId=1236792923963060727, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳 110016)])], figs=[ArticleFig(id=1236792927037485584, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, language=EN, label=null, caption=null, figureFileSmall=0WlppuVDdrxNsZ0N+GSLbQ==, figureFileBig=WnlE9X6JW+C3XMBGtbBS0A==, tableContent=null), ArticleFig(id=1236792927121371666, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, language=CN, label=图1, caption=
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| 阶段 | 递交类型 | 提交途径 | 办理机构 |
|---|
| 临床前 | 临床试验申请（IND） | NMPA网上办事大厅-药品业务系统a | NMPA |
| 临床试验前沟通交流（pre-IND） | CDE“申请人之窗”-沟通交流 | NMPA |
| 临床试验期间 | 研发期间安全性更新报告（DSUR） | CDE“申请人之窗”-研发期间安全性更新 | NMPA |
| 补充申请 | NMPA网上办事大厅-药品业务系统a | NMPA |
| 临床期间沟通交流会议申请（EOP2） | CDE“申请人之窗”-沟通交流 | NMPA |
| 上市前 | 上市许可申请（NDA/BLA） | NMPA网上办事大厅-药品业务系统a | NMPA |
| 上市前沟通交流会议申请（pre-NDA） | CDE“申请人之窗”-沟通交流 | NMPA |
| 上市后 | 备案申请 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 年报 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 再注册 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 上市后研究沟通交流会议申请 | CDE“申请人之窗”-沟通交流 | NMPA |
| 补充申请 | NMPA网上办事大厅-药品业务系统a | NMPA |
), ArticleFig(id=1236792927876346403, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, language=CN, label=表1, caption=
药品注册全生命周期递交类型汇总
, figureFileSmall=null, figureFileBig=null, tableContent=
| 阶段 | 递交类型 | 提交途径 | 办理机构 |
|---|
| 临床前 | 临床试验申请（IND） | NMPA网上办事大厅-药品业务系统a | NMPA |
| 临床试验前沟通交流（pre-IND） | CDE“申请人之窗”-沟通交流 | NMPA |
| 临床试验期间 | 研发期间安全性更新报告（DSUR） | CDE“申请人之窗”-研发期间安全性更新 | NMPA |
| 补充申请 | NMPA网上办事大厅-药品业务系统a | NMPA |
| 临床期间沟通交流会议申请（EOP2） | CDE“申请人之窗”-沟通交流 | NMPA |
| 上市前 | 上市许可申请（NDA/BLA） | NMPA网上办事大厅-药品业务系统a | NMPA |
| 上市前沟通交流会议申请（pre-NDA） | CDE“申请人之窗”-沟通交流 | NMPA |
| 上市后 | 备案申请 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 年报 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 再注册 | NMPA网上办事大厅-药品业务系统 | 省级药品监管机构 |
| 上市后研究沟通交流会议申请 | CDE“申请人之窗”-沟通交流 | NMPA |
| 补充申请 | NMPA网上办事大厅-药品业务系统a | NMPA |
), ArticleFig(id=1236792927972815397, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| 项目 | 非eCTD电子递交 | eCTD递交 |
|---|
| 法规依据 | 《申报资料电子光盘技术要求》（2024年3月1日） | 《电子通用技术文件（eCTD）技术规范》（2021年9月30日）；国家药监局关于扩大药品电子通用技术文档实施范围的公告（2025年第10号） |
| 实施范围 | 国家药监局审评审批药品注册申请以及审评过程中补充资料，以及原料药、药用辅料和药包材登记资料 | 化学药品和生物制品的临床试验申请以及上市许可申请 |
| 生命周期管理 | 无 | 有 |
| 验证项目 | 有（48条） | 有（149条） |
| XML和校验和 | 有（校验算法：SM3国密算法） | 有（校验算法：MD5校验算法） |
), ArticleFig(id=1236792928069284395, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731778740843196, language=CN, label=表2, caption=
非eCTD电子递交与eCTD递交的主要比较
, figureFileSmall=null, figureFileBig=null, tableContent=
| 项目 | 非eCTD电子递交 | eCTD递交 |
|---|
| 法规依据 | 《申报资料电子光盘技术要求》（2024年3月1日） | 《电子通用技术文件（eCTD）技术规范》（2021年9月30日）；国家药监局关于扩大药品电子通用技术文档实施范围的公告（2025年第10号） |
| 实施范围 | 国家药监局审评审批药品注册申请以及审评过程中补充资料，以及原料药、药用辅料和药包材登记资料 | 化学药品和生物制品的临床试验申请以及上市许可申请 |
| 生命周期管理 | 无 | 有 |
| 验证项目 | 有（48条） | 有（149条） |
| XML和校验和 | 有（校验算法：SM3国密算法） | 有（校验算法：MD5校验算法） |
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