Article(id=1292126451822776687, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1765123200000, receivedDateStr=2025-12-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996552663, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996552663, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996552663, creator=13701087609, updateTime=1785996552663, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=274, endPage=278, ext={EN=ArticleExt(id=1292126452028297584, articleId=1292126451822776687, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research status and trends of clinical trials for new drug registration in China, columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze the developmental status and core characteristics of new drug registration clinical trials in China, and to forecast future trends, thereby providing references for the research and development (R&D) layout of the pharmaceutical industry and the optimization of relevant policies.
Methods Based on public data from the Annual Drug Evaluation Report and the Annual Report on the Progress of Clinical Trials for New Drug Registration in China published by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) from 2020 to 2024, a comprehensive analysis was conducted on the growth in the number of clinical trials, drug types, distribution of indications, implementation efficiency, and progress in key areas.
Results In 2024, the total number of registered clinical trials reached 4 900, a record high. The proportion of Phase Ⅱ and Phase Ⅲ trials increased steadily, indicating continuous optimization of R&D efficiency. Clinical trials for chemical drugs and biological products were concentrated in the anti-tumor field, while trials for traditional Chinese medicine focused primarily on respiratory and digestive system diseases. Trials in key areas such as cell and gene therapy, drugs for rare diseases, and pediatric medications showed significant growth.
Conclusion New drug clinical trials in China are demonstrating trends towards greater efficiency, innovation, and internationalization. Future efforts should focus on policy guidance and technological innovation to further optimize resource allocation, overcome homogeneous competition, and promote the high-quality development of the pharmaceutical industry.
, authors=Xiao-han WANG, Zhu-xing YAO, Wen-dong LIU, Xian SU, Yang-ping HU, Hai-xue WANG, authorsList=Xiao-han WANG, Zhu-xing YAO, Wen-dong LIU, Xian SU, Yang-ping HU, Hai-xue WANG, authorCompany=null, correspAuthors=Hai-xue 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=1292126452263178609, articleId=1292126451822776687, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=中国新药注册临床试验的研究现状和趋势分析, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=
目的 分析中国新药注册临床试验的发展现状与核心特征，展望未来趋势，为医药产业的研发布局与相关政策优化提供参考。
方法 基于国家药品监督管理局药品审评中心（CDE）2020至2024年发布的《年度药品审评报告》及《中国新药注册临床试验进展年度报告》等公开数据，对临床试验的数量增长、药物类型、适应症分布、实施效率及重点领域进展进行综合分析。
结果 2024年临床试验登记总量达4 900项，创历史新高；Ⅱ期和Ⅲ期试验占比稳步提升，显示研发效率持续优化。化学药品与生物制品试验集中于抗肿瘤领域，中药临床试验则主要聚焦于呼吸系统和消化系统疾病。细胞与基因治疗、罕见病用药、儿童用药等重点领域增长显著。
结论 中国新药临床试验呈现高效、创新、国际化的发展趋势。未来需通过政策引导与技术创新，优化资源布局、突破同质化竞争，以推动医药产业的高质量发展。
, authors=王晓晗, 姚珠星, 刘文东, 苏娴, 胡洋平, 王海学, authorsList=王晓晗, 姚珠星, 刘文东, 苏娴, 胡洋平, 王海学, authorCompany=null, correspAuthors=王海学, authorNote=
王晓晗（1995-），女，主管药师，主要从事药物临床试验安全风险管理与药物警戒工作
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