Article(id=1322181181613916960, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, 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=1620835200000, acceptedDateStr=2021-05-13, onlineDate=1793162158635, onlineDateStr=2026-10-28, pubDate=1627574400000, pubDateStr=2021-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793162158635, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793162158635, creator=13701087609, updateTime=1793162158635, updator=13701087609, issue=Issue{id=1322181102488375822, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='14', pageStart='1249', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1627574400000', pubDateStr='2021-07-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793162139770, creator='13701087609', updateTime=1793162209831, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181396408419308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181396408419309, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1260, endPage=1265, ext={EN=ArticleExt(id=1322181181827826465, articleId=1322181181613916960, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Overall analysis of new Chinese herbal drug approval and registration in recent years, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The paper analyzed the status quo of new Chinese herbal drug (NCHD) approval and registration in recent years, discussed the characteristics and existing problems of NCHD, then provided feasible suggestions. From 2012 to 2019, the number of NCHD approval showed a downward trend, but the approval rate increased. From 2015 to 2020, the number of NCHD registration decreased significantly, the number of category 6 new drugs had the largest number of registration, and there was no registration of category 2 and new drugs of category 4. The regional distribution of declaration units was obvious, the top 5 regions accounting for 48% of the total number of applications. The new drugs were mainly oral preparations, and the treatment field was concentrated in major common diseases. The sources of NCHD were mainly clinical prescriptions and scientific research achievements of scientific research institutions. In general, the quality of NCHD application has been improved, but the amount is at low tide. All stakeholders need to take multiple measures to promote the research and development of NCHD.

, authors=Feng HONG1, Dan-dan CHU1, Hui-fang XU1, Lin MA1, Hao LI1, Wei LIU1, 2, authorsList=Feng HONG, Dan-dan CHU, Hui-fang XU, Lin MA, Hao LI, Wei LIU, authorCompany=null, correspAuthors=Wei LIU, 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=1322181182075290402, articleId=1322181181613916960, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=近年我国中药新药审批及注册申请现状分析, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

通过收集2012—2019年中药新药审批完成及2015—2020年中药新药注册申请的数据,从中药新药审批及申报数量、注册分类、申报主体、剂型分布、治疗领域及来源等多方面进行分类整理,多维度分析其现状,探讨中药新药申报的特点及现存问题,并提供相应建议。2012—2019年,中药新药审批完成数量呈下降趋势,但批准率有所提升;2015—2020年中药新药注册申请数量出现明显下降,6类新药注册申请数量最多,未见2类、4类新药注册申请;申报单位地区分布差异明显,前5名地区申报数量占比高达48%;新药剂型以普通口服制剂为主,治疗领域集中在重大常见疾病领域;新药来源主要为临床验方及科研院校科研成果。总体而言,我国中药新药申报质量有所提升,但申报量处于低谷期,各相关方需多措并举,合力推动中药新药研发。

, authors=洪峰1, 褚丹丹1, 徐慧芳1, 马琳1, 李浩1, 刘伟1, 2, authorsList=洪峰, 褚丹丹, 徐慧芳, 马琳, 李浩, 刘伟, authorCompany=null, correspAuthors=刘伟, authorNote=

洪峰,男,硕士研究生,主要从事医药知识产权保护与成果转化研究。E-mail:。

, correspAuthorsNote=
刘伟,男,副教授,硕士生导师,主要从事医药知识产权保护与成果转化教学及研究工作。E-mail:。
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洪峰,男,硕士研究生,主要从事医药知识产权保护与成果转化研究。E-mail:。

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洪峰,男,硕士研究生,主要从事医药知识产权保护与成果转化研究。E-mail:。

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近年我国中药新药审批及注册申请现状分析
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洪峰 1 , 褚丹丹 1 , 徐慧芳 1 , 马琳 1 , 李浩 1 , 刘伟 1, 2
中国新药杂志 | 新药注册与审评技术 2021,30(14): 1260-1265
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中国新药杂志 |新药注册与审评技术 2021 , 30 (14) : 1260 -1265
近年我国中药新药审批及注册申请现状分析
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洪峰1 , 褚丹丹1, 徐慧芳1, 马琳1, 李浩1, 刘伟1, 2
作者信息
  • 1北京中医药大学 管理学院,北京 100029
  • 2北京中医药大学 成果转化中心,北京 100029
通讯作者:
刘伟,男,副教授,硕士生导师,主要从事医药知识产权保护与成果转化教学及研究工作。E-mail:。
作者简介:

洪峰,男,硕士研究生,主要从事医药知识产权保护与成果转化研究。E-mail:。

Overall analysis of new Chinese herbal drug approval and registration in recent years
Feng HONG1 , Dan-dan CHU1, Hui-fang XU1, Lin MA1, Hao LI1, Wei LIU1, 2
Affiliations
  • 1Beijing University of Chinese Medicine, School of Management, Beijing 100029, China
  • 2Beijing University of Chinese Medicine, Achievement Transformation Center, Beijing 100029, China
出版时间: 2021-07-30
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通过收集2012—2019年中药新药审批完成及2015—2020年中药新药注册申请的数据,从中药新药审批及申报数量、注册分类、申报主体、剂型分布、治疗领域及来源等多方面进行分类整理,多维度分析其现状,探讨中药新药申报的特点及现存问题,并提供相应建议。2012—2019年,中药新药审批完成数量呈下降趋势,但批准率有所提升;2015—2020年中药新药注册申请数量出现明显下降,6类新药注册申请数量最多,未见2类、4类新药注册申请;申报单位地区分布差异明显,前5名地区申报数量占比高达48%;新药剂型以普通口服制剂为主,治疗领域集中在重大常见疾病领域;新药来源主要为临床验方及科研院校科研成果。总体而言,我国中药新药申报质量有所提升,但申报量处于低谷期,各相关方需多措并举,合力推动中药新药研发。

中药新药  /  审批  /  注册申请  /  现状  /  分析

The paper analyzed the status quo of new Chinese herbal drug (NCHD) approval and registration in recent years, discussed the characteristics and existing problems of NCHD, then provided feasible suggestions. From 2012 to 2019, the number of NCHD approval showed a downward trend, but the approval rate increased. From 2015 to 2020, the number of NCHD registration decreased significantly, the number of category 6 new drugs had the largest number of registration, and there was no registration of category 2 and new drugs of category 4. The regional distribution of declaration units was obvious, the top 5 regions accounting for 48% of the total number of applications. The new drugs were mainly oral preparations, and the treatment field was concentrated in major common diseases. The sources of NCHD were mainly clinical prescriptions and scientific research achievements of scientific research institutions. In general, the quality of NCHD application has been improved, but the amount is at low tide. All stakeholders need to take multiple measures to promote the research and development of NCHD.

new Chinese herbal drug  /  approval  /  registration  /  status quo  /  analysis
洪峰, 褚丹丹, 徐慧芳, 马琳, 李浩, 刘伟. 近年我国中药新药审批及注册申请现状分析. 中国新药杂志, 2021 , 30 (14) : 1260 -1265 .
Feng HONG, Dan-dan CHU, Hui-fang XU, Lin MA, Hao LI, Wei LIU. Overall analysis of new Chinese herbal drug approval and registration in recent years[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1260 -1265 .
  • 教育部人文社会科学研究青年项目(18YICZH106)
  • 中央高校基本科研业务专项资金项目(2020-JYB-ZDGG-068)
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2021年第30卷第14期
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  • 首发时间:2026-10-28
  • 出版时间:2021-07-30
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  • 录用日期:2021-05-13
基金
教育部人文社会科学研究青年项目(18YICZH106)
中央高校基本科研业务专项资金项目(2020-JYB-ZDGG-068)
作者信息
    1北京中医药大学 管理学院,北京 100029
    2北京中医药大学 成果转化中心,北京 100029

通讯作者:

刘伟,男,副教授,硕士生导师,主要从事医药知识产权保护与成果转化教学及研究工作。E-mail:。
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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