Article(id=1322246383017504954, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, 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=1605456000000, acceptedDateStr=2020-11-16, onlineDate=1793177703861, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177703861, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177703861, creator=13701087609, updateTime=1793177703861, updator=13701087609, issue=Issue{id=1322246381633389353, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='11', pageStart='961', pageEnd='1056', issueExtLink='null', onlineDate='null', pubDate='1623686400000', pubDateStr='2021-06-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177703531, creator='13701087609', updateTime=1793178125547, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248152208486593, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248152212680898, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=961, endPage=970, ext={EN=ArticleExt(id=1322246383470489787, articleId=1322246383017504954, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The research on the value framework of Chinese patent medicine, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Chinese patent medicine is one of important parts in Chinese drug market. It is imperative for new drug development and drug policy-making to establish a drug value assessment framework of Chinese patent medicine embodying the characteristics of traditional Chinese medicine. In this study, PubMed, CNKI and other domestic and foreign literature databases as well as the major international government and academic websites were searched to collect literature, policies, standards, guidelines and expert opinions related to drug value assessment at home and abroad. The methods of literature analysis, content analysis and expert consultation were comprehensively adopted to interpret, compare and analyze the relevant laws and regulations. We obtained the core elements and index system of drug value assessment in the world. According to the characteristics of Chinese medicine and the extensive expert consensus, a set of value assessment framework of Chinese patent medicine covering the whole life cycle from the establishment of the R&D project, pre-clinical application, new drug certificate application and post-marketing use is established, providing strong support for the research and development of new Chinese medicine, post marketing re-evaluation, establishment of clinical medication guidelines, drugs pricing, medical insurance compensation and medication choice of patients.

, authors=Hai-xia DANG1, Jun LIU1, Bing LI1, Rong-li YOU1, Bing-wei CHEN2, Qi-guang CHEN2, Chun-di SHEN3, Zhong WANG1, authorsList=Hai-xia DANG, Jun LIU, Bing LI, Rong-li YOU, Bing-wei CHEN, Qi-guang CHEN, Chun-di SHEN, Zhong WANG, authorCompany=null, correspAuthors=Zhong 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=1322246384179327164, articleId=1322246383017504954, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中成药价值评估指标体系研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

中成药是我国药品市场的重要组成部分,探索建立体现中医药特点的中成药价值评估体系,将是推进以“临床价值”为导向的中药新药研发与应用及相关药品政策制定中的重要环节。本研究在全面检索Pubmed,CNKI等国内外文献数据库、国际上主要国家网站,收集国内外与药品价值评估相关的文献、政策、规范、指南和专家意见,并综合运用了文献分析、内容分析、专家咨询等方法,对相关的法规、文献进行了解读、梳理、对比和分析,结合中医药的特点,在广泛的专家共识基础上,构建了一套涵盖从研发立项、临床前、上市前及上市后全生命周期的中成药价值评估指标体系,为中药新药的研发、上市后再评价、临床用药指南制定、药品定价、医保补偿以及患者的选择用药提供有效支撑。

, authors=党海霞1, 刘骏1, 李兵1, 游蓉丽1, 陈炳为2, 陈启光2, 申春悌3, 王忠1, authorsList=党海霞, 刘骏, 李兵, 游蓉丽, 陈炳为, 陈启光, 申春悌, 王忠, authorCompany=null, correspAuthors=王忠, authorNote=

党海霞,女,博士,硕士生导师,副研究员,主要从事中医药政策管理研究。联系电话:(010)64089693,E-mail:。

, correspAuthorsNote=
王忠,男,研究员,主要从事中医临床研究。联系电话:(010)64093305,E-mail:。
, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=mRpcCRlK71ZcvadlYtAxZg==, magXml=v63gQ45JFo8ZjQRqSBErrQ==, pdfUrl=null, pdf=OgRTa7Xczx96eGcAqn8m2g==, pdfFileSize=1418499, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=l/Aljpz8lQkVQ7NPGa9ehA==, mapNumber=null, fund=null)}, authors=[Author(id=1322246386461028551, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246383017504954, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=danghaixia@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322246386775601353, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246383017504954, authorId=1322246386461028551, language=EN, stringName=Hai-xia DANG, firstName=Hai-xia, middleName=null, lastName=DANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1Institute of Basic Clinical Medicine, China Academy of Chinese Medical Science, Beijing 100700; China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322246387169865930, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246383017504954, authorId=1322246386461028551, language=CN, stringName=党海霞, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1中国中医科学院中医临床基础医学研究所,北京 100700, bio={"content":"

党海霞,女,博士,硕士生导师,副研究员,主要从事中医药政策管理研究。联系电话:(010)64089693,E-mail:。

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党海霞,女,博士,硕士生导师,副研究员,主要从事中医药政策管理研究。联系电话:(010)64089693,E-mail:。

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中成药价值评估指标体系研究
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党海霞 1 , 刘骏 1 , 李兵 1 , 游蓉丽 1 , 陈炳为 2 , 陈启光 2 , 申春悌 3 , 王忠 1
中国新药杂志 | 新药述评与论坛 2021,30(11): 961-970
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中国新药杂志 |新药述评与论坛 2021 , 30 (11) : 961 -970
中成药价值评估指标体系研究
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党海霞1 , 刘骏1, 李兵1, 游蓉丽1, 陈炳为2, 陈启光2, 申春悌3, 王忠1
作者信息
  • 1中国中医科学院中医临床基础医学研究所,北京 100700
  • 2东南大学,南京 210096
  • 3南京中医药大学,南京 210023
通讯作者:
王忠,男,研究员,主要从事中医临床研究。联系电话:(010)64093305,E-mail:。
作者简介:

党海霞,女,博士,硕士生导师,副研究员,主要从事中医药政策管理研究。联系电话:(010)64089693,E-mail:。

The research on the value framework of Chinese patent medicine
Hai-xia DANG1 , Jun LIU1, Bing LI1, Rong-li YOU1, Bing-wei CHEN2, Qi-guang CHEN2, Chun-di SHEN3, Zhong WANG1
Affiliations
  • 1Institute of Basic Clinical Medicine, China Academy of Chinese Medical Science, Beijing 100700; China
  • 2Dongnan University, Nanjing 210096 China
  • 3Nanjing University of Chinese Medicine, Nanjing 210023, China
出版时间: 2021-06-15
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中成药是我国药品市场的重要组成部分,探索建立体现中医药特点的中成药价值评估体系,将是推进以“临床价值”为导向的中药新药研发与应用及相关药品政策制定中的重要环节。本研究在全面检索Pubmed,CNKI等国内外文献数据库、国际上主要国家网站,收集国内外与药品价值评估相关的文献、政策、规范、指南和专家意见,并综合运用了文献分析、内容分析、专家咨询等方法,对相关的法规、文献进行了解读、梳理、对比和分析,结合中医药的特点,在广泛的专家共识基础上,构建了一套涵盖从研发立项、临床前、上市前及上市后全生命周期的中成药价值评估指标体系,为中药新药的研发、上市后再评价、临床用药指南制定、药品定价、医保补偿以及患者的选择用药提供有效支撑。

中成药  /  价值评估  /  指标体系

Chinese patent medicine is one of important parts in Chinese drug market. It is imperative for new drug development and drug policy-making to establish a drug value assessment framework of Chinese patent medicine embodying the characteristics of traditional Chinese medicine. In this study, PubMed, CNKI and other domestic and foreign literature databases as well as the major international government and academic websites were searched to collect literature, policies, standards, guidelines and expert opinions related to drug value assessment at home and abroad. The methods of literature analysis, content analysis and expert consultation were comprehensively adopted to interpret, compare and analyze the relevant laws and regulations. We obtained the core elements and index system of drug value assessment in the world. According to the characteristics of Chinese medicine and the extensive expert consensus, a set of value assessment framework of Chinese patent medicine covering the whole life cycle from the establishment of the R&D project, pre-clinical application, new drug certificate application and post-marketing use is established, providing strong support for the research and development of new Chinese medicine, post marketing re-evaluation, establishment of clinical medication guidelines, drugs pricing, medical insurance compensation and medication choice of patients.

Chinese patent medicine  /  value assessment  /  indicator system
党海霞, 刘骏, 李兵, 游蓉丽, 陈炳为, 陈启光, 申春悌, 王忠. 中成药价值评估指标体系研究. 中国新药杂志, 2021 , 30 (11) : 961 -970 .
Hai-xia DANG, Jun LIU, Bing LI, Rong-li YOU, Bing-wei CHEN, Qi-guang CHEN, Chun-di SHEN, Zhong WANG. The research on the value framework of Chinese patent medicine[J]. Chinese Journal of New Drugs, 2021 , 30 (11) : 961 -970 .
  • 原国家食品药品监督管理局政策研究课题资助项目(G20150I)
参考文献 引证文献
排序方式:
[1]
US FDA. PDUFA Ⅵ Implementation Plan: Benefit-Risk Assessment In Drug Regulatory Decision-Making[EB/OL]. (2018-03-30). https://www.fda.gov/media/112570/download.
[2]
RAWLINS MD, CULYER AJ. National Institute for Clinical Excellence and its value judgments[J]. BMJ, 2004, 329(7459): 224-227.
[3]
SCHNIPPER LE, DAVIDSON NE, WOLLINS DS, et al. American society of clinical oncology statement: a conceptual framework to assess the value of cancer treatment options[J]. J Clin Oncol, 2015, 33(23): 2563-2577.
[4]
ICER. 2020-2023 Value Assessment Framework[EB/OL]. (2020-01-31) [2020-05-25]. https://icer-review.org/wp-content/uploads/2019/05/ICER_2020_2023_VAF_013120-4.pdf.
[5]
李静, 商洪才, 赵晨. 药物临床试验质量监查的问题分析对策以及中成药上市后再评价领域监查问题[J]. 中国新药杂志, 2019, 28(18): 2184-2188.
[6]
国家食品药品监督管理局. 关于深化药品审评审批改革进一步鼓励创新的意见[EB/OL]. (2013-02-22). http://samr.cfda.gov.cn/WS01/CL0844/78576.html.
[7]
中华人民共和国中央政府. 中共中央国务院关于促进中医药传承创新发展的意见[EB/OL]. (2019-10-26). http://www.gov.cn/zhengce/2019-10/26/content_5445336.htm.
2021年第30卷第11期
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  • 首发时间:2026-10-28
  • 出版时间:2021-06-15
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  • 录用日期:2020-11-16
基金
原国家食品药品监督管理局政策研究课题资助项目(G20150I)
作者信息
    1中国中医科学院中医临床基础医学研究所,北京 100700
    2东南大学,南京 210096
    3南京中医药大学,南京 210023

通讯作者:

王忠,男,研究员,主要从事中医临床研究。联系电话:(010)64093305,E-mail:。
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2种不同金属材料的力学参数
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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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