Article(id=1236366102989689262, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, 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=1671638400000, acceptedDateStr=2022-12-22, onlineDate=1772702249524, onlineDateStr=2026-03-05, pubDate=1675008000000, pubDateStr=2023-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702249524, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702249524, creator=13701087609, updateTime=1772702249524, updator=13701087609, issue=Issue{id=1236366095871955240, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='2', pageStart='113', pageEnd='216', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702247826, creator=13701087609, updateTime=1772702896580, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236368817010561584, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236368817010561585, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=205, endPage=209, ext={EN=ArticleExt(id=1236366103207793077, articleId=1236366102989689262, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

For post-approval CMC Changes, ICH Q12 proposed management tools such as categorization of post-approval CMC changes, ECs, PACMP, and PLCM documents. The United States, the European Union and China have different approaches in implementing these management tools. It is of great significance to learn from and refer to the implementation experience of the United States and the European Union for optimizing China's post-approval CMC change management. We hope to change the supervision department's concept of post-approval CMC change management, manage changes by category, and optimize change management tools.

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针对药品批准后CMC变更管理,ICH Q12提出了批准后CMC变更分类、既定条件、批准后变更管理方案、产品生命周期管理文件等管理工具。美国、欧盟和我国在实施这些管理工具上有不同的做法。借鉴和参考美国、欧盟的实施经验,对于优化我国的CMC变更管理具有重要意义。本文对转变监管部门对药品批准后CMC变更管理的理念、对变更进行分类管理、优化变更管理工具提出建议。

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颜久兴,男,副教授,研究方向:药品监管科学。E-mail:
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孙冠男,女,主管药师,研究方向:药品监管科学、临床药学。E-mail:

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孙冠男,女,主管药师,研究方向:药品监管科学、临床药学。E-mail:

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孙冠男,女,主管药师,研究方向:药品监管科学、临床药学。E-mail:

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美国、欧盟和我国实施ICH Q12管理工具的比较研究
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孙冠男 1 , 张鼎衡 2 , 于飞 3 , 左金梁 3 , 周娣 3 , 颜久兴 3
中国新药杂志 | 新药述评与论坛 2023,32(2): 205-209
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中国新药杂志 | 新药述评与论坛 2023, 32(2): 205-209
美国、欧盟和我国实施ICH Q12管理工具的比较研究
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孙冠男1 , 张鼎衡2, 于飞3, 左金梁3, 周娣3, 颜久兴3
作者信息
  • 1天津生物工程职业技术学院,天津 300462
  • 2中国食品药品国际交流中心,北京 100082
  • 3天津医科大学药学院,天津 300070
  • 孙冠男,女,主管药师,研究方向:药品监管科学、临床药学。E-mail:

通讯作者:

颜久兴,男,副教授,研究方向:药品监管科学。E-mail:
A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and China
Guan-nan SUN1 , Ding-heng ZHANG2, Fei YU3, Jin-liang ZUO3, Di ZHOU3, Jiu-xing YAN3
Affiliations
  • 1Tianjin Vocational College of Bioengineering, Tianjin 300462, China
  • 2China Center for Food and Drug International Exchange, Beijing 100082, China
  • 3Pharmacy College, Tianjin Medical University, Tianjin 300070, China
出版时间: 2023-01-30
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针对药品批准后CMC变更管理,ICH Q12提出了批准后CMC变更分类、既定条件、批准后变更管理方案、产品生命周期管理文件等管理工具。美国、欧盟和我国在实施这些管理工具上有不同的做法。借鉴和参考美国、欧盟的实施经验,对于优化我国的CMC变更管理具有重要意义。本文对转变监管部门对药品批准后CMC变更管理的理念、对变更进行分类管理、优化变更管理工具提出建议。

ICH Q12  /  管理工具  /  CMC变更  /  比较研究  /  优化

For post-approval CMC Changes, ICH Q12 proposed management tools such as categorization of post-approval CMC changes, ECs, PACMP, and PLCM documents. The United States, the European Union and China have different approaches in implementing these management tools. It is of great significance to learn from and refer to the implementation experience of the United States and the European Union for optimizing China's post-approval CMC change management. We hope to change the supervision department's concept of post-approval CMC change management, manage changes by category, and optimize change management tools.

ICH Q12  /  management tools  /  CMC changes  /  comparative study  /  optimization
孙冠男, 张鼎衡, 于飞, 左金梁, 周娣, 颜久兴. 美国、欧盟和我国实施ICH Q12管理工具的比较研究. 中国新药杂志, 2023 , 32 (2) : 205 -209 .
Guan-nan SUN, Ding-heng ZHANG, Fei YU, Jin-liang ZUO, Di ZHOU, Jiu-xing YAN. A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and China[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 205 -209 .
2023年第32卷第2期
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  • 首发时间:2026-03-05
  • 出版时间:2023-01-30
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  • 录用日期:2022-12-22
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    1天津生物工程职业技术学院,天津 300462
    2中国食品药品国际交流中心,北京 100082
    3天津医科大学药学院,天津 300070

通讯作者:

颜久兴,男,副教授,研究方向:药品监管科学。E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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