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A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and China
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Guan-nan SUN1, Ding-heng ZHANG2, Fei YU3, Jin-liang ZUO3, Di ZHOU3, Jiu-xing YAN3
Chinese Journal of New Drugs | 2023, 32(2) : 205 - 209
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Chinese Journal of New Drugs | 2023, 32(2): 205-209
A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and China
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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
Published: 2023-01-30
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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
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 .
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  • Online Date：2026-03-05
  • Published：2023-01-30
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  • Accepted：2022-12-22
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
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表12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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