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Current situation and prospect of extrapolation of overseas clinical trial data in China
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Guo-shu JIA, Min-hui WANG, Yi LIANG
Chinese Journal of New Drugs | 2023, 32(10) : 969 - 976
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Chinese Journal of New Drugs | 2023, 32(10): 969-976
Current situation and prospect of extrapolation of overseas clinical trial data in China
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Guo-shu JIA, Min-hui WANG, Yi LIANG
Affiliations
  • School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
Published: 2023-05-30
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Since joining the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 2017, China has gradually strengthened the research on the extrapolation of overseas clinical trial data. Standardization of bridging studies and international multi-center clinical trials will become the trend of the times. Extrapolation of overseas clinical trial data is particularly important in the registration process of drugs that have been listed overseas and not listed in China. Usually, the Center for Drug Evaluation of NMPA needs to consider the completeness of clinical trial packages to determine whether a drug is racially sensitive and whether bridging studies are needed. At present, to investigate the influence of ethnic factors on the acceptability of overseas clinical trials, the ICH E5 (R1) Guidelines are generally followed internationally. In addition, the United States, Japan, the European Union, and other ICH member states have issued their own relevant regulations or guidelines. This article introduces the basis and key points of current review of overseas clinical trial data in China, summarizes and analyzes the design of bridging studies based on international experience, and finally puts forward reasonable suggestions for extrapolation of overseas clinical trial data in China.

overseas clinical trial  /  bridging study  /  international multi-center clinical trial  /  ICH
Guo-shu JIA, Min-hui WANG, Yi LIANG. Current situation and prospect of extrapolation of overseas clinical trial data in China[J]. Chinese Journal of New Drugs, 2023 , 32 (10) : 969 -976 .
Year 2023 volume 32 Issue 10
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  • Online Date:2026-03-05
  • Published:2023-05-30
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  • Accepted:2022-05-18
Affiliations
    School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
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表12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
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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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