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Research and consideration on the application of the European drug regulatory data
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Cui-xiang YIN1, 2, Hai-ling LI1, 2, *
Chinese Journal of New Drugs | 2026, 35(18) : 1952 - 1955
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Chinese Journal of New Drugs | 2026, 35(18): 1952-1955
Research and consideration on the application of the European drug regulatory data
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Cui-xiang YIN1, 2, Hai-ling LI1, 2, *
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • 2State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Published: 2026-09-30 doi: 10.20251/j.cnki.1003-3734.2026.18.007
Outline
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With the deepening of drug review and approval reform and the rapid development of digital technology, it is of great significance to enhance the application of drug review data, as an important basic resource in the field of drug review, for the efficiency improvement and mode transformation of drug review. Based on the European drug regulatory data, this study analyzed data strategy, data quality, data protection, and data application, and proposed ideas on high-quality data management system, data application value release, and stakeholder collaboration mechanism, in order to provide references for the research and application of drug review data in China, promote the value release of data elements, and assist in the high-quality development of drug review digitalization and intelligence.

drug review data  /  basic resources  /  value release  /  digitalization and intelligence  /  high-quality development
殷翠香, 李海玲. 欧洲药品监管数据应用研究与思考. 中国新药杂志, 2026 , 35 (18) : 1952 -1955 . DOI: 10.20251/j.cnki.1003-3734.2026.18.007
Cui-xiang YIN, Hai-ling LI. Research and consideration on the application of the European drug regulatory data[J]. Chinese Journal of New Drugs, 2026 , 35 (18) : 1952 -1955 . DOI: 10.20251/j.cnki.1003-3734.2026.18.007
Year 2026 volume 35 Issue 18
55
8
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doi: 10.20251/j.cnki.1003-3734.2026.18.007
  • Online Date:2026-10-26
  • Published:2026-09-30
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  • Accepted:2025-04-01
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Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
    2State Key Laboratory of Drug Regulatory Science, Beijing 102629, 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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