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Overview of the international medicines agencies real world research action plan
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Jun ZHAO, Xiao-na XIN, Jun WANG
Chinese Journal of Clinical Pharmacology | 2025, 41(8) : 1196 - 1200
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Chinese Journal of Clinical Pharmacology | 2025, 41(8): 1196-1200
Drug Evaluation and Administration
Overview of the international medicines agencies real world research action plan
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Jun ZHAO, Xiao-na XIN, Jun WANG
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  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2025-04-28 doi: 10.13699/j.cnki.1001-6821.2025.08.026
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This study examines the practical value of regulatory science action plans in identifying strategic regulatory trends. By analyzing real-world research initiatives from leading international drug regulatory agencies through three dimensions—data platform development, regulatory science implementation, and international harmonization—this paper provides critical references for researchers and regulatory practitioners. Internationally, regulatory authorities have established robust data platforms such as Sentinel, DARWIN EU, and MID-NET. Collaborative partnerships with academic institutions have been formed to advance frontier research topics, while concerted efforts toward international coordination aim to standardize real-world evidence (RWE) applications. Current technical priorities focus on innovations in data infrastructure and research paradigms, particularly methodological advancements in bias mitigation and causal inference frameworks. The expanding application of RWE across the entire drug lifecycle marks a pivotal trend in global pharmaceutical regulation. These developments offer strategic insights for China to accelerate the construction of integrated data platforms and cultivate an innovation-driven regulatory ecosystem.

real world study  /  regulatory agency  /  regulatory science action plan
Jun ZHAO, Xiao-na XIN, Jun WANG. Overview of the international medicines agencies real world research action plan[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (8) : 1196 -1200 . DOI: 10.13699/j.cnki.1001-6821.2025.08.026
Year 2025 volume 41 Issue 8
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doi: 10.13699/j.cnki.1001-6821.2025.08.026
  • Receive Date:2024-11-21
  • Online Date:2026-08-04
  • Published:2025-04-28
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  • Received:2024-11-21
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, 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
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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