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New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China
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Yi-chao ZHUO1, Hui-qing XU1, Pei-pei LIN1, Ji-yin ZHOU2, *
Chinese Journal of New Drugs | 2026, 35(19) : 2048 - 2054
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Chinese Journal of New Drugs | 2026, 35(19): 2048-2054
New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China
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Yi-chao ZHUO1, Hui-qing XU1, Pei-pei LIN1, Ji-yin ZHOU2, *
Affiliations
  • 1 The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
  • 2 The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
Published: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.004
Outline
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Objective:

To analyze the new requirements and challenges in the data governance chapter of China’s 2026 edition of Good Clinical Practice (GCP), and to propose corresponding strategies.

Methods:

This paper systematically summarizes the core provisions in the new GCP, including the full data lifecycle, blinding management, and computerized system standards, and explores of practical implementation challenges in the context of China’s specific circumstances.

Results:

The new GCP faces challenges in China, including inconsistencies between regulatory frameworks and technical standards, great difficulties in the execution of blinding management, imperfect development and validation of computerized systems, and insufficient awareness and capabilities in data governance.

Conclusion:

China’s regulatory requirements for drug clinical trials should further align with international concepts; management mindsets should be adjusted; standard operating procedures should be updated in a timely manner; and coordinated efforts should be made to improve the regulatory framework, optimize blinding processes, promote standardization of computerized systems, and strengthen data governance training and cultural development, so as to establish a scientific and efficient clinical trial data governance system.

Good Clinical Practice  /  data governance  /  data lifecycle  /  blinded management  /  computerized system
卓一超, 许慧清, 林培培, 周吉银. 新版《药物临床试验质量管理规范》对我国药物临床试验数据治理的新要求、新挑战与对策. 中国新药杂志, 2026 , 35 (19) : 2048 -2054 . DOI: 10.20251/j.cnki.1003-3734.2026.19.004
Yi-chao ZHUO, Hui-qing XU, Pei-pei LIN, Ji-yin ZHOU. New requirements, challenges, and countermeasures of the updated Good Clinical Practice for drug clinical trial data governance in China[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2048 -2054 . DOI: 10.20251/j.cnki.1003-3734.2026.19.004
Appendix
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Year 2026 volume 35 Issue 19
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.19.004
  • Receive Date：2026-07-14
  • Online Date：2026-10-29
  • Published：2026-10-15
Article Data
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History
  • Received：2026-07-14
Funding
Affiliations
    1 The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
    2 The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
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红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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