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Analysis of pre-marketing and post-marketing clinical pharmacology studies in conditional approvals for oncology drugs in China and the United States
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Jing AN1, Cheng-hao GE2, Yang LIU2, 3, Sen LIU3, Chen YIN3, Yi LI4, Jing-can WANG5, Xiao-yuan CHEN2, 3
Chinese Journal of Clinical Pharmacology | 2026, 42(11) : 1631 - 1639
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Chinese Journal of Clinical Pharmacology | 2026, 42(11): 1631-1639
• Drug Evaluation and Administration •
Analysis of pre-marketing and post-marketing clinical pharmacology studies in conditional approvals for oncology drugs in China and the United States
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Jing AN1, Cheng-hao GE2, Yang LIU2, 3, Sen LIU3, Chen YIN3, Yi LI4, Jing-can WANG5, Xiao-yuan CHEN2, 3
Affiliations
  • 1.R&G PharmaStudies Co., Ltd, Beijing 100048, China
  • 2.Clinical Trial Center for Drugs and Medical Devices, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
  • 3.Institute of Regulatory Science for Medical Products, Tsinghua University, Beijing 100084, China
  • 4.Peking Union Medical College Hospital, Beijing 100032, China
  • 5.Shouyao Holdings Co., Ltd., Beijing 100176, China
Published: 2026-06-17 doi: 10.13699/j.cnki.1001-6821.2026.11.021
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Clinical pharmacology research is a crucial component in the evaluation of new drugs, as it effectively reveals the drug’s metabolic processes, mechanisms of action and safety profile. The conditional approval policy typically accelerates the approval process based on limited clinical evidence, which often results in more simplified pre-marketing clinical pharmacology studies, shorter development timelines and smaller sample sizes. Oncology is the therapeutic area with the highest number of conditionally approved drugs, balancing the pre-marketing and post-marketing clinical pharmacology studies requires attention. This paper provides a comparative analysis of the pre-marketing and post-marketing clinical pharmacology studies for conditionally approved oncology drugs by the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA), highlighting the research patterns for different drug types. The study finds that the FDA generally requires more comprehensive clinical pharmacology studies, particularly in special populations (such as patients with impaired liver or kidney function and pediatric populations) and drug interaction studies, while the NMPA’s requirements are relatively simplified. This paper aims to provide insights for the development of oncology drugs in China and discusses the implementation and requirements of clinical pharmacology studies in the development of new drugs under conditional approval.

clinical pharmacology  /  oncology drugs  /  conditional approval  /  accelerated approval  /  National Medical Products Administration  /  U.S. Food and Drug Administration
安静, 葛诚浩, 刘洋, 刘森, 尹晨, 李艺, 王婧璨, 陈晓媛. 中美附条件批准抗肿瘤药物上市前后临床药理学研究的比较分析. 中国临床药理学杂志, 2026 , 42 (11) : 1631 -1639 . DOI: 10.13699/j.cnki.1001-6821.2026.11.021
Jing AN, Cheng-hao GE, Yang LIU, Sen LIU, Chen YIN, Yi LI, Jing-can WANG, Xiao-yuan CHEN. Analysis of pre-marketing and post-marketing clinical pharmacology studies in conditional approvals for oncology drugs in China and the United States[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (11) : 1631 -1639 . DOI: 10.13699/j.cnki.1001-6821.2026.11.021
Appendix
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Year 2026 volume 42 Issue 11
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.11.021
  • Receive Date：2026-04-01
  • Online Date：2026-08-06
  • Published：2026-06-17
Article Data
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History
  • Received：2026-04-01
Affiliations
    1.R&G PharmaStudies Co., Ltd, Beijing 100048, China
    2.Clinical Trial Center for Drugs and Medical Devices, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
    3.Institute of Regulatory Science for Medical Products, Tsinghua University, Beijing 100084, China
    4.Peking Union Medical College Hospital, Beijing 100032, China
    5.Shouyao Holdings Co., Ltd., Beijing 100176, China
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