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中文
Volume 40 Issue 10
Directed：
National Medical Products Administration
Sponsored:
National Institutes for Drug Control
Editor in Chief:
AN Fudong
Edited & Published:
Editors Agency of
Chinese Pharmaceutical Affairs
ISSN:
1002-7777
CN:
11-2858/R
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Volume 40 Issue 10
20 October 2026
Supervision & Administration
Reflections on the Evaluation Framework for Artificial Intelligence-Generated Clinical Evidence in Drug Regulation
Li Min, Fan Yi, Pan Jianhong, Cao Shang, Wang Jingzhao, Yu Huan
2026, 40(10): 1161-1170.
https://doi.org/10.16153/j.1002-7777.2026-05-0025
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Supervision & Administration
Comparative Analysis and Recommendations for China’s Policies on the Integrated Operation of Pharmaceutical Wholesale and Retail
Wang Xiuyun, Chen Dandan, Liao Qian
2026, 40(10): 1171-1178.
https://doi.org/10.16153/j.1002-7777.2025-05-0023
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Supervision & Administration
Inspection Methods and Graded Risk Control for Data Integrity of LIMS and MES in Pharmaceutical Production
Li Zimu, Li Sumei
2026, 40(10): 1179-1186.
https://doi.org/10.16153/j.1002-7777.2026-06-0029
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Supervision & Administration
Quality Control Strategies for Continuous Manufacturing of Chemical Drugs under ICH Q13
Yue Ruiqi, Li Huiyi
2026, 40(10): 1187-1192.
https://doi.org/10.16153/j.1002-7777.2026-07-0042
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Supervision & Administration
Design of an Intelligent Drug Testing Information System with Samples as the Main Line
Zhang Weimin, Li Xiuji, Kang Shuai, Hu Xiaowen, Dong Zhongping, Zhong Xuanwei
2026, 40(10): 1193-1199.
https://doi.org/10.16153/j.1002-7777.2026-03-0041
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Supervision & Administration
Post-Marketing Change Management Policy Analysis of Autologous CAR-T Therapy Products in China, the United States, and the European Union
Li Yingmeng, Shi Wenyu, Yao Dongning, Zhang Liying
2026, 40(10): 1200-1211.
https://doi.org/10.16153/j.1002-7777.2025-12-0011
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Supervision & Administration
Discussion and Practical Prospects of Constructing a Digital Intelligence-Based Medical Device and Drug-Device Combination Products Classification Management System
Wang Yue, Zheng Jia, Jiang Xiao, Cui Le, Zhang Chunqing, Zhu Jiong
2026, 40(10): 1212-1219.
https://doi.org/10.16153/j.1002-7777.2025-10-0058
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Regulatory Science for Innovative Drugs
Clinical Considerations on the Research and Development of New Traditional Chinese Medicine Compound Preparations for Premature Ventricular Contractions without Structural Heart Disease
Zhao Zhihong, An Na
2026, 40(10): 1220-1223.
https://doi.org/10.16153/j.1002-7777.2026-04-0050
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Assessment Techniques & Guidance: Special Column on Technical Assessment of Biologics
Significance and Challenges of Stability Studies for Biological Products
Qiu Xiao, Yang Fei, Guo Shuyang, Wei Wei
2026, 40(10): 1224-1229.
https://doi.org/10.16153/j.1002-7777.2026-08-0035
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