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Volume 39 Issue 11
Directed：
National Medical Products Administration
Sponsored:
National Institutes for Food and Drug Control
Editor in Chief:
Sang Guowei
Edited & Published:
Editors Agency of
Chinese Pharmaceutical Affairs
ISSN:
1002-7777
CN:
11-2858/R
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Volume 39 Issue 11
20 November 2025
Supervision & Administration
Capacity Building and Continuous Improvement of WHO-NRA Assessment on Laboratory Testing and Lot Release in China
Xu Hongshan, Zhang Jie, Liu Xinyu, Mao Qunying
2025, 39(11): 1209-1218.
https://doi.org/10.16153/j.1002-7777.2025-06-0038
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Supervision & Administration
Overview and Analysis of the Pre-Registration Communication System for Medical Devices in China and The United States
Li Xin, Pang Bo, Li Yaohua
2025, 39(11): 1219-1225.
https://doi.org/10.16153/j.1002-7777.2025-05-0037
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Supervision & Administration
A Brief Discussion on the Regulatory Service Strategies for High-Quality Development of Generic Drugs Based on the Current Situation in the Yangtze River Delta Regio
Fan Yi, Chen Aiping
2025, 39(11): 1226-1233.
https://doi.org/10.16153/j.1002-7777.2025-08-0044
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Supervision & Administration
Research on the Construction of “Dual-Cycle-Tiered” Assessment and Evaluation Mechanism for Drug Inspectors
Liu Yingying
2025, 39(11): 1234-1243.
https://doi.org/10.16153/j.1002-7777.2025-07-0050
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Quality Management
Overview of Research on Oral Films Based on QbD
Wang Jingwen, Zuo Ning, Ma Xun, Yin Lihui, Chen Hua
2025, 39(11): 1244-1256.
https://doi.org/10.16153/j.1002-7777.2025-02-0042
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Quality Management
Study on Proficiency Testing of Toxicologic Pathology Morphological Examination in Drug Safety Evaluation
Li Shanshan, Zhang Di, Li Shuangxing, Huo Guitao, Yang Yanwei, Xiang Xinhua, Qu Zhe
2025, 39(11): 1257-1264.
https://doi.org/10.16153/j.1002-7777.2025-08-0021
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Regulatory Technology
Determination of the Coating Thickness of Pancreatic Kininogenase Enteric-Coated Tablets Using Raman Spectroscopy Imaging
Wang Yue, Han Miaomiao, Fan Huihong, Zou Wenbo
2025, 39(11): 1265-1271.
https://doi.org/10.16153/j.1002-7777.2025-07-0009
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Regulatory Technology
Research on Content Determination Methods for Hydrocortisone Sodium Succinate
Sun Yue, Luo Shuqing, Hu Xinyue, Zhou Zheng, Cai Yi, Li Jing
2025, 39(11): 1272-1281.
https://doi.org/10.16153/j.1002-7777.2025-06-0021
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Regulatory Technology
Determination of Related Substances in Compound Rutin Tablets
He Jiajia, Zhang Wenqi, Lou Yongjun
2025, 39(11): 1282-1297.
https://doi.org/10.16153/j.1002-7777.2025-06-0017
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