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Volume 38 Issue 12
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 38 Issue 12
20 December 2024
Supervision & Administration
A Comparative Analysis and Reflection on the PIC/S GMP Annex for Herbal Medicinal Products Production with the Chinese GMP Appendices for Traditional Chinese Medicine Decoction Pieces and Preparations, and Related Regulations
Wu Jing, Wang Han, Sun Wen, Li Na, Yang Xifan, Wang Lin
2024, 38(12): 1345-1350.
https://doi.org/10.16153/j.1002-7777.20240172
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Supervision & Administration
General Considerations for Pharmaceutical Issues in the Communication of Innovative Chemical Drug at Different Application Stages for Registration
Ren Feng, Jiang Tao, Chen Aiping, Liu Juan, Ren Lianjie, Fan Yi
2024, 38(12): 1351-1356.
https://doi.org/10.16153/j.1002-7777.2024-08-0033
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Supervision & Administration
Analysis of the Current Situation and Existing Problems of Drug Import Filing
Li Lijie, Chen Jijian, Gao Qingquan, Qi Yaqiao
2024, 38(12): 1357-1362.
https://doi.org/10.16153/j.1002-7777.20240214
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Supervision & Administration
Exploring the Importance of Quality Control of Pharmaceutical Excipients from the Pollution Incident of Ethylene Glycol and Diethylene Glycol
Lu De, Xu Wenyan, Pei Yusheng, Xiao Yan
2024, 38(12): 1363-1370.
https://doi.org/10.16153/j.1002-7777.2024-09-0032
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Supervision & Administration
Research on Optimizing Early-Warning Strategies for Supply of Reference Drug Based on Data Analysis
Xie Jingxin, Cheng Xianlong, Qiao Jing, Wei Feng, Zhao Zongge, Sun Huimin
2024, 38(12): 1371-1378.
https://doi.org/10.16153/j.1002-7777.2024-08-0028
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Supervision & Administration
Exploration of Radiation Safety Management in Radioactive Drug Testing Laboratories
Pei Yunfei, Zhang Wenzai, Wang Quanzhu, Zhang Wei, Ni Xunsong, Guo Yaxin
2024, 38(12): 1379-1386.
https://doi.org/10.16153/j.1002-7777.2024-09-0035
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Supervision & Administration
Research and Establishment of the Quality Assessment Standard Method of Cosmetic Adverse Reaction Reporting in China Based on the International ADR Monitoring
Shen Lu
2024, 38(12): 1387-1398.
https://doi.org/10.16153/j.1002-7777.2024-08-0049
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Regulatory Tehnology
Suggestions for the Hygroscopic Chemical Reference Substances in Drug Regulatory Application
Liu Yi, Wu Jingfang, Guo Xianhui, Ding Yi, Chen Hua, Ning Xiao, Cao Jin
2024, 38(12): 1399-1403.
https://doi.org/10.16153/j.1002-7777.20240519
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Regulatory Tehnology
Quality Risk Analysis of Human Prothrombin Complex Concentrate Extraction and Its Combination with Plasma for Blood Product Preparation
Ma Yinlin, He Xuefeng, Gou Yangmei, Kong Liya, Shan Lin
2024, 38(12): 1404-1412.
https://doi.org/10.16153/j.1002-7777.2024-09-0057
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