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Preliminary thinking on the establishment of China's future pharmacovigilance system
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Ya-juan ZHANG, Hui CHEN, Yue YANG
Chinese Journal of New Drugs | 2021, 30(22) : 2017 - 2023
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Chinese Journal of New Drugs | 2021, 30(22): 2017-2023
Preliminary thinking on the establishment of China's future pharmacovigilance system
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Ya-juan ZHANG, Hui CHEN, Yue YANG
Affiliations
  • School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
Published: 2021-11-30
Outline
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With the increasing number of new drugs on the market, the risk of drug safety also increases. The establishment of pharmacovigilance system is proposed in the Drug Administration Law, which is of great significance to the future research and development of new drugs and drug supervision. Pharmacovigilance system includes management and technical activities. The implementation of China's pharmacovigilance system meets the requirements of new regulations and systems. This article discusses the concept and scope of the implementation of China's future pharmacovigilance system, the key points of the transformation from the adverse reaction monitoring and reporting system to the pharmacovigilance system, and the obligations and responsibilities of all parties in the pharmacovigilance system.

pharmacovigilance system  /  risk control  /  signal recognition
张雅娟, 陈慧, 杨悦. 面向未来的中国药物警戒制度实施的思考. 中国新药杂志, 2021 , 30 (22) : 2017 -2023 .
Ya-juan ZHANG, Hui CHEN, Yue YANG. Preliminary thinking on the establishment of China's future pharmacovigilance system[J]. Chinese Journal of New Drugs, 2021 , 30 (22) : 2017 -2023 .
Year 2021 volume 30 Issue 22
52
9
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  • Online Date:2026-10-28
  • Published:2021-11-30
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  • Accepted:2021-08-09
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    School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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