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摘要： Objective To analyze the problems of China’s pharmacovigilance legislation, and to provide some suggestions for improving it. Methods Relevant literature at home and abroad were studied to compare the laws and regulations of the United States, the European Union, Japan and China. Then, the problems of China’s pharmacovigilance legislation were analyzed. Results and Conclusion The Chinese pharmacovigilance legislation has such problems as nontransparent formulation process, poor dynamic adaptability, insufficient use of the attention mechanism, fragmentation of laws and regulations, and poor connection of laws and regulations, which should be optimized. It is recommended to carry out theoretical and methodological research on pharmacovigilance legislation to provide practical guidance for optimizing pharmacovigilance legislation with Chinese characteristics.
