Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the problems of China’s pharmacovigilance organization system, and to provide targeted suggestions for improving it. Methods The relevant literature at home and abroad was reviewed to compared the differences in pharmacovigilance organizations in the United States, the European Union, Japan and China. Then, the problems of China’s pharmacovigilance organization management were found out. Results and Conclusion China’s pharmacovigilance organizational system has problems such as inadequate organizational setup, immature institutional construction, no coordination mechanism for pharmacovigilance practice, and industry associations of third-party organizations having no role to play. It is recommended to carry out theoretical and methodological research on the pharmacovigilance organizational system to provide practical guidance for optimizing the system with Chinese characteristics.

Key words: pharmacovigilance organization, system optimization, policy suggestion