Abstract: ObjectiveTo analyze the pattern of change of ADR monitoring data in China over the past ten years so as to point out some issues worthy of attention. Methods The data in the annual report on ADR monitoring issued by the state drug regulatory agencies from 2009 to 2018 was analyzed, the trend of change explored and the reasons were analyzed. Results The number and quality of ADR reports in China have been improved rapidly in the past decade, the coverage of monitoring networks has been expanding, and the ability of risk identification and control has been enhanced. However, there are still some problems worthy of attention and the need for improvement. Conclusion Drug regulatory agencies and ADR monitoring centers should conduct in-depth research based on the risk highlighted by the monitoring data and on the experience accumulated over the years, shift priorities and work hard to improve the level of monitoring.

Key words: adverse drug reaction monitoring, annual report, trend analysis