Abstract: Objective To establish a drug safety assessment indicator system and build a drug safety index. Methods The sources of drug safety risks were identified and monitored by means of literature research and field research, and drug safety indicator system and indexes were established. Results The drug safety index provided a comprehensive assessment of multiple safety indicators related to drug safety in multiple regions over the same time period. Conclusion Based on the comprehensive evaluation Results, the countermeasures and opinions on the strengthening of drug safety risk management were put forward, which provided decision support and reference for government and drug regulatory agencies.

Key words: drug safety, risk assessment, indicators, index