Abstract: Objective To understand and analyze status of adverse drug reaction(ADR) monitoring and inspection system for drug manufacturers. Methods Using stratified sampling method, 88 drugmanufacturers of 12 cities in Jiangxi province were extracted. We designed the ADR monitoring and reporting questionaires, and 88 effective questionnaires were returned. Results 88 drug manufacturers all have set up branches of ADR monitoring, and established a ADR-monitoring system. 67.25% manufacturers have full-time personnel, 18.18% manufacturers have reported directly through the network(a total of 65 cases), 48.86% manufacturers have carried regular pooled analytical work, 39.77% have worked on risk assessment, 48.86% manufacturers have written Periodic Safety Update Report(PSUR). Conclusion The work system of ADR monitoring for drug manufacturers has been perfected more and more, but the monitoring has not been widely spreaded, the effect of ADR monitoring is low.

Key words: drug manufacturers, adverse drug reaction monitoring, inspection system