关键词: 药品不良反应, 检查, 问题思考, 药物警戒, 风险管理

Abstract: Objective To discuss the main problems of the reporting and monitoring of adverse drug reactions in drug manufacturers, to provide suggestions for promoting drug manufacturers to fulfill the responsibility of drug safety through the analysis of the inspection findings on adverse drug reaction reporting and monitoring. Methods To classify and summarize the defect items for the non-compliance and recommendations of the 11 manufacturers which were inspected recently, and analyze the problems and causes on the adverse drug reaction reporting and monitoring of drug manufacturers. Results & Conclusion At present, drug manufacturers have improved adverse drug reaction monitoring work, but there are still varying degrees of problems as following in some companies: the awareness of the main responsibility for drug safety is not in place, the risk information collection capacity is not high, the understanding to carry out drug safety risk management concepts and methods is incomplete, the feedback data analysis and utilization capacity is not high and so on. It needs to intensify policy guidance from the regulatory level, enhance education and training, strengthen supervision and inspection, and promote drug manufacturers to fulfill the main responsibility for drug safety.

Key words: drug adverse reaction, inspection, analysis of problem, pharmacovigilance, risk management