国家药品抽检风险管理主要举措分析与建议

Analysis and Suggestions on Main Measures of Risk Management in National Drug Sampling and Testing

目的分析国家药品抽检药品质量安全风险管理的主要创新性举措及成效,为更好开展药品上市后抽检提供参考。方法采用回顾性研究方法,分析2014~2019年国家药品抽检工作中时间管理、专项抽检、严重风险处置机制、一般风险提示机制、信息公开等主要举措对药品质量安全风险管理发挥的作用。结果国家药品抽检采取的一系列举措加强和完善了风险排查-处置-信息公开的闭环管理链。结论国家药品抽检采取的药品质量安全风险举措有利于减少公众用药安全隐患,对地方药品抽检具有良好的示范和指导作用,建议借鉴美国和欧盟的药品监管经验、加强疫苗、进口药品和一致性评价过评药品的抽检、个性化设计检验研究策略,不断完善国家药品抽检风险管理机制。

OBJECTIVE To analyze the main measures of the drug quality and safety risks management in the national drug sampling and testing,and provide reference for improving the drug sampling and testing after listing.METHODS Using retrospective research methods to analyze the effects of the deadline management,special item(special topic)sampling and testing,serious quality risk disposal mechanism,nonserious quality risk warning mechanism,information disclosure on drug quality and safety risk management during the national drug sampling and testing in 2014-2019.RESULTS A series of measures improved a timely,efficient and complete closed-loop response chain of risk identification-disposal-disclosure.CONCLUSION The main measures can help reduce public drug safety risks and have good demonstration and guiding significance for local drug sampling and testing.It is recommended to continuously improve the risk management mechanism,such as learning from the US and EU drug regulatory experience,strengthening the sampling and testing of vaccines,imported drugs and consistency evaluated drugs,and personalized designing test and research strategies.