国外药品风险管理案例对制定中药注射剂上市后风险管理计划启示

摘要

随着中药注射剂的广泛应用，其不良反应也日渐引起重视。本文通过分析中药注射剂风险来源因素，以国内外药品风险管理的案例为借鉴，引入风险管理可以促进药品全过程安全管理的规范化与标准化，最大化药品的收益，最小化药品的风险，从而最终达到风险最小化的目的。%Extensive use of traditional Chinese medicine injections has draw people’s eye toward adverse reactions,that is the reason in this research we analyzed various risk factors of traditional Chinese medicine injections,took examples from domestic and foreign drug risk management,and concluded introducing risk management can enhance safety control of a drug during the whole process of maximi-zing the drug benefits while minimizing various risks.