从莲必治注射液临床集中监测试验方案探讨企业风险管理模式

Discussion on Risk Mangement in Pharmaceutical Enterprise and Program Design of Lianbizhi Injection's Clinical Monitoring Trial

介绍开展莲必治注射液上市后临床集中监测的方案设计,对完善莲必治注射液的生产工艺与质量标准,提高莲必治注射液的安全性起到积极的作用。同时,试图通过药品上市后集中监测试验的开展,探索适合该品种的风险管理机制,为推动国内中药注射剂生产企业主动开展药品不良反应监测和上市后安全风险管理提供借鉴。

By introducing program design of post-market Lianbizhi injection＇s clinical monitoring trial, a positive role was played to improve Lianbizhi injection＇s production process and quality, standards, and enhance the security of Lianbizhi injection＇s use. At the same time, by making Lianbizhi injection＇s clinical monitoring trial, risk mangement mesures of Lianbizhi injection was discussed. Domestic phar- maceutical enterprises of traditional chinese medicine injection should be active in adverse drug reaction monitoring and risk mangemnet.