Safety Monitoring of Traditional Chinese Medicine Injections: the Current Status and Risk Management
关于中药注射剂安全性监测现状与风险管理的思考

After a systemic review of the research and developmental history and the current status of safety surveillance of traditional Chinese medicinal injections (TCMIs), the authors analyzed the characteristics and risk factors of recent safety events of TCMIs and proposed to reinforce the approval procedure for drug registration, strengthen quality control in manufacturing, and standardize clinical applications, etc. In addition, the authors propose that the manufacturers should establish a standardized systemic risk management protocol to actively and voluntarily involve in safety evaluation and surveillance. Exploring the active monitoring methodology and system construction by implementing intensive surveillance and strengthening basic science research are crucial in the understanding and control of the risk of TCMIs.