葛根素注射液上市后安全性监测的探索(二)——不良反应信号的发现与监管

Exploration of Safety Monitoring of Puerarin Injection in Post-market Surveillance ADR Signal Detection and Surveillance(2)

通过对葛根素注射液上市后安全性监测历程的回顾和相关专题研究工作的总结,探讨不良反应信号的发现、监测方法、监管模式和监管效果的内在规律,提出在药品上市后监管工作中政府、制药企业和医疗机构各自责任与作用的建议。

By reviewing the post-market safety surveillance and summarizing the thematic study for puerarin injection,this paper discussed the ADR signal discovery and monitoring methodology,modality and efficacy of surveillance and the internal rules.It puts forward suggestions to the responsibility and functions of the government,pharmaceutical companies and medical institutions.