透过肝素钠事件看美国FDA对质量缺陷药品的风险管理

FDA's risk management of quality-defects of drugs through reviewing heparin sodium event

药品风险管理体系存在漏洞在所难免,如何在处理不良事件的过程中通过科学的方法发现漏洞,采取纠正与预防措施弥补漏洞才是风险管理的核心所在。文中通过剖析美国FDA在肝素钠事件处理过程中采取的措施,总结FDA风险管理优势,为完善我国应对质量缺陷药品采取的风险管理措施提供建议。

The holes in drug risk management system are unavoidable.The core of risk management is how to find and patch the holes with scientific method during the processing of adverse events.Based on analysis of FDA＇s measures taken in heparin sodium event,this article concluded its advantage in drug risk management,and provided suggestions for strengthening Chinese drug risk management in dealing with quality-defects of drugs.