希美加群药品风险管理的案例简析

Ximelagatran and Its Risk Management Plan in United States

药品风险管理适用于药品从前体化合物筛选、新药审批、上市后监控以及药品撤出市场的整个过程。通过介绍阿斯利康公司生产的新一代抗凝血药物希美加群(Exanta)从新药审批上市到撤出市场的风险管理相关事件,以期为我国抗凝药物的监测和安全管理工作提供借鉴,从而更好地规范我国的药品市场。

The risk management for pharmaceutical products applies to a life cycle of a new drug development from Investigational New Drug（IND）, New Drug Application（NDA） to post-marketing. It plays a critical role in its withdrawal from the market. In this article we reviewed the risk management events of Ximelagatran（Exanta） which is a new generation of anti-clotting drug manufactured by AstraZeneca, from its new drug approval to its withdrawal. The experience of Ximelagatran risk management in USA might provide a clue for the future risk management of drug safety in China.