刍议企业在药品上市后风险管理中的责任

Role of enterprises in the risk management on post-marketing drugs

目的本文旨在阐述药品企业以取利者的身份应当在药品风险管理中担当的责任与起到的作用。方法重点采用比较、分析方法,对社会、政府以至企业三方展开论述,并结合具体案例进行深入剖析。结果企业必须将维护公众健康权益作为谋取商业利益的基础,同时必须努力发掘和控制药品的风险以降低药品风险所造成的损害。结论企业在药品风险管理中负有不可推脱的重要责任,并且企业要以预防风险为基础,其利益选择与政府风险管理从宏观上讲存在高度的一致性。

Objective This article aims to describe the role of enterprises,stakeholders with commercial interests, in the risk management on post-marketing drugs. Method To emphasize analysis, use the methods of comparison, and discuss from the relationship of society, government to enterprises as well as analyze with actual cases. Result Enterprises have to safeguard the healthy interests of public, and take it as the developing basis; And, enterprises must make efforts to develop and control the risk of drugs to reduce the risk. Conclusion Enterprises have the important and indispensable responsibility in risk management, and it is first necessary to protect the risk. The interests of enterprises is coherent with government on risk management of drugs.