美国药物警戒体系浅析及对我国的启示

摘要

Objective To make suggestions for China's drug safety supervision through an introduction of the status of pharmacovigilance system in the United States (US).Methods Through legal research and document research,the author introduced and analyzed the current situation of pharmacovigilance system in the US from the organization and responsibilities of Food and Drug Administration,system of laws and regulations,risk management and evaluation methods of post-marketing drugs etc.Results The US has now established a relatively mature pharmacovigilance system.This system has a perfect drug safety supervision organization structure,a sound system of laws and regulations and a scientific evaluation system of drug risk management.Conclusion The relevant experience of the US can be learned by China,such as the communication & collaboration between pre-and post-market drug regulatory agencies,instillation of drug risk management and establishment of guidance for industry to promote the development and improvement of China's drug safety supervision.%目的 通过介绍美国药物警戒体系的现状,为我国的药品安全监管工作提出建议.方法 采用法律条款研究、文献研究等方法,从组织机构和职责、法律法规体系、上市后药品风险管理评估方法等方面介绍和分析了美国药物警戒体系的现状.结果 美国目前已建立比较成熟的药物警戒体系,该体系具有较完善的药品安全监管组织架构、健全的法律法规体系及科学的药品风险管理评估体系.结论 我国可借鉴美国的相关经验,从上市前后药品管理部门沟通合作、药品风险管理理念引入、行业指南制订等方面促进我国药品安全监管工作的发展与完善.