中美药物警戒体系差异性对比研究及启示

Comparative Study and Enlightenment on the Differences of Pharmacovigilance Systems between China and the United States

摘要: 目的：自新版《药品管理法》对国家建立药物警戒制度提出了更高要求，通过调查分析美国药物警戒体系实施现状，为我国药物警戒体系的运行提供参考建议。方法：采用文献查阅、比较分析法，围绕药物警戒的相关法律法规、组织架构和监测方式等方面，分析比较我国和美国药物警戒体系实施现状。结论：药物警戒的诞生，规范了药品生命周期的整个活动。美国药物警戒体系已相对成熟，因此，我国可借鉴其先进理念，统筹组织机构相互合作、扩大数据库使用范围和加强宣传培训，走出一条适合我国的药物警戒体系建设和实施道路。

Abstract: Objective: The new version of the “Drug Administration Law” puts forward higher requirements for the country to establish a pharmacovigilance system. By investigating the current status of the pharmacovigilance system in the United States, we hope to provide reference suggestions for the implementation of the pharmacovigilance system in China. Methods: Through literature review and comparative analysis, we summarized the current implementation status of the pharmacovigilance system in the United States and China in aspects of relevant laws, regulations, organizational structure and monitoring systems. Conclusion: The birth of pharmacovigilance standardizes the entire activity of the drug life cycle. Compared with the mature pharmacovigilance system in the United States, we concluded various advanced concepts and suggestions for pharmacovigilance, including coordinating mutual cooperation among organizations, expanding the scope of pharmacovigilance, and strengthening publicity and training, so as to blaze a trail for the establishment and implementation of China’s pharmacovigilance system preliminarily.