目的:为我国疫苗Ⅳ期临床监管提供可行性建议。方法:利用文献搜集法,通过对美国、澳大利亚、日本、加拿大等具有疫苗Ⅳ期临床监管成功经验国家的特点进行分析总结,再结合我国疫苗监管实际情况,提出建议。结果与结论:国外Ⅳ期临床监管在数据库建设、专家队伍、信息反馈等方面具有强大优势,我国可学习借鉴。 Objective: To provide feasible advice on the clinical supervision of Ⅳ vaccine in China. Methods: By means of literature collection method, this paper analyzed and summarized the characteristics of countries with successful experience in clinical supervision of vaccine phase IV in the United States, Australia, Japan and Canada, and then put forward suggestions based on the actual situation of vaccine regulation in our country. RESULTS AND CONCLUSION: The clinical supervision of stage IV in foreign countries has strong advantages in database construction, expert team, information feedback and so on. Our country can learn from it.