各国疫苗Ⅳ期临床监管对我国的借鉴意义

Reference Significance of Ⅳ Period Clinical Supervision of Vaccine in Foreign Countries

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 suggestions to the domestic IV phase clinical supervision of vaccine. Methods ： By literature researching, countries which have successful experience in IV phase clinical supervision of vaccine are analyzed and compared, such as United States, Australia, Japan, Canada and so on. Combined with Chinese actual situation, suggestions are proposed. Results ＆ Conclusions ： The IV phase clinical supervision of vaccine in foreign countries has advantages on aspects of database construction, experts team, information feedback, etc, and has significant value for reference.