Abstract: Objective To offer reference for China, Post-marketing Surveillance System of Vaccine in European Union was introduced. Methods Literatures, regulations and laws relating to post-marketing surveillance system of vaccine were collected. Results Specific requirements were proposed by European Union through legal framework. Risk management system, periodic safety update report and additional monitoring list were utilized to recognize potential adverse events signal. Reevaluation of vaccine was proceeded by post-authorization safety studies. Conclusion European Union has established unified long-term monitoring system, completed drug safety communication mechanism and put the idea of risk control all through the process of surveillance.

Key words: vaccine, post-marketing surveillance system, reference