欧盟疫苗上市后安全监测体系研究

Research on Post-marketing Surveillance System of Vaccine in European Union

目的通过介绍欧盟疫苗上市后安全监测体系,为我国疫苗上市后监管提供参考。方法采用文献分析的方法,围绕疫苗上市后监测体系,搜集有关法律法规文献。结果通过法律框架,欧盟提出了疫苗安全监测的特殊要求,以统一的数据库为基础,采用风险管理系统、定期安全性更新报告、设置重点监测名单等措施识别潜在不良反应信号,并通过注册后安全性研究对疫苗安全进行再评价。结论欧盟建立了统一、长期监测体系和完善的药品安全沟通机制,将风险控制理念贯穿始终,这对我国有一定的借鉴意义。

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.