欧盟药物警戒体系建立运行与实施进展

Establishment and Operation of EU Pharmacovigilance System and Its Implementation Progress

目的对欧盟药物警戒体系及其实施进展进行介绍,为完善我国药物警戒体系提供参考。方法通过查阅国内外文献,运用文献研究法进行分析。结果在欧盟药物警戒体系内,其法律法规文件完整规范,各相关方职责明确,程序简化合理,信息公开透明,可合理有效的保障药品整个生命周期的安全。结论我国应借鉴欧盟药物警戒体系,提高我国药品安全监测能力。

Objective According to the introduction of EU pharmacovigilance system and its implementation progress, suggestions were put forward to provide the example and reference for perfecting and developing pharmacovigilance system of China. Methods Literature study was used to analyze the foreign and domestic materials. Results Within the EU pharmacovigilance system, there are complete and standard legal documents, clear obligation, simplified and reasonable procedures and public information to effectively guarantee the safety of drugs throughout the life cycle. Conclusion We should learn from EU pharmacovigilance system to improve our ability to monitor drug safety.