摘要
目的对欧盟药品风险管理计划(RMP)的发展历程、实施要素、实施效果等进行研究,以期为我国开展药品RMP提供建议。方法主要采用文献分析法,检索中外文献和欧洲药品管理局(EMA)网站,了解欧盟RMP内容。结果欧盟上市许可申请人(MAA)/上市许可持有人(MAH)制定RMP来确保药品风险效益平衡,相关法规和指南完善、组织结构协作分工,已取得良好效果。结论建议我国从法律层面要求企业制定RMP,作为新药申请材料的一部分,同时完善相关体系,推进RMP发展,实现药品全生命周期的风险管理。
Objective To provide suggestions to conduct risk management plan in China by introducing the development, implementation elements and implementation effect of risk management plan （RMP） in European Union. Methods The material of RMP in European Union was summarized through analyzing literature and searching European Medicines Agency （EMA） official website. Results European Union regulations require marketing authorization applicant （MAA） / marketing authorization holder （MAH） develop RMP to ensure drug risk-benefit balance, with perfect regulations and guidelines and organization structure, and has achieved good results. Conclusion China could require companies to develop RMP from a legal perspective, and improve the relevant system, promote the development of RMP, so as to achieve full life-cycle drug risk management.
出处
《中国药物警戒》
2016年第9期529-532,536,共5页
Chinese Journal of Pharmacovigilance
关键词
风险管理计划
新药申请
风险管理
risk management plan
registration
risk management
