我国开展药品上市许可持有人制度试点工作情况及相关政策建议  

Recommendation on Pilot Work and Related Policies of Medicine Marketing Authorization Holder System in China

作　　者：赵怀全[1] ZHAO Huaiquan(Dept. of Pharmacy, Beijing Jishuitan Hospital, Beijing 100035, China)

机构地区：[1]北京积水潭医院药剂科,北京100035

出　　处：《中国药房》2017年第4期433-437,共5页China Pharmacy

摘　　要：目的:了解并完善我国开展药品上市许可持有人制度试点工作。方法:分析我国药品上市许可制度存在的问题,以及美国、欧盟的药品上市许可制度的特点,归纳我国药品上市许可持有人制度试点的法律授权与内容,并对试点工作提出相关政策建议。结果与结论:我国药品"生产许可"与"上市许可"合并统一的药品上市许可制度,存在"新药"概念陈旧、药物资源浪费严重、新药研发创新动力不足等问题;而美国、欧盟施行的是药品"生产许可"与"上市许可"相分离的药品上市许可制度,其上市新药数量较多,产能利用率较高,药品安全、质量职责、风险管理等制度相对完善。我国有必要借鉴美国、欧盟的药品"生产许可"与"上市许可"相分离的管理制度,开展药品上市许可持有人制度试点工作。为了保障试点工作的有效开展,建议进一步加强和完善与药品安全管理相关的质量授权管理、药物警戒体系建立、药害救济制度建立等。OBJECTIVE ： To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS： The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS ＆ CONCLUSIONS： There are many problems in the medicine authorization system in China which is the combination of ＂production license＂ and ＂marketing license＂, for exam- ple, the obsolete definition of ＂new drugs＂, the serious waste of drug resources, the insufficient research and development of new drugs. The ＂production license＂ and ＂marketing license＂ are separated in the USA and EU. There are many new drugs, high capaci- ty utilization and perfect system of drug safety, quality control and risk management. In order to ensure the effective implementa- tion of the pilot work, it is suggested to enhance and improve the quality authorization management, the pharmacovigilance system and drug injury relief related to drug safety management.

关 键 词：药品上市许可持有人制度 管理 试点工作 

分 类 号：R95[医药卫生—药学]