美国药品生产者注册登记制度的研究及启示

目的:为我国建立药品生产者注册登记制度提供借鉴。方法:从研究美国的药品生产者注册登记制度入手,运用文献研究、对比研究的方法,深入分析美国的药品生产者注册登记制度的法律意义、作用,结合我国存在的问题,探讨对我国建立相关制度的启示。结果与结论:美国的药品生产者注册登记制度可避免审批程序繁多、审批效率低、权责不明晰等弊端,而我国现有的药品生产许可证制度在审批程序、法律意义和作用上存在诸多问题。引入药品生产者注册登记制度具有积极意义,但同时也需要其他相关制度如药品注册审批制度、《药品生产质量管理规范》产品认证制度以及上市许可人制度等的有效配合。

Research and Enlightenment on the Drug Manufacturer Registration and Drug Listing System in USA

OBJECTIVE： To provide references for the establishment of drug manufacturer registration and drug listing system in China. METHODS： Started from the research on the drug manufacturer registration and drug listing system in the USA, the legal meaning and effect of it were analyzed thoroughly and enlightenment on its establishment in China was discussed using literature research and comparative research methods. RESULTS ＆ CONCLUSIONS： Drug manufacturer registration and drug listing system in USA can avoid various procedures for examination and approval, low working efficiency, undefined power and responsibility, etc. There are many problems about drug manufacture license system in the approval process, the role and legal sense in China. It is positive to introduce drug manufacturer registration and drug listing system from the USA, and the co-ordination of other related systems is important, such as strict approval system for drug registration, GMP product certification system and MAH system.