从美国PDUFA看我国的药品审批行政收费制度  

Discussion on China Drug Administrative Charges with Reference to U.S. PDUFA

作　　者：唐健元[1] 赵智恒[1,2] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]沈阳药科大学工商管理学院

出　　处：《中国药事》2013年第6期564-567,共4页Chinese Pharmaceutical Affairs

摘　　要：目的探讨建立科学的药品注册审批机制。方法对中美两国药品行政审批收费制度进行比较,阐释美国处方药使用者收费法案(Prescription Drug User Fee Act,PDUFA)带给我国的启示,探讨相应的改革措施。结果与结论美国PDUFA对我国药品注册审批制度改革具有借鉴意义。Objective To discuss how to establish a scientific mechanism for examination and approval of drug registration in China. Methods Through comparison of the charge system of drug administrative registration of U. S. and that of China, the enlightenment of Prescription Drug User Fee Act （PDUFA） to our nation was expounded, and the relative reform measures of the drug registration supervision in China were discussed. Results and Conclusion The U. S. PDUFA could be a valuable reference to China for the reform of drug registration approval system.

关 键 词：药品审批 药品审评 美国处方药使用者收费法案 行政付费 

分 类 号：R95[医药卫生—药学]