美国《处方药申报者付费法案(PDUFA)》对FDA缩短新药审评时间的影响  

Impact of Prescription Drug User Free Act (PDUFA) of FDA of the United States of America on Reduction of Duration of Examination and Approval of New Drugs

作　　者：郭治昕[1] 赵利斌[1] 元英进[2] 

机构地区：[1]天津天士力集团公司研究院,天津300402 [2]天津大学化工学院,天津300072

出　　处：《世界科学技术-中医药现代化》2005年第5期74-80,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：天津天士力集团科研课题:中药进入美国市场的研究

摘　　要：美国是世界上最大的药品市场,对各国制药企业充满着诱惑。中国作为世界上的制药大国(还谈不上制药强国),医药产品要想进入美国市场销售,必须通过美国FDA的严格审评。因此,充分了解FDA对药品审评过程中的药政管理和法规,对国内制药企业在美国的药品申报具有重要意义。本文从工作实践的角度简述了《处方药申报者会费法案,PDUFA》的出台背景及内容,期望对国内制药企业的美国申报有所帮助和启发。The United States of America is the biggest consuming country of drugs in the whole world and this fact brings out full temptation to pharmaceutical enterprises of other countries in the world. Although China is already a big country (not a powerful one though) in the production of drugs, its medicinal products cannot enter into U.S. drug market unless they go through strict examination and approval of FDA. Therefore it is of great significance to thoroughly know the administration and the rules and regulations of FDA's examination and approval of drugs so that Chinese pharmaceutical enterprises can more conveniently make application for their products to enter into the U.S.

关 键 词：美国FDA 新药申请 处方药申报者付费法案 PDUFA费用 审评时间 批准时间 美国FDA 药品申报 新药审评 处方药 制药企业 时间 缩短 付费 药品市场 

分 类 号：R95[医药卫生—药学] R951