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.
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
