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中国药学会上海分会和上海医科大学药学院于1999年7月6日在市科协联合召开新药研究的国际标准化学术报告会,由美国FDA的赵洪博士主讲。据她介绍,新药研究的国际标准化问题,是全世界关注的问题。新药研究的标准全世界统一了,各国上市的新药就可彼此认可,这样就可以节省时间、节省费用。 过去FDA审批一个新药,要花很多时间,审批周期很长。自1992年开始,FDA审批新药实行收费制。新药研究公司可通过FDA召开一系列围绕新药研究
Chinese Pharmaceutical Association Shanghai Branch and Shanghai Medical University School of Pharmacy in July 6, 1999 jointly held in the City Association for the study of new drug international standardization academic report by the FDA Dr. Zhao Hong speaker. According to her, the international standardization of new drug research is a matter of worldwide concern. The standards of new drug research are unified all over the world, and new drugs listed in various countries can recognize each other, so that time can be saved and costs can be saved. FDA approved a new drug in the past, it takes a lot of time, approval cycle is very long. Since 1992, FDA approved the implementation of new drug fee system. New drug research company through the FDA held a series of new drug research