关于我国化学药品技术指导原则体系有关问题的探讨

The situation and comments on the chemical drug guidelines of China

通过梳理目前国内外化学药品技术指导原则体系文件,分析了国内与欧美的差异和存在的问题,并从新药申报及审评角度分析了种种差异带来的误解和疑惑,同时结合实际工作经验提出了关于我国药品技术指导原则体系建设的思考和建议。

Based on analyzing the drug guidelines published by CFDA（ CDE）,FDA（ CDER） and EMA,the author points out some differences between those guidelines and the misunderstandings caused by those differences.Combined the actural work experience,the author gives some comments on the solution to the problems.