请问5.2类进口药品注册，是走正常临床还是做BE呢?5.2类申报资料要求(试行) 一、申报资料项目Application File Item （一）概要Summary 1.药品名称。Drug name 2.证明性文件。Certified document 2.1注册分类4类证明性文件 Certified document of class 4 product by register classification. 2.2注册分类5.2类证明性文件Certified document of class 5.2 product by register classification. 3.立题目的与依据。Purpose and basis of subject selection 4.自评估报告。Self-assessment report 5.上市许可人信息。Listed Licensee information 6. 原研药品信息。Innovator product information 7.药品说明书、起草说明及相关参考文献。Package insert, drafting Instruction and related references 8.包装、标签设计样稿。Design comps of product packaging and label. （二）原料药Drug Substance (API) 9.（2.3.S,注:括号内为CTD格式的编号，以下同）原料药药学研究信息汇总表。(2.3.S, Note: Figures in bracket are numbers in CTD format, the same below) Summary of Pharmaceutical Study Information of Drug Substance (API) 10.（3.2.S）原料药药学申报资料。Pharmaceutical Applification Files of Drug Substance (API) 10.1．（3.2.S.1）基本信息General Information 10.2．（3.2.S.2）生产信息Manufacture 10.3.（3.2.S.3）特性鉴定Characterization 10.4.（3.2.S.4）原料药的质量控制Control of Drug Substance 10.5.（3.2.S.5）对照品Reference Standards 10.6.（3.2.S.6）包装材料和容器Container Clouser System10.7.（3.2.S.7）稳定性Stability查看更多
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