第二部分

注册分类4、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 System 10.7.（3.2.S.7）稳定性Stability （三）制剂Drug Product

11. （2.3.P） 制剂药学研究信息汇总表。Summary of Pharmaceutical Study Information of Drug Product

12.（3.2.P）制剂药学申报资料。Pharmaceutical Applification Files of Drug Product

12.1.（3.2.P.1）剂型及产品组成Description and Composition of the Drug Product

12.2.（3.2.P.2）产品开发Pharmaceutical Development 12.3.（3.2.P.3）生产信息Manufacturer

12.4.（3.2.P.4）原辅料的控制Control of Expients 12.5.（3.2.P.5）制剂的质量控制Control of Drug Product 12.6.（3.2.P.6）对照品Reference Standards 12.7.（3.2.P.7）稳定性Stability

13.（2.4.P）制剂非临床研究信息汇总表。Summary of Nonclinical Study Information of Drug Product

14. 制剂非临床研究申报资料。Summary of Nonclinical Applification Files of Drug Product

14.1.（4.2.2）药代动力学Pharmacokinetics 14.2．（4.2.3）毒理学Toxicology

15. （2.5.P.）制剂临床试验信息汇总表。Summary of Clinical Study Information of Drug Product

16.制剂临床试验申报资料。Summary of Clinical Applification Files of Drug Product

16.1.（5.2） 临床试验项目汇总表Summary of Clinical Trial Items 16.2.（5.3）生物等效性试验报告Bioequivalence Test Report

16.2.1.（5.3.1.2.1）空腹生物等效性试验报告Fasting Bioequivalence Test Report

16.2.2.（5.3.1.2.2）餐后生物等效性试验报告Postprandial Bioequivalence Test Report

16.2.3.(5.3.1.4) 方法学验证及生物样品分析报告Report of Method Validation and Biological Sample Analysis

16.3.（5.3.5.4）其他临床试验报告Other clinical trial reports 16.4.（5.4）参考文献References