(一)Summary Information (综述资料)
1、name of drug 药品名称
2. Certificate files (证明性文件)
Certificate of permission for marketing by the country or region drug authority(出口国药品主管当局允许上市销售的证明文件)
Certificate of GMP for Pharmaceutical Products (The Originals; The duplicates need notarial certification(药品GMP证明文件(原件，如果是复印件，则需要提供公证文件)。
2 . The real labels of drug for marketing(上市国上市销售的药品包装标签实样，最好提供)
(二)Pharmaceutical Research files(药学研究资料)
7. Summary of Pharmaceutical Research Material(药学研究资料综述)。
8. Research materials and reference materials of drug preparation techniques(制剂生产工艺的研究资料及文献资料);
10、Test materials and reference materials of quality research(质量研究工作的试验资料及文献资料。)
11、Specification of drug and its explanation(药品标准及起草说明)。
12、The Inspection Report of the Samples(样品的检验报告书)。
13、The source, specification and inspection report of the raw materials and excipients(原料药、辅料的来源及质量标准、检验报告书)。www.med126.com
14、Test materials and reference materials of stability research(药物稳定性研究的试验资料及文献资料)。
15、The selection basis and specification of primary packaging materials(直接接触药品的包装材料和容器的选择依据及质量标准)。
(三)Pharmacological and toxicological research materials(药理毒理研究资料)
16、Summary of pharmacological and toxicological research materials(药理毒理研究资料综述)。
17、Test materials and reference materials of main pharmacodynamics (主要药效学试验资料及文献资料)。
18、Test materials and reference materials of safety pharmacology studies for human pharmaceuticals (一般药理学的试验资料及文献资料)。
19、Test materials and reference materials of acute toxicity(急性毒性试验资料及文献资料)。
20、Test materials and reference materials of chronic toxicity(长期毒性试验资料及文献资料)。
23、Test materials and reference materials of mutagenicity(致突变试验资料及文献资料)。
24、Test materials and reference materials of germinal toxicity(生殖毒性试验资料及文献资料)。
25、Test materials and reference materials of carcinogenic(致癌试验资料及文献资料)。
27、Test materials and reference materials of animal dynamics(非临床药代动力学试验资料及文献资料)。
(四)Clinical research materials(临床试验资料)
28 Summary of domestic and foreign clinical study material(国内外相关的临床试验资料综述)。
