I) Summary

1. Drug name

2. Certified document

Certified document of class 5.1 product by register classification

3. Purpose and basis of subject selection

4. Self-assessment report

5. Listed Licensee information

6. Innovator product information

7. Package insert, drafting Instruction and related references

8. Design comps of product packaging and label

II) Main Summary of Pharmaceutical Study Information

9. Summary of Pharmaceutical Study Information

10. Summary of Non-clinical Study Informatioon

11. Summary of Clinical Study Information

III) Pharmaceutical Study information

12. (3.2.S, Note: Figures in bracket are numbers in CTD format, the same below) Drug Substance (API)

12.1. (3.2.S.1) General Information

12.2. (3.2.S.2) Manufacture Information

12.3. (3.2.S.3) Characterization

12.4. (3.2.S.4) Control of Drug Substance

12.5. (3.2.S.5) Reference Standards

12.6. (3.2.5.6) Container Clouser System

12.7. (3.2.5.7) Stability

13. (3.2.P) Drug Product

13.1. (3.2.P.1) Description and Composition of the Drug Product

13.2. (3.2.P.2) Pharmaceutical Development

13.3. (3.2.P.3) Manufacturer

13.4. (3.2.P.4) Control of Expients

13.5. (3.2.P.5) Control of Drug Product

13.6. (3.2.P.6) Reference Standard

13.7 (3.2.P.7) Stability

IV) Non-clinical Study Information

14. Summary of nonclinical studies

15. The main pharmacodynamic test data and literature

16. Safety pharmacology test data and literature

17. Single administration toxicity test data and literature

18. Repeated administration toxicity test data and literature

19. Genotoxicity test data and literature

20. Reproductive toxicity test data and literature

21. Carcinogenic test data and literature

22. Dependency test data and liter

23. Allergy (local, systemic and phototoxic), hemolytic and local (vascular, skin, mucous membrane, muscle, etc.) irritation

and other special safety test data and literature

24. Other safety test data and literature

25. Non-clinical pharmacokinetic test data and literatu

26. The interaction experimental data on the efficacy, toxicity and pharmacokinetics between the variety ingredients in the compound preparation, and its literature

V) Clinical trial data

27. Clinical trials summary data

28. Clinical trial plans and protocols

29. Data management plan, statistical analysis plan

30. Clinical l trial research manual

31. Samples of informed consent and ethics approval; scientific committee review report

32. Clinical trial report

Clinical trial databases electronic documents (raw databases, derived analytical databases and its variable explanatory documents)

34. Data management reports and statistical analysis reports