I. Items of application documents

(I) Summary

1. Name of the drug

2. Certificates

2.1 certificates required for category 1, 2, 3

2.2 certificates required for category 5.1

3. Purpose and basis of the project

4. Self-evaluation report

5. Information of the marketing authorization holder

6. Information of originator’s product

7. Package insert, drafting instruction and related bibliography

8. Sample manuscript of package and label

(II) Main study information summary sheet

9. pharmaceutical study information summary sheet

10. Non-clinical study information summary sheet

11. Clinical study information summary sheet

(III) Pharmaceutical study information

12.(3.2.S) API(Note: numbers in the brackets are No in CTD format)

12.1.(3.2.S.1) General information

12.2.(3.2.S.2)manufacturing information

12.3.(3.2.S.3)Characterization

12.4.(3.2.S.4)Quality control of API

12.5.(3.2.S.5)Reference materials

12.6.(3.2.S.6)Packing material and container

12.7.(3.2.S.7)Stability

13. (3.2.P)Drug products

13.1.(3.2.P.1)dosage form and composition of product

13.2.(3.2.P.2)Development of product

13.3.(3.2.P.3)Manufacturing information

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

13.5.(3.2.P.5)Quality control of drug product

13.6.(3.2.P.6)Reference materials

13.7.(3.2.P.7)Stability

(ⅳ) Non-clinical study information

14. Non-clinical study information

15. Primary Pharmacodynamic study information and literatures

16. Safety pharmacology study information and literatures

17. Single-dose toxicity study information and literatures

18. Multi-dose toxicity study information and literatures

19. Genetic toxicity study information and literatures

20. Reproductive toxicity study information and literatures

21. Carcinogenicity study information and literatures

22. Drug dependence study information and literatures

23. Special safety study information and literatures, such as Hypersensitivity (local, systemic and photosensitive toxicity), hemolytic and local (blood vessels, skin, mucous membrane, muscle, etc.) irritation etc.

24. Other safety study information and literatures

25. Non-clinical pharmacokinetics study information and literatures

26. Study information and literatures for interactions between the ingredients in compound preparation on efficacy, toxicity and pharmacokinetics

(ⅴ) Clinical trials information

27. Clinical trials summary information

28. Clinical trials plan and study protocol

29. Data management, statistical analysis plan

30. Clinical researchers manual

31. Informed consent form sample, ethics committee approval letter; Scientific committee review report

32. Clinical trials report

33. Clinical trials database electronic documents (original database, derived analysis database and its derived variable description file)

34. Data management reports, statistical analysis reports