2.1 Certified document of class 4 product by register classification.
2.2 Certified document of class 5.2 product by register classification.
3.Purpose and basis of subject selection
5. Listed Licensee information
6. Innovator product information
7. Package insert, drafting Instruction and related references
8. Design comps of product packaging and label.
B. Main Summary of Pharmaceutical Study Information
9. Summary of Pharmaceutical Study Information
10. Summary of Non-clinical Study Information
11. Summary of Clinical Study Information
C. 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 r>
12.4.(3.2.S.4)Control of Drug Substance
1212.6.(3.2.S.6)Container Clouser System
13.1.(3.2.P.1)Description and Composition of the Drug Product
13.4.(3.2.P.4)Control of Expients
13.5.(3.2.P.5)Control of Drug Product
D. 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.r>
21. Carcinogenic test data and literature.
22. Dependency test data and literature.
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 literature.
26. The interaction experimental data on the efficacy, toxicity and
pharmacokinetics between the variety ingredients in the compound preparation,
and its literature.
E. 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
32. clinical trial report.
33. clinical trial databases electronic documents (raw databases, derived
analytical databases and its variable explanatory documents).
34. data management reports and statistical analysis reports.