China CFDA registration application documents for Class 5.1 Imported Innovative Drugs (2016 version)

A. Summary

1.Drug name
2.Certified document
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
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.

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> 12.2．(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
1212.6.(3.2.S.6)Container Clouser System
12.7.(3.2.S.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 Standards
13.7.(3.2.P.7)Stability

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 report.
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.