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China CFDA registration application documents for Class 5.2 Imported Generic 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. Drug Substance (API)

9. (2.3.S, Note: Figures in bracket are numbers in CTD format, the same below) Summary of Pharmaceutical Study Information of Drug Substance (API)
10.(3.2.S)Pharmaceutical Applification Files of Drug Substance (API)
10.1(3.2.S.1)General Information
10.2(3.2.S.2)Manufacture
10.3.(3.2.S.3)Characterization
10.4.(3.2.S.4)Control of Drug Substance
10.5.(3.2.S.5)Reference Standards
10.6.(3.2.S.6)Container Clouser System
10.7.(3.2.S.7)Stability

C. Drug Product

11. (2.3.P)Summary of Pharmaceutical Study Information of Drug Product
12.(3.2.P)Pharmaceutical Applification Files of Drug Product
12.1.(3.2.P.1)Description and Composition of the Drug Product
12.2.(3.2.P.2)Pharmaceutical Development
12.3.(3.2.P.3)Manufacturer
12.4.(3.2.P.4)Control of Expients
12.5.(3.2.P.5)Control of Drug Product
12.6.(3.2.P.6)Reference Standards
12.7.(3.2.P.7)Stability
13.(2.4.P)Summary of Nonclinical Study Information of Drug Product
14. Summary of Nonclinical Applification Files of Drug Product
14.1.(4.2.2)Pharmacokinetics
14.2(4.2.3)Toxicology
15. (2.5.P.)Summary of Clinical Study Information of Drug Product
16. Summary of Clinical Applification Files of Drug Product
16.1.(5.2)Summary of Clinical Trial Items
16.2.(5.3)Bioequivalence Test Report
16.2.1.(5.3.1.2.1)Fasting Bioequivalence Test Report
16.2.2.(5.3.1.2.2)Postprandial Bioequivalence Test Report
16.2.3.(5.3.1.4) Report of Method Validation and Biological Sample Analysis
16.3.(5.3.5.4)Other clinical trial reports
16.4.(5.4)References

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