I. Items of application documents

(I) Summary

1. Name of the drug

2. Certificates

2.1 certificates required for category 4

2.2 certificates required for category 5.2

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) API

9.(2.3.S, note: number in bracket is number of CTD format, the same as below ) pharmaceutical study information summary sheet of API

10.(3.2.S) Pharmaceutical application documents of API

10.1.(3.2.S.1) General information

10.2.(3.2.S.2)manufacturing information

10.3.(3.2.S.3)Characterization

10.4.(3.2.S.4)Quality control of API

10.5.(3.2.S.5)Reference materials

10.6.(3.2.S.6)Packing material and container

10.7.(3.2.S.7)Stability

(III) Drug products

11.(2.3.P)Pharmaceutical study information summary sheet of drug product

12.(3.2.P) Pharmaceutical application documents of drug product

12.1.(3.2.P.1)dosage form and composition of product

12.2.(3.2.P.2)Development of product

12.3.(3.2.P.3)Manufacturing information

12.4.(3.2.P.4)Control of materials

12.5.(3.2.P.5)Quality control of drug product

12.6.(3.2.P.6)Reference materials

12.7.(3.2.P.7)Stability

13.(2.4.P) Non-clinical study information summary sheet of drug product

14. Non-clinical study application documents of drug product

 14.1.(4.2.2) Pharmacokinetics

 14.2.(4.2.3)Toxicology

15.(2.5.P)Clinical trials information summary sheet of drug product

16. Clinical trials application documents of drug product

 16.1.(5.2) Clinical trials items summary sheet

 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) Bioequivalence test report after the meal

  16.2.3.(5.3.1.4) Methodology validation and biological sample analytical report

16.3.(5.3.5.4) Other clinical trials report

16.4.(5.4) Bibliography