For the registration of drugs in China, the following contents should be provided.

(1) Summary

1. Drug name

2. Supporting documents

   2.1 Supporting documents of registration classification 4

   2.2 Supporting documents of registration classification 5.2

3. Purpose and basis of the study

4. Self-assessment report

5. Information on Marketing Authorization Holder

6. Information on originator drug

7. Drug package inserts, drafting instructions and related references

8. Packaging and label design styles

(2) Drug

11. （2.3.P）Pharmacology summary

12.（3.2.P）Application materials

12.1.（3.2.P.1）Dosage form and composition of the Drug

12.2.（3.2.P.2）Pharmaceutical development

12.3.（3.2.P.3）Manufacture

12.4.（3.2.P.4）Control of excipients

12.5.（3.2.P.5）Control of Drug

12.6.（3.2.P.6）Reference Standards or Materials

12.7.（3.2.P.7）Stability

13.（2.4.P）Nonclinical tabulated summaries

14. Nonclinical study tabulated summary

14.1.（4.2.2）Pharmacokinetics tabulated summary

14.2．（4.2.3）Toxicology tabulated summary

15. （2.5.P.）Clinial study tabulated summary

16. Application materials of Clinical studies

16.1.（5.2） Tabular listing of all clinical studies

16.2.（5.3）Bioequivalence (BE) Study Reports

16.2.1.（5.3.1.2.1）Bioequivalence (BE) Study Reports before a meal

16.2.2.（5.3.1.2.2）Bioequivalence (BE) Study Reports after a meal

16.2.3.(5.3.1.4) Reports of Bioanalytical and Analytical Methods

16.3.（5.3.5.4）Other clinical studies reports

16.4.（5.4）Literature references