For the registration of APIs 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) Active Pharmaceutical Ingredients

9. Pharmacology summary

10.   （3.2.S）Application materials

    10.1.（3.2.S.1）General Information

    10.2.（3.2.S.2）Manufacture

    10.3.（3.2.S.3）Characterisation

    10.4.（3.2.S.4）Control of Drug Substance

    10.5.（3.2.S.5）Reference Standards or Materials

    10.6.（3.2.S.6）Container Closure System

    10.7.（3.2.S.7）Stability