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Registration of imported drugs

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.PPharmacology summary

12.3.2.PApplication materials form and composition of the Drug development of excipients of Drug Standards or Materials

13.2.4.PNonclinical tabulated summaries

14. Nonclinical study tabulated summary tabulated summary

14.2.(4.2.3Toxicology tabulated summary

15. 2.5.P.Clinial study tabulated summary

16. Application materials of Clinical studies listing of all clinical studies (BE) Study Reports (BE) Study Reports before a meal (BE) Study Reports after a meal

16.2.3.( Reports of Bioanalytical and Analytical Methods clinical studies reports references

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