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