Course Outlines

MODULE 1: Regional Administrative Information

• Definition and description of Module 1
• Requirements of M1 (Tables of contents)
• Application of Product file.
• Product Information.
• Pharmacovigilance System.
• Certificates and Pricing

MODULE 2: Common Technical Document Summaries

• Definition and description of Module 2
• Requirements of M2 (Tables of contents)
• Quality Overall Summary
• Nonclinical Overview
• Clinical Overview
• Non-Clinical Written and Tabulated Summaries
• Clinical Summary

MODULE 3: Quality

• Definition and description of Module 3
• Requirements of M3 (Tables of contents)
• Drug Substance
• Drug Product
• Appendices and Regional Information
• Frequently SFDA Comments on M3
• Check list by SFDA 

MODULE 4: Non-Clinical Study Reports

• Definition and description of Module 4
• Requirements of M4 (Tables of contents)
• Pharmacology (PK/PD)
• Toxicology
• Genotoxicity and Carcinogenicity
• Non-clinical summary and tabulate summaries

MODULE 5: Clinical Study Reports

• Definition and description of Module 5
• Requirements of M5 (Tables of contents)
• Clinical Data Requirements.
• Bioequivalence
• Reports of Post-Marketing Experience