Chinese Pharmaceutical Guidebook Series

Table of Contents

Preface
Chapter 1. Introduction
Chapter 2.The State Food and Drug Administration in China
2.1. SFDA’s Main Responsibilities
2.2. SFDA’s Organization Structure

Chapter 3.General Regulations on Application and Approval for Imported Drug Registration
3.1. Classification of Drugs
3.2. Definitions
3.3. General Regulations on Application and Approval for Imported Drug Registration
3.3.1. Application and Approval for Imported Drug
3.3.2. Application and Approval for Repackaging of Imported Drug
3.3.3. Supplementary Application
3.3.4. Re-registration
3.3.5.Clinical Investigation
3.3.5.1.Preclinical investigation
3.3.5.2.Clinical Trials
3.3.6. Time Limits in Drug Registration

Chapter 4. Application and Approval Procedures for Imported Drug Registration
4.1.Application and Approval Procedure for Imported Drugs
4.2.Supplementary Application and Approval Procedure for Imported Drugs
4.3.Application and Approval Procedure for Clinical Trials

Chapter 5. Conclusion
Chapter 6. Appendices
6.1. References
6.2. Resources
6.3. Author’s Biography
6.4. Company’s Description