A Comprehensive Guidebook for Foreign Pharmaceutical Companies Industry 2015 Research Report

This is the first guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the latest Chinese regulations for imported drug registration, and guide overseas pharmaceutical manufacturers and producers to file the application for their imported drugs with the Chinese pharmaceutical authorities.

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Summary

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion)

Table Of Content

Chapter 1. Introduction.5

Chapter 2. The State Food and Drug Administration in China.6

2.1. SFDAs Main Responsibilities.6

2.2. SFDAs Organizational Structure..7

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Chapter 3. General Regulations on Application and Approval for Imported Drug Registration.13

3.1. Classification of Drugs..13

3.2. Definitions.13

3.3. General Regulations on Application and Approval for Imported Drug Registration.17

3.3.1. Application and Approval for Imported Drugs.17

3.3.2. Application and Approval for Repackaging of Imported Drug.21

3.3.3. Supplementary Application..23

3.3.4. Re-registration..24

3.3.5. Clinical Trials.26

3.3.6. Time Limits in Drug Registration30

Chapter 4. Application and Approval Procedures for Imported Drug Registration..33

4.1. Application and Approval Procedure for Imported Drugs33

4.2.Supplementary Application and Approval Procedure for Imported Drugs..35

4.3.Application and Approval Procedure for Clinical Trials.37

Chapter 5. Application Form for Imported Drug Registration.39

Chapter 6. Conclusion..44

Chapter 7. Appendices46

7.1. The Drug Administration Law of the Peoples Republic of China..46

7.2. The Regulations for Implementation of the Drug...