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Published Date: April 10 2013
Page Count: 117
Unit Price: US$ 750
Site License: US$3500
Global Site License:US$5250
Format: Electronic PDF copy
Publisher:Access China Management Consulting Ltd



China Pharmaceutical Guidebook Series (1) (2013 edition)
Latest Chinese Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies
Summary Table of contents
Table of Contents.1
Preface.2
Chapter 1. Introduction.5
Chapter 2. The State Food and Drug Administration in China.6
2.1. CFDAs Main Responsibilities.6
2.2. CFDAs Organizational Structure..7
Figure 2.2.1. CFDAs Organizational Structure.8
Table 2.2.1. CFDAs affiliated organizations.9
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 Registration.30
Chapter 4. Application and Approval Procedures for Imported Drug Registration..33
4.1. Application and Approval Procedure for Imported Drugs.33
Figure 4.1.1. Application and Approval Procedure for Imported Drugs (1)34
Figure 4.1.2. Application and Approval Procedure for Imported Drugs (2)35
4.2.Supplementary Application and Approval Procedure for Imported Drugs.35
Figure 4.2.1. Supplementary Application and Approval Procedure for Imported Drugs(1).36
Figure 4.2.2. Supplementary Application and Approval Procedure for Imported Drugs (2).37
4.3.Application and Approval Procedure for Clinical Trials.37
Figure 4.3.1. Application and Approval Procedure for Clinical Trials..38
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 Administration Law of the Peoples Republic of China..71
7.3. The Good Clinical Practice of Pharmaceutical Products.95
7.4. References.115
7.5. Companys Description.116

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