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A Comprehensive Guidebook for Foreign Pharmaceutical Companies China Pharmaceutical Guidebook Series (1) (4th edition)

A Comprehensive Guidebook for Foreign Pharmaceutical Companies
China Pharmaceutical Guidebook Series (1)
(4th edition)

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Additional Information
Price $750.00
Meta Description In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exo
Publisher Access China
Date of Report Jan 5, 2011
Quick Overview
Executive Summary

In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Therefore, a comprehensive knowledge of the latest Chinese regulations for imported drug registration has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market. 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 drugs with the Chinese pharmaceutical authorities.

Chapter 2 provides an overview of the main responsibilities and organization structure of the State Food and Drug Administration (hereinafter called SFDA) that is current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration. The aim of this chapter is to give direction of gateway for application of imported drug registration. Chapter 3 addresses the comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration. Chapter 4 introduces the procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs. The guidebook concludes in chapter 5 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application of their drug registration in China. The appendices in chapter 6 include the Drug Administration Law of the People’s Republic of China, the Regulations for the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, references, a useful resources of URL, author’s biography, and description of Access China Management Consulting Ltd. After have skimmed through this guidebook, audience can be clearly aware of the latest Chinese regulations for application and approval of imported drug registration. For the detailed requirements of material items and clinical trial for application and approval of imported drug registration of various categories, such as chemical drugs, biological products, traditional Chinese medicines and natural medicines, audience can learn from various fascicles of the China Pharmaceutical Guidebook Series.

Report Highlights

? An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration.
? The comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration.
? The procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs.
? The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their pharmaceuticals registration in China.
? Many useful resources of law and regulations, including the Drug Administration Law of the People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.


Who should buy this report?
• Companies wishing to enter a lucrative drug market in China.
• Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration.
• Senior executive officers engaging regulatory and registration affairs for drugs.



Table of Contents
Table of Contents
Table of Contents 1
Preface 22
Chapter 1. Introduction 5
Chapter 2. The State Food and Drug Administration in China 6
2.1. SFDA’s Main Responsibilities 7
2.2. SFDA’s Organization Structure 9
Chapter 3. General Regulations on Application and Approval
for Imported Drug Registration 14
3.1. Classification of Drugs 14
3.2. Definitions 15
3.3. General Regulations on Application and Approval for Imported Drug
Registration 18
3.3.1. Application and Approval for Imported Drugs 18
3.3.2. Application and Approval for Repackaging of Imported Drug 23
3.3.3. Supplementary Application 25
3.3.4. Re-registration 26
3.3.5.Clinical Investigation 28
3.3.5.1.Preclinical investigation 28
3.3.5.2. Clinical Trials 29
3.3.6. Time Limits in Drug Registration 34
Chapter 4. Application and Approval Procedures for Imported Drug
Registration 38
4.1. Application and Approval Procedure for Imported Drugs 39
4.2.Supplementary Application and Approval Procedure for Imported
Drugs 41
4.3.Application and Approval Procedure for Clinical Trials 43
Chapter 5. Conclusion 45
Chapter 6. Appendices 48
6.1. The Drug Administration Law of the People’s Republic of China 48
6.2. The Regulations for Implementation of the Drug Administration
Law of the People’s Republic of China 75
6.3. The Good Clinical Practice of Pharmaceutical Products 102
6.4. The Good Manufacturing Practice for Pharmaceutical Products 124
6.5. Form of Registration Application for Imported Drug 143
6.6. References 148
6.7. Resources 149
6.8. Author’s Biography 151
6.9. Company’s Description 152






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