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  4. > China Pharmaceutical Guidebook Series (1) 2013 Edition - Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies

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) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities. 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 and thorough 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. In despite of since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and become increasingly compatible with international standards, in turn, its ongoing consolidation will eventually contribute to a healthier market environment. The Chinese Pharmaceutical authority promulgated the last “Measures for the Administration of Drug Registration” on July 10 2007, and the last “Measures” entered into force since October 1, 2007. However, the practical operations for application and approval of imported drug registration have been constantly changed, because the amendment of “Measures” is delayed. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series: 2013 Edition. The aim of this guidebook series is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook series are composed of four guidebooks as the following.

- Latest Chinese Regulations for Imported Drug Registration: 2013 Edition
A Comprehensive Guidebook for Foreign Pharmaceutical Companies

- Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition
A Guidebook for Application of Imported Chemical Drugs Registration

- Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition
A Guidebook for Application of Imported Biological Product Registration

- Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition
A Guidebook for Application of Imported Traditional Chinese Medicine and Natural Medicine Registration

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. Chapter 2 provides an overview of the main responsibilities and organizational structure of the State Food and Drug Administration (hereinafter called as 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. Chapter 5 provides an English version of Application Form for Imported Drug Registration in order to facilitate overseas audience to easily file the application of imported drug registration with the SFDA. The guidebook concludes in chapter 6 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 7 include the Drug Administration Law of the People’s Republic of China, the Regulations for Implementation of Drug Administration Law of the People’s Republic of China, and the Chinese Good Clinical Practice of Pharmaceutical Products. 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.
- An English version of Application Form for Imported Drug Registration in order to facilitate overseas audience to easily file the application of imported drug registration with the SFDA.
- 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, and so on.

Table Of Contents

China Pharmaceutical Guidebook Series (1) 2013 Edition - Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies
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. SFDA's Main Responsibilities.6
2.2. SFDA's Organizational Structure..7
Figure 2.2.1. SFDA's Organizational Structure.8
Table 2.2.1. SFDA's 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. Appendices…46
7.1. The Drug Administration Law of the People's Republic of China..46
7.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China..71
7.3. The Good Clinical Practice of Pharmaceutical Products…95
7.4. References….115
7.5. Company's Description…116

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