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

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.