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 Chinese latest 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 Chinese latest regulations for imported drug registration, and guide overseas pharmaceutical manufacturers and producers to file the application for their drugs with the Chinese pharmaceutical authorities.
In this guidebook, chapter 2 provides an overview of the main responsibilities and organization structure of the 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 section 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. After have skimmed through this chapter, audience can be clearly aware of the Chinese latest regulations for imported 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 imported drug registration in China. The appendices in chapter 6 include references, a useful resources of URL, author¡¯s biography, and description of the publisher, Access China.
