Summary
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 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.
Preface
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2004, sales on the Chinese drug market have reached $9.5 billion dollars, an increase of 3 fold over 1998 level. 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 of 20-25 percent per annum in next five years. China is expected to become the fifth largest drug market in the world by 2010.
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 2004, sales of imported drugs have shared over one fifth 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 to 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. The latest "Measures for the Administration of Drug Registration" have entered into force since May 1, 2005. These "Measures" provide detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd writes out the China Pharmaceutical Guidebook Series. 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:-
In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration.
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