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2013 Chinese Pharmaceutical Guidebook: Drug Registration Rules

DALLAS, April 10, 2013 /PRNewswire-iReach/ -- China Pharmaceutical Guidebook Series (1) 2013 Edition Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies

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.

For pharmaceutical companies planning to enter the Chinese drug market, Access China Management Consulting Ltd offers a guidebook series report "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. 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. 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. 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.

The first guidebook available for purchase @ 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. 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.

Comprehensive Table of Contents and more on the report can be explored @

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