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2013 Chinese Pharmaceutical Guidebook: Drug Registration Rules
Date:4/10/2013

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 @ http://www.marketreportsonline.com/contacts/Purchase.aspx?name=232497 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
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