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China Generic Drug Registrations Nose Dive

This article was originally published in PharmAsia News

Executive Summary

According to recent China State FDA figures, since the revised drug registration rule took effect last October, applications for generic drug registrations have nose dived while applications for new drugs have grown. During this one-year period, China has accepted applications of 553 new drugs, 155 formulation changes, 825 generic drugs, 502 imported drugs and 225 biological products. The generics figure contrasts sharply with the over 8,000 approved in 2005. SFDA officials think the trend indicates that new policies have held in check applications based on copying or modifying drugs with low R&D technology. The agency will publicize at the end of this year new drug applications approved since last October. (Click here for more - Chinese Language)
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