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SFDA Activates Special Procedures For Flu Vaccine Approval

This article was originally published in PharmAsia News

Executive Summary

China's State FDA is putting in place special approval procedures to stockpile pandemic influenza vaccine before the Beijing Olympic Games opening. This is the first time that the country will enforce the procedure drawn up in 2005 to address emergency public health threats. Considering the supply urgency and the complexity of pandemic influenza vaccine R&D, SFDA is adopting an early intervention approach toward vaccine development. It has commenced approval procedures for the flu vaccine produced by Beijing Sinovac Biotech, and will complete the technical evaluation in the shortest possible time. The agency will then decide whether to issue the authorization certificate and drug approval number within three days. To date, Sinovac has finished Phase II clinical trial of its vaccine. (Click here for more - Chinese Language)

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