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China’s SFDA to Shorten IND Wait for Innovative Drugs

publication date: May 9, 2008

The SFDA will soon introduce new rules that will speed up the IND process for innovative drugs in China. The new procedures will not, apparently, change overall IND standards. However, the SFDA will establish guidelines that distinguish innovative drugs, especially those for unmet needs, from less significant submissions. These innovative INDs will receive first priority at the SFDA and result in a speedier ruling, though the SFDA did not declare a specific target for IND turnaround time. More details...



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