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BIO 2011 International Convention

Small Staff At China's FDA Slows Regulatory Reviews

By Tom Wall


Tuesday, June 28, 2011
WASHINGTON – For Western biotechs, getting regulatory approval to market a drug in the emerging Chinese market won't just involve the challenges of navigating a process that's different from the U.S. FDA's. There's also the challenge in dealing with drug review capacity at China's State Food and Drug Administration (SFDA) and its Center for Drug Evaluation (CDE) that's a fraction of the FDA's.

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