The Chinese Food and Drug Administration ("CFDA") recently published a draft circular to address the more than 21,000 drug applications that have been submitted for agency review (CFDA Circular [2015] No. 140, the "No. 140 Circular"). The No. 140 Circular proposes 10 policies to reduce the backlog of drug applications and expedite the approval process for certain types of drugs. The policy also proposes changing the approval system for bioequivalence studies. The No. 140 Circular comes in response to criticism from China's State Council, which instructed the CFDA's Center for Drug Evaluation that the current backlog must not grow larger in the next year and the entire backlog must be addressed by 2018. In parallel, the CFDA has also posted a notice seeking to recruit an additional 69 people to review drug approval submissions, which would increase the division's staff by approximately 50 percent.

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