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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