China Drug Approval Process

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] Following an announcement by China’s State Council in August on its intention to speed up drug and device approvals in China (IPQ “Monthly Update” July/Aug. 2015, p. 51) the China Food and Drug Administration (CFDA) has published its implementation plans, Ropes & Gray is reporting.  The plans are contained in the November 11, 2015 release of the “Circular Concerning Several Policies on Drug Registration Review and Approval (CFDA Circular [2015] No. 230) and several draft implementation measures. These documents aim to transform China’s drug approval system by implementing the following initiatives: ● piloting the European Marketing Authorization Holder (MAH) system ● expanding the fast track approval pathway ● changing the classifications for new drugs and generics, and ● simplifying the approval process for clinical trials.  Of note is the policy change that categorizes a new drug as one that has not been approved anywhere in the world, as opposed to the current definition of not yet approved in China.  While the new definition, which goes into effect on December 1, applies primarily to new applications, sponsors with applications in process that meet the definition can apply for expedited approval, Biocentury is reporting.

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