China's FDA Reform Will Encourage Life Science Innovation

Law360, New York (November 15, 2017, 2:11 PM EST) -- The China Food and Drug Administration Office (CFDA) continues to reform the current review and approval system for drugs and devices, according to a circular entitled the Opinions Regarding Strengthening the Review and Approval System Reform to Encourage Innovation of Drugs and Medical Devices (opinions). The opinions outline a series of robust reform initiatives, and reflect the Chinese government’s unprecedented determination to accelerate drug and device approvals and encourage innovation.

The opinions were finalized based on four draft reform proposals issued by the CFDA this May. Compared with the CFDA's draft proposals, the opinions introduce a few new initiatives: a pilot...

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