Operation New Drugs: China Extends Fast Track System Beyond Cancer
Innovative new drugs in five categories are now eligible for fast track approvals in China, with the timescale shortened from 18 months normally to six months under the expanded system.
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Four dozen innovative new drugs are slated to be reviewed under China's fast-track system, including more than 20 products for rare diseases.
First comes the approval, then market access. A rapid regulatory clearance for BMS’s Opdivo in China not only pioneers a new and potentially huge market for immuno-oncology treatments, but may potentially set an example in how to expand market access for many new therapies waiting to get into the country, amid multiple recent regulatory and policy changes.