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CFDA to Start 60-Day Approvals for INDs of Oncology Drugs

publication date: Aug 27, 2015
The CFDA may soon have a plan for expedited IND approvals that would render a decision within 60 days. That would be a big change. Currently, companies must wait one to two years (or longer) before the agency rules on whether they can begin China clinical trials of a new drug. Several Asian countries -- Taiwan, Singapore and South Korea -- already have expedited approvals. China is drawing up plans for a pilot program for use with oncology drugs. Presumably, it will be put to wider use if the program works. More details....

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