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Shortened IND Approvals for Oncology Drugs

Sep. 1, 2015

The CFDA is expected to expedite IND approvals for drugs.

Under the current situation, companies have to wait 18-24 months before they are allowed to commence clinical trials on new drugs. According to the new regulations decisions will have to be made within 60 days.

The pilot program will be implemented initially on oncology drugs only and will be expanded to include additional indications subject to its successful implementation.