On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment:
(1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval Guidance“); and...
(2) Compassionate Use of Clinical Trial Drugs Administrative Measures (the “Draft Compassionate Use Measures” and, together with the Draft Conditional Approval Guidance, the “Draft CFDA Documents“).
Please see full publication below for more information.