January 17, 2018

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

Aldo Boni de Nobili, Andrew McGinty, Jun Wei, Jessie Xie, Roy Zou

Hogan Lovells

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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“).

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.