CFDA Releases Groundbreaking Drug and Device Policies for Public Comment

CFDA Releases Groundbreaking Drug and Device Policies for Public Comment

May 23, 2017, Covington Alert

On May 11 and 12, 2017, the China Food and Drug Administration (“CFDA”) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These “Proposed Policies” include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle management and post-marketing surveillance (“Circular 54”), and regulatory data protection and patent linkage (“Circular 55”). Comments for each circular are due on June 10, 2017, but CFDA recommends that the comments be submitted by email before May 25, 2017.