CFDA Seeks to Remove Some Barriers to Foreign Drug Entry into China

CFDA Seeks to Remove Some Barriers to Foreign Drug Entry into China

April 7, 2017, Covington Alert

On March 17, 2017, the China Food and Drug Administration (“CFDA”) released a notice to seek public comments on four proposed adjustments to China’s drug registration requirements (“Proposed Adjustments”) that will remove some barriers to applications for clinical trials and drug registrations of imported drugs (drugs that are manufactured outside of China). The Proposed Adjustments could substantially impact the strategies for bringing imported drugs to China. Imported drug manufacturers should understand the potential impact of the Proposed Adjustments, consider submitting comments, and closely monitor future developments in this area. Comments are due on April 20, 2017.