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- 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.
March 27, 2018, Covington Alert
China has reorganized many of the ministries and commissions under its chief executive body, the State Council, creating a new super-ministry to replace the China Food and Drug Administration (“CFDA”) and other healthcare agencies.
November 6, 2017, Covington Alert
China has recently announced several initiatives to reform its regulation of drugs and medical devices that could have a significant impact on pharmaceutical and medical device companies doing business in China.
January 23, 2017, Covington Alert
On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from ...