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- 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.
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 ...