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China Launches New Product Pathways in Hainan Special Zone
March 4, 2019, Covington Alert
On December 29, 2018, the State Council (China’s chief executive agency) opened a new pathway for drugs to come into China through a special zone in southern China. It suspended certain central regulations in the Bo Ao Lecheng International Medical Tourism Pilot Zone in Hainan Province (“Pilot Zone”) and permitted local authorities to make marketing decisions for the Pilot Zone, pursuant to the “Decision of the State Council on Tentatively Adjusting the Implementation of the ‘Regulations on the Implementation of the Drug Administration Law’ in the Bo Ao Lecheng International Medical Tourism Pilot Zone, Hainan Province” (“Drug Decision”).
September 9, 2019, Covington Alert
On August 26, 2019, China’s Standing Committee of National People's Congress (“NPC) adopted a significant revision of the Drug Administration Law (“DAL”). The newly adopted DAL (“Revised DAL”) will go into effect on December 1, 2019. The Revised DAL is the first overhaul of the DAL since 2001.
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.
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 ...