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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”).
December 9, 2020, Covington Alert
On October 17, 2020, the Standing Committee of National People's Congress (“NPCSC”), China’s top legislative body, adopted a Biosecurity Law (“Law”), which will go into effect on April 15, 2021. The Law reflects a growing area of regulation of drugs and medical devices in China that is separate from the regulations to ensure safety, effectiveness, and quality ...
April 29, 2020, Covington Alert
On March 30, 2020, the State Administration of Market Regulation of China, the parent agency of the National Medical Products Administration (NMPA), released a revised Drug Registration Regulation (Revised DRR).
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.