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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”).
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).
April 6, 2020, Covington Alert
This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...
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.