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- Key Takeaways from China's Regulation on the Administration of Human Genetic Resources
Key Takeaways from China's Regulation on the Administration of Human Genetic Resources
June 18, 2019, Covington Alert
On June 10, 2019, the State Council (China’s chief executive agency) promulgated the long-awaited Regulation on the Administration of Human Genetic Resources (the “Regulation”), which will become effective on July 1, 2019. The Regulation supersedes the currently effective regulations and guidance on human genetic resources (“HGR”).
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.
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 ...
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 ...