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China Enacts Biosecurity Law
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 of drug and device products. The Law addresses a number of different areas, from bioterrorism to the regulation of plant, animal, and human specimens, and may bring new risks for life sciences companies to consider with respect to their development plans in China. Implementing regulations, which could be issued over the next five months, should help clarify the Law’s impact.
This alert summarizes the key features of the Law.
January 25, 2021
By: Muyun Hu On December 25, 2020, the Institute of Food Science and Technology (“IFST”) issued China’s first plant-based meat standard T/CIFST 001-2020 (the “Standard”). The Standard will take effect on June 25, 2021. The Standard is a group standard issued by a government sponsored industry association and adopted by its members.[1] Group standards can ...
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.