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.