Biosecurity and FDD Research and Development

Regulations treating human biospecimens and clinical data as a protected national resource have played an increasingly important role in drug and device development in China. China is gradually developing an area of law related to the security and protection against misuse of biotechnology: biosecurity. This area includes human, animal, and plant testing and research, as well as issues of bioterrorism. But the rules that have, to date, played the most prominent role in this area in China are the human genetic resource (HGR) regulations. This chapter examines the development of the area of biosecurity overall, with particular attention to the HGR regulatory regime.