The evolution of China’s genomic data protections: honing a blunt instrument

The latest update to China’s genomic data policies, which go into effect July 1, show regulators are course correcting toward more practical guidelines that decrease burdens for foreign clinical trial sponsors by limiting the types of studies requiring governmental review. 

Since the 1998 launch of a rule requiring government approval for foreign entities to access genetic data from Chinese citizens, cross-border biomedical research has come with additional scrutiny and legwork. Chinese government communications and crackdowns around the rules in the 2010s, amid geopolitical tensions between the U.S. and China, created uncertainty about whether these policies would grow more restrictive, or adapt to better support the country’s expanding role in the biopharma ecosystem (see Figure)...