Pharmaceutical Regulation in China

This chapter explores China’s growth as a regulator of innovative medicines, both small molecule (chemical) drugs and biologics. It examines regulation over the life cycle of a drug, from development to the post-marketing environment. From 2015 to 2023, China has taken steps to transform itself from a generic drug market to an innovative one, where the latest medicines are available. To facilitate this change, it has tried to harmonize its drug regulatory system with international standards in many respects, but significant differences and some serious challenges remain.