Generic drugs could not only improve the accessibility of drugs，but also significantly reduce the cost of drugs. However，the development，production and regulation of generic drugs were as challenging as those of new drugs. Although China was a major producer of chemical generic drugs，it was far from being a strong producer of chemical generic drugs. In order to help people obtain safe，effective and high-quality medicines at more reasonable prices，improving the regulation of generic drugs and reforming the supply-side structure of the generic drug industry had become an important task of China’s drug regulatory authorities during the 13th Five-Year period. The US FDA’s drug registration and regulatory system had a history of more than 100 years and was authoritative worldwide. Therefore，we need to systematically study and analyze the experience of generic drug management in the U.S.，which would provide reference for us to deepen the reform of the review and approval system for generic drugs.