OBJECTIVE  To study the construction and change of China's generic drug review and approval system since the introduction of the Drug Administration Law of the People's Republic of China(hereinafter referred to as the Drug Administration Law), to understand the development transition and operation of China's generic drug industry, and to think about how to guarantee the continued high-quality development of the generic drug industry.

METHODS Accessed to literature and official national websites for relevant policy information, industry views and detailed data.

RESULTS According to the formulation and revision of the Drug Administration Law and the proposal of consistency evaluation, the history of the construction of generic drug review and approval could be divided into 4 stages. The continuous development of the generic drug review and approval system had boosted China's generic drug industry into an era of high-quality development, with breakthroughs in high-barrier generic drugs and accelerated internationalization.

CONCLUSION  With the gradual improvement of the legal system for the regulation of generic drugs centered on the Drug Administration Law, the connotation of generic drugs has transitioned from imitation standard to imitation original research, and the review and approval system has developed simultaneously. However, there are problems such as low-level duplication of generic drugs in China, for this reason, China should optimize the review and approval mechanism of generic drugs, and help the continuous and high-quality development of generic drugs.