OBJECTIVE： To provide reference and suggestion for the development of the first generic drugs in China. METHODS： By the method of literature study， related system and regulations of the first generic drugs in the United States were introduced； according to the development and related systems of the first generic drugs in China， the problems about first generic drug system in China were pointed out. The improvement suggestions were put forward. RESULTS： In the United States， first generic drug system included a series of policies， legal system and complete supporting systems about R&D， registration， approval and purchase of first generic drugs， such as market exclusive system， orange book system， abbreviated new drug application system， first generic drug clinical trial data protection system， drug patent link system， and medical insurance generic drug replacement system； it sped up the distribution and application of the first generic drugs. At present， there were some policies and regulations about pricing， registration and approval； but there was no complete supporting system of the first generic drugs.CONCLUSIONS： The development of the first generic drugs can be promoted in China by referring to relatedmature supporting system of the first generic drugs in the United States， clarifying the definition of the first generic drugs， simplifying registration and approval procedure of the first generic drugs， establishing data protection system of the first generic drugs and guaranteeing the distribution and application of the first generic drugs from the biading and aspect of medical insurance.