Abstract:According to the system defects in China’s current drug safety and regulatory issues exposed by the Changsheng Biological Vaccine Case, combined with the actual supervision, the problems in vaccine supervision and propose solutions were studied. There are problems such as improper supervision and regulatory legal system, as well as the lack of effective control mechanism in vaccine supervision. The legal system for vaccine supervision and the vaccine supervision system should be improved to for the regulatory role of the market mechanism, the vaccine safety governance model should be innovated to strengthen the level of vaccine safety supervision in China.