OBJECTIVE： To provide ideas for strengthening the supervision of vaccine. METHODS： According to the regulatory defects exposed in the case of Shandong vaccine， combined with own supervision and practice， the problems existing in vaccine regulation were analyzed to put forward suggestions to solve the problem. RESULTS & CONCLUSIONS： There are problems such as supervision system is not perfect； supervision laws and regulations were not perfect； supervision mode is not scientific and so on. It is suggested to perfect regulatory system， improve the regulatory legal system and innovative regulatory approach to ensure reasonable and effective supervision of the vaccine， and improve the quality and safety of the vaccine.