OBJECTIVE： To put forward game strategy of drug safety regulation， and to provide reference for decision-making by drug regulation department. METHODS： Based on evolutionary game theory， evolutionary game model of drug safety regulation was established， and the stability of evolution during drug safety regulation was analyzed. RESULTS & CONCLUSIONS： There were four possible evolutionary game results of drug safety regulation， including to provide qualified drugs， regulation； to provide unqualified drugs， regulation； to provide qualified drugs， no regulation； to provide unqualified drugs， no regulation. The evolution direction mainly depends on the parameter values involved in the payoff matrix of drug safety regulation. The stable state of drug safety regulation is related to regulation strength， regulation cost， enterprise safety input， probability of accident， accident-related treatment cost， et al. Key strategies to improve drug safety regulation include increasing punishment， improving monitoring technology，strengthening coordination mechanism，promoting social cohabitation and improving industry self-control.