OBJECTIVE：To provide reference for improving the supporting system of drug safety governance in China. METHODS：Through analyzing the main ways ，characteristics and effectiveness of drug safety governance in Australia ，the suggestions for building drug safety governance system in China were put forward initially. RESULTS & CONCLUSIONS ：The methods of Australia ’s drug safety governance are to conduct division of labor between the federal and state/territory governments ， advanced-voluntary-bundled-payment-model. conduct policy consultations with different related entities separately ，guide industry self-discipline based on industrial development level，and support industry to participate in drug advertising supervision. Australia ’s drug safety governance has the characteristics of large information sharing channels ，increasing the transparency of government work ，carrying out targeted education and enhancing the governance capacity of participants etc. It has achieved significant improvement in the occurrence of drug recall events，and significant increase in the satisfaction of stakeholders in the communication activities of drug regulatory authorities. In contrast，the participation consciousness and ability of relevant entities in China are still not strong ，and the system to ensure the participation of these entities is not yet sound. It is recommended that China should pay more attention to the communication between the upper and lower levels of governments ，conduct targeted education or training for principals of non-government entities， implement the policy consultation rights of non-government entities ， as well as guide self-discipline based on self-management ability of industry entities so as to initially establish drug safety governance system in China ，and enhance the governance efficiency.