OBJECTIVE： To provide reference for improving cold chain drug management， and guaranting the quality and safety of cold chain drugs. METHODS： The situation of drug cold chain management in a third grade class A special hospital was analyzed from aspect of cold chain drug temperature and humidity records， circulation and transport process management and storage equipment before the establishment of the automatic monitoring management system of drug cold chain. The system problems and risks were summarized. The newly established drug cold-chain automatic monitoring management system in our hospital was introduced from aspect of software and hardware equipment， system architecture， the determination of monitoring stations and numerical control， early warning mechanism and condition setting， the application of the system. The effectiveness of new system was evaluated by comparing the manual record temperature and humidity in the first five months of 2017 （before construction） and newly-built system monitoring record from Jun. to Oct. in 2017 （after construction）. RESULTS： The traditional cold-chain drug management in this hospital had a series of problems， such as high risk of cold-chain drug return and poor overall supervision of real-time monitoring， disconnect regulation， etc. The establishment of drug cold chain automatic monitoring management system， had realized 24 hours real-time monitoring of each monitoring area in the hospital. The system could automatically record and store， acousto-optic alarm， send short message and WeChat early warning， and went back to check the temperature and humidity records. It could trace back the temperature and humidity records. In the first five months of 2017， manual record temperature and humidity early-warning was only 90 times， but no warning can be achived； it was up to 443 times from Jun. to Oct. in 2017 monitored by the new system. CONCLUSIONS： The establishment of automatic monitoring and management system of cold chain drug in hospital ensures the standard and reliability of cold chain drug storage， the safety and effectiveness of drug quality.