关键词: font-size:medium, ">药品安全；远程监管；远程视频；关键点参数

Abstract: The application of new supervisory means such as off-site supervision is the requirement of digital government construction， and it is one of the main tasks of the construction of “internet+supervision” system.The purpose of using off-site supervision is to make up for the weak links of supervision， improve regulatory efficiency， and promote the digital transformation of pharmaceutical enterprises and the high-quality development of the pharmaceutical industry. By explaining the current situation and solutions of off-site supervision at home and abroad， this paper studies the methods and approaches of off-site supervision of drug safety in line with the national conditions of China. The system construction is based on the high-definition video and the IoT sensing equipment， extracting the risk point data affecting the product quality， collecting the enterprise quality management data and production process control data， and constructing the regulatory big data application scenarios， find， analyze and judge the risks and behaviors affecting the product quality， record the problems found and issue the off-site inspection report. The regulatory authorities issue regulatory opinions according to the off-site inspection report， and directly request the enterprise to rectify， or transfer the regulatory opinions to the law enforcement personnel for on-site inspection and disposal.The practical experience on the off-site supervision of drug safety in Hubei Province provides new ideas and new methods for the off-site supervision of drug safety， and provides beneficial exploration and practice for promoting the intelligent supervision of drug safety.

Key words: font-size:medium, ">Drug safety； Off-site inspection； Remote video； Key point parameters