关键词:  , 远程监管；“药监慧眼”工程；“数据湖”；信息化建设；药品监管智慧化

Abstract:

At present， information technology and supervision activities are constantly integrating while the role of innovative regulatory methods， such as digital and movable supervision are continuously highlighted. Remote supervision can improve regulatory efficiency and ensure drug safety by accurately formulating regulatory strategies through intelligent analysis of risk factors. The Medical Products Administration of Yunnan Province is implementing the "drug supervision intelligent eyes" project pilot， which is carried out from points to surface， to achieve remote supervision of drug production safety. During the pilot process， Yunnan Baiyao Group and its subsidiaries solved the problems of data collection， uploading， and pre-warning for enterprises with different levels of informatization through "technology first" and "data empowerment"， providing new ideas for exploring intelligent supervision of drug production. The implementation of the pilot project of the "drug supervision intelligent eyes" not only promotes the informatization construction of enterprises and facilitates the integration of quality management systems， but more importantly， it makes the production process to be identifiable and establish a key link for intelligent supervision. It is an effective approach of risk control throughout the entire life cycle of drugs. This research summarized the implementation and achievements of the pilot projects， and commented the application scenarios of achieving full traceability of drug production process， promoting informatization construction of drug production enterprises， and building regulatory big data. It is suggestted to promote the networked， intelligent， and efficient management of drug safety by encouraging the informatization of the pharmaceutical industry， connecting the traceability and supervision of TCM raw materials， establishing an information security protective system， and constructing intelligent data analysis.

Key words: Remote supervision； , "Drug supervision intelligent eyes" project； , "Data lake"； , Informatization construction； , Intelligent drug supervision