关键词: 大数据, 药品, 科学监管, 信息化

Abstract:

Drug regulatory work is of great significance for ensuring drug safety for the public， maintaining social stability， and promoting the development of the pharmaceutical industry. In recent years， drug regulatory authorities have been exploring more scientific regulatory ways. Big data， as a new type of data management approach and mindset， has become an important force to promote the development of scientific drug supervision. This study reviews the operation mode of big data and scientific drug supervision， and the exploration of integrating and applying of big data in the field of drug supervision， such as improving regulatory efficiency， enabling intelligent supervision， conducting risk monitoring and early warnings， and promoting industrial innovation and development. It analyzes the current status and challenges in implementing intelligent drug regulation in Gansu province， including insufficient data interconnection， under-utilization of data resources， potential data security risks， and limited regulatory resources. In view of these issues， and considering local regulatory realities， this study proposes strategic recommendations for leveraging big data to modernize scientific drug supervision in Gansu province， including establishing a big data center for drug regulation， innovating regulatory models， strengthening data security frameworks， and accelerating the cultivation of interdisciplinary talent. The aim is to utilize big data to coordinate the resources of all parties involved in supervision， further integrate digitalization and intelligence， continuously empower the modernization of scientific drug supervision in Gansu province， and provide theoretical references for advancing "smart regulation" initiatives in drug regulatory systems.

Key words: Big data, Drug, Scientific supervision, Informationization