摘要
Abstract
In order to implement the National Medical Products Administration's unified deployment of intelligent drug supervision,enhance the smart regulatory level in the drug production process,and improve the ability to guarantee the quality and safety of drugs,Henan Medical Products Administration,based on learning from the advanced experiences of intelligent drug supervision in other provinces and considering the actual situation of information construction in drug production enterprises in Henan Province,has issued and implemented the smart regulatory plan for drug production in Henan Province.The"Thousand-Mile Vision Project"for intelligent supervision of drug production in Henan Province has been established,focusing on"the construction of key data platforms for batch records,remote video monitoring platforms,and the development of mobile inspection App".It has already covered 356 drug production enterprises across the province except for medicinal auxiliary materials.Despite the deficiencies and challenges encountered during its implementation,the"Thousand-Mile Vision Project"has enabled regulatory personnel to carry out remote inspections of drug production sites and realize paperless remote intelligent supervision of drugs round the clock,throughout the period,and throughout the process.It has effectively addressed issues such as limited drug regulatory personnel,numerous regulatory objects,and low regulatory efficiency,serving as a useful supplement to on-site inspections by regulatory personnel.关键词
药品生产/智慧监管/千里眼工程/建设情况/存在不足Key words
medical production/intelligent supervision/Thousand-Mile Vision Project/construction status/shortcomings分类
医药卫生
