探索药品生产智慧监管,筑牢药品质量安全防线  

Exploring intelligent regulations for drug production,building robust line of defense for drug quality and safety

作　　者：楼双凤 LOU Shuangfeng(Shanghai Center for Drug Evaluation and inspection, shanghai 201210, China)

机构地区：[1]上海药品审评核查中心,上海201210

出　　处：《上海医药》2018年第9期51-53,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：近年来,随着国家对药品监管信息化建设的高度重视和信息化技术的快速发展,各地药品监管机构都在积极探索和推进药品监管信息化进程。本文从探索药品生产智慧监管的初衷出发,从建设目标、实践过程、主要功能、目前已取得的成效以及下一步思考等方面对药品生产智慧监管系统进行了分析和介绍。In recent years, drug regulatory agencies throughout the country have been actively exploring and advancing the informationization process of drug supervision with the relevant authorities of the country attaching great importance to the informationization of drug supervision and the rapid development of information technology. This article focused on the analysis and introduction of a intelligent regulation system for drug production starting with the original intention of exploring intelligent supervision for pharmaceutical production from some aspects such as the construction goals, the practical process, the main functions, and the results achieved so far and the consideration of next step.

关 键 词：药品生产 智慧监管 质量安全 

分 类 号：F423.3[经济管理—产业经济]