摘要
药品监管信息化建设是提升药品安全治理水平和监管效能的重要手段。建立“一品一档”的药品品种档案管理系统是药品品种信息电子化管理的重要抓手,可实现药品受理审查、审评审批、检查检验等信息统一、安全管理,逐步打造我国药品监管的新模式。而药品品种档案数据采集、传输与存储过程中,数据是否同步、不被篡改是确保数据安全性、真实性和完整性的关键因素。目前,区块链技术在数据加密验证、可追溯、防篡改等数据安全可控方面具有明显优势。本研究拟将区块链技术应用到药品品种档案管理系统中,规划设计了基于药品品种档案的区块链技术架构,实现信息公开透明、不可篡改、多点实时同步等功能,并结合数据报送、入库、调用、验真有关工作场景进行应用与实践,旨在加强药品品种信息在传输、存储、调用方面的安全防护水平,为区块链在药品品种档案中的应用提供思路和参考。
Informatization construction of drug supervision is an important means to improve drug safety governance level and supervision efficiency.The establishment of the"one product,one file"drug variety files management system is an important starting point for the electronic management of drug variety information,which can realize the unified and safe management of information such as drug acceptance review,review and approval,test and inspection,and gradually create a new mode of drug supervision in China.In the process of drug variety files data collection,transmission and storage,whether the data is synchronized and not tampered is the key factor to ensure data security,authenticity and integrity.At present,blockchain technology has obvious advantages in data encryption verification,traceability,tamper proof and other aspect of data security and controllability.This research applies blockchain technology to the drug variety files management system.A blockchain technology architecture based on drug variety files,was designed to realize the functions of information openness and transparency,tamper proof,multi-point real-time synchronization,and the application and practice are combined with the work scenarios related to data submission,warehousing,call and verification,aiming to strengthen the security protection level of drug variety information in terms of transmission,storage and call,which provides ideas and references for the application of blockchain technology in drug variety files.
作者
田雅轩
王迎利
TIAN Yaxuan;WANG Yingli(Center for Information of NMPA,Beijing 100044,China)
出处
《中国医药导刊》
2022年第10期1009-1015,共7页
Chinese Journal of Medicinal Guide
作者简介
田雅轩,女,高级工程师,研究方向:药品监管信息化建设。E-mail:156130255@qq.com。
