基于资源共享与安全可信的药监云实践研究与思考

Research and Thinking on the Practice of Drug Supervision Cloud Based on Resource Sharing,Safety and Credibility

为加强药品安全监管,实现药品监管服务协同高效、资源共享、安全可信,本研究基于云计算在药品监督领域的应用实践,采用“私有云+专属云+公有云+灾备云”的混合云架构和“三层服务”模式,构建“五层两体系”建设体系。共享体系建设中,聚合“资源碎片”软硬一体化共享平台,创新资源动态调整策略,构建国家药监云“数据即服务”的数据共享体系;安全可信体系建设中,技术与管理并举,制定完善的技术规范与管理办法,履行数据备份、日常运维、安全服务,打造统一安全管理运营平台。药监云现已初步建成,多源融合全方面支持了五大类多业务药监系统,特别是疫情防控期间,成功保障了若干重要业务系统的安全稳定运行。展望未来,融合生态链打造行业级药监云,赋能智慧药监高质量可持续发展。

In order to strengthen drug safety supervision and realize efficient,collaborative,resource sharing,safe and reliable intelligent drug supervision service,this study adopts the hybrid Cloud Architecture of"private cloud+exclusive cloud+public cloud+disaster recovery cloud"which is based on the application practice of cloud computing in the field of drug supervision,provides a three-tier service mode,and constructs a"five-tier two system"construction system.In the construction of sharing system,the software and hardware integrated sharing platform aggregated"resource fragments",the dynamic adjustment strategy of resources is innovated,and the data sharing system of"data as a service"in the cloud of drug supervision is constructed.In the construction of security and trust system,technology and management are developed simultaneously,and perfect technical specifications and management methods are formulated to perform data backup,daily operation and maintenance,and security services,create a unified security management and operation platform.The drug supervision cloud has been initially established,and multi-source integration has fully supported five categories of multi-service drug supervision systems.Especially during the period of epidemic prevention and control,the safe and stable operation of the important business system were successfully guaranteed.Looking forward to the future,we should integrate the ecological chain to create industry level drug supervision cloud,and enable the high-quality and sustainable development of intelligent drug supervision.