中新网10月8日电 国家食品药品监督管理局今日在其官方网站公布《药品电子监管工作指导意见》。意见要求，各级药品监督管理部门应当及时处理电子监管网产生的预警，高风险预警(药品已过有效期、批准文号已过有效期、企业证书已过有效期、特药相关预警)必须在一个工作日内完成处理工作。

Beijing on October 8, state food and drug administration today announced in its official website[Drug electronic supervision work instruction opinion].Opinion request,The pharmaceutical supervisory and administrative departments at all levels shall timely deal with electronic supervision from the nets early warning,High risk early warning(The validity of the drug has passed/Approval number has been validity/The enterprise has passed the validity of the certificate/TeYao related early warning)Must be in a working days work is finished.

　　意见要求加强入网管理。省局负责辖区内各级药品监督管理部门和辖区内企业与进口药品代理机构的入网审核工作。

Opinion request to strengthen the management of the net.ShengJu responsible for all levels within the jurisdiction of the pharmaceutical supervisory and administrative departments and within the jurisdiction of the enterprise and the import drug agency access audit work.

　　意见明确基础信息维护相关事项。在相关资料齐备的情况下，限期完成以下信息审核和维护工作：

Opinion clear foundation information maintenance related matters.In the related material complete cases,Complete the following information within a prescribed time limit, audit and maintenance work:

　　——药品信息维护。国家局负责电子监管网的药品注册信息和进口药品代理机构备案信息维护。维护工作在三个工作日内完成。

- drug information maintenance.GuoGuJu responsible for electronic monitoring net drug registration information and import drug agency for the record information maintenance.Maintenance work in three working days to finish.

　　——企业入网审核。省局负责审核辖区内入网企业的合法性和信息准确性，审核工作在三个工作日内完成。

- enterprise access audit.ShengJu responsible for checking the legitimacy of the net within the jurisdiction of enterprise and information accuracy,Audit work in three working days to finish.

　　——企业变更名称审核。省局负责审核辖区内入网企业变更名称的合法性，审核工作在三个工作日内完成。

- enterprise changes its name audit.Responsible for checking ShengJu within their respective jurisdictions into enterprise changes its name legitimacy,Audit work in three working days to finish.

　　——企业证书信息维护。省局负责及时在电子监管网维护辖区内企业的药品生产许可证、药品经营许可证以及《药品生产质量管理规范》(GMP)和《药品经营质量管理规范》(GSP)认证信息，维护工作在三个工作日内完成。

- enterprise certificate information maintenance.ShengJu responsible for timely in the electronic supervision network maintenance within the jurisdiction of enterprise's drug production licenses/Drug business license and[The quality control standard for pharmaceutical production](GMP)and[The quality control standard for pharmaceutical business](GSP)Authentication information,Maintenance work in three working days to finish.

　　——特殊包装赋码审批。对于药品最小包装体积过于狭小或属于异型瓶等特殊情况，无法在药品最小包装上加印(贴)统一标识药品电子监管码的品种，可在最小包装的上一级包装上加印(贴)统一标识的药品电子监管码。具体品种由药品生产企业向企业所在地的省局提出申请，由省局负责严格审查，有效杜绝有条件在最小包装赋码但申请中包装或大包装作为最小包装进行赋码的情况出现，审批工作须在五个工作日内完成。

- special packaging fu code for examination and approval.For drug minimum packing volume too narrow or belongs to different bottle and other special situation,Not in the least drugs packaging overprint(stick)Unified label drug electronic monitoring code varieties,But at a minimum of packing on the primary packaging prints(stick)Unified label drug electronic monitoring code.Specific variety by the pharmaceutical production enterprise to enterprise is put forward ShengJu application,By ShengJu responsible for scrutiny,Effective eliminate conditional in the least packaging fu code but application package or large packaging as a minimum packaging fu code situation,The examination and approval work must be completed in five working days.

　　意见要求，加强生产环节监管。各级药品监督管理部门应加强辖区内生产企业和代理机构所代理境外制药厂商药品电子监管实施工作，检查督促生产企业和境外制药厂商按照国家局的统一部署加入电子监管网，做好药品电子监管码赋码、核注核销工作。

Opinion request,To strengthen the supervision of production links.The pharmaceutical supervisory and administrative departments at all levels should strengthen within the jurisdiction of the production enterprise and agency have agency overseas pharmaceutical manufacturer drug electronic supervision and implementation work,Check supervise production enterprises and overseas pharmaceutical manufacturers GuoGuJu in accordance with the unified plans to join electronic monitoring network,Do drug electronic monitoring code fu code/Nuclear note cancel after verification work.

　　意见明确经营环节监管措施。各级药品监督管理部门应加强辖区内经营企业药品电子监管实施工作，督促企业按照国家局的统一部署加入电子监管网，做好药品电子监管核注核销工作。

Opinion clear business link regulatory measures.The pharmaceutical supervisory and administrative departments at all levels should strengthen the business enterprise drugs within the jurisdiction of the electronic supervision and implementation work,Supervise the enterprise in accordance with the unified plan of GuoGuJu join electronic monitoring network,Do drug electronic monitoring nuclear note cancel after verification work.

　　意见指出，国家局维护麻醉药品、第一类精神药品生产和收购计划信息。各级药品监督管理部门加强药品电子监管与特殊药品日常监管的结合，提出特殊药品电子监管的功能需求。

Opinion pointed out that,GuoGuJu maintenance narcotic drugs/The first kind of psychotropic drugs production and acquisition plan information.The pharmaceutical supervisory and administrative departments at all levels to strengthen drug electronic supervision and special supervision of drugs daily combination,Put forward special drug electronic supervision function demand.

　　意见对监管应用做出明确，要求结合本地信息化建设工作，加强药品电子监管与日常监管的融合，积极提出数据共享、资源利用、业务深化等功能需求，提高日常监管效能。

Opinion for regulatory application to make clear,Requirements in the local information construction work,Strengthen the drug electronic supervision and daily supervision of fusion,Made positive data sharing/Resource utilization/Business deepening functional requirements,Improve the efficiency of daily supervision.