Schlagwort: ‘Drug Saftey’
Beijing: Establishing an “Intelligent Pharmacy Supervision System”
Recently, Beijing Haidian Distinct has launched a test program called the “Intelligent Pharmacy Supervision System.” This system, which uses an HD camera, an e-hygrometer, and e-thermometer, enables remote monitoring of pharmacy business conditions as well as temperature and humidity levels in pharmacies via a mobile App. It also allows for checking whether pharmacists are on duty and whether prescription drugs were sold to customers in accordance withvalid prescriptions.
北京市海淀区试点建设智慧药店监管系统
来源：中国食品药品网 2021.06.22
近日，北京市海淀区试点建设了”智慧药店监管系统”。通过在药店内安装高清视频摄像头及温度湿度监控，”智慧药店监管系统”可通过手机APP远程监控药店的经营情况、温湿度等，并可以查看执业药师是否在岗、是否凭处方销售处方药。
New solution for home expired drug recycling
On June 9th, the first World Congress of Pharmaceutical Retailing announced a “Green Finance Public Service Program for Home Expired Drug Recycling”. The Program intends to establish a drug stock-to-sales supervision system. Based on this program, the Chinese firm Union Drug together with more than 100,000 Chinese pharmacies has built a platform using information technology tools such as artificial intelligence, GPS, and GIS to achieve a full life-cycle monitoring of home expired drugs in terms of collection, transport, storage, and disposal.
世界医药零售业大会开幕 家庭过期药品回收迎来解决新方案
来源：中国高新材料及高新技术 2021.06.10
6月9日，首届世界医药零售业大会发布“绿色金融家庭过期药品回收公益项目”。项目拟依托药联健康与全国超十万家线下零售药店，建立药品存销信息化监管平台，运用人工智能、GPS、GIS等信息技术手段，对家庭过期药品实现从收集、运输、贮存、处置各个阶段的全生命周期监控。
“Dual-Channel Policy” for Medicines under National Medical Insurance Negotiation
Recently, the NMPA and the National Health Commission jointly issued the “Opinions on Establishing and Improving Dual-Channel Management Mechanisms for Medicines under National Medical Insurance Negotiation”. According to the “Opinions”, the reasonable usage of these reimbursed drugs, such as supply and clinical use, will be met through two channels, namely designated medical institutions and designated retail pharmacies, with drug payment covered by the medical insurance payment mechanism. Eligible designated retailed pharmacies should be connected to the Medical Insurance Information Platform and the Electronic Prescription Sharing Platform, and a compliant storage and distribution system should be established to ensure drug safety.
医保药品可“双通道”购买
来源：中华人民共和国中央人民政府 2021.05.11
近期，国家医保局会同国家卫健委出台了《关于建立完善国家医保谈判药品“双通道”管理机制的指导意见》。《意见》提出，将通过定点医疗机构和定点零售药店两个渠道满足医保谈判药品供应保障、临床使用等方面的合理需求，并同步纳入医保支付；符合纳入“双通道”管理的定点零售药店要与医保信息平台、电子处方流转平台等对接，并建立符合要求的储存、配送体系，确保药品质量安全。
The State Council: establishing a national drug traceability collaboration platform
Recently, the State Council issued the “Opinions on Strengthening Drug Supervising Capacity.” The “Opinion” stipulates that the traceability information system be enhanced and a national drug traceability collaboration platform be established to achieve complete drug tracking and tracing and to gradually apply unique identification for medical devices.
国办：构建全国药品追溯协同平台，实现全周期追溯
来源：医药网 2021.05.11
日前，国务院办公厅印发《关于全面加强药品监管能力建设的实施意见》。《实施意见》提出，应完善信息化追溯体系，构建全国药品追溯协同平台，实现药品全生命周期追溯，逐步实施医疗器械唯一标识。
Hainan Free Trade Port: implementing online sales of prescription drugs
On April 8th, the National Development and Reform Commission issued the “Opinions on Supporting the Special Measures to Expand Market Access in the Hainan Free Trade Port.” The “Opinion” indicates that an e-prescription center be contracted in Lecheng to support the online sale of prescription drugs that are not expressly regulated under the national drug administration law. The e-prescription center should be connected to internet hospitals, prescription systems of Hainan medical institutions, various prescription drugs sales platforms, health insurance information platforms, payment and claims processing institutions, and commercial insurance institutions, thereby realizing an “Integrated Online Platform” for the collection of prescription-related information, prescription drugs purchasing, information security certification, and medical insurance claims processing.
海南自贸港：处方药网售落地
来源：医药网 2021.04.20
4月8日，国家发改委发布《关于支持海南自由贸易港建设放宽市场准入若干特别措施的意见》。《意见》指出，要在乐城先行区建立海南电子处方中心，对于在国内上市销售的处方药，除国家药品管理法明确实行特殊管理的药品外，全部允许依托电子处方中心进行互联网销售，不再另行审批。海南电子处方中心对接互联网医院、海南医疗机构处方系统、各类处方药销售平台、医保信息平台与支付结算机构、商业类保险机构，实现处方相关信息统一归集及处方药购买、信息安全认证、医保结算等事项“一网通办”。
The State Council: liberating online drug selling
On April 15th, the State Council issued the “Opinions on Further Improving the Reforms of ‘Streamline the Government, Delegate Power, and Improve the Government Services.'” According to the “Opinion”, prescription drugs that are not under State supervision are allowed to be sold online as long as the source of electronic prescriptions is valid.
国务院：网售处方药部分放开！电子处方需真实可靠！
来源：医药网 2021.04.20
4月15日，国务院发布《关于服务“六稳”“六保”进一步做好“放管服”改革有关工作的意见》（以下简称《意见》）。《意见》提出，在确保电子处方来源真实可靠的前提下，允许网络销售除国家实行特殊管理的药品以外的处方药。
Shanxi: Establishing a Drug Tracing System
Recently, the Shanxi Provincial Medical Product Administration issued the “Working Plan on Establishing Drug Information Tracing System,” which concerns the development of a framework for a drug tracability supervision system by the end of 2020. The “Plan” stipulates that drug manufactures should build their own or use a drug information traceability system established by a third-party platform to share information with the national collaborative drug traceability platform and realise the tracing of special drugs such as narcotic drugs and psychotropic drugs and selected drugs in the provincial centralised procurement.
山西省药监局出台《药品信息化追溯体系建设工作方案》
来源：新浪新闻 2020.12.04
近日，山西省药监局出台《药品信息化追溯体系建设工作方案》，计划到2020年底将完成山西省药品追溯监管系统基础开发。《方案》要求，药品生产企业应自建或选用第三方平台建立的药品信息化追溯系统，并完成和国家药品追溯协同服务平台的数据对接，基本实现麻醉药品、精神药品等特殊药品以及集中采购中标品种的全过程追溯。
Beijing: supervising the drug distribution in pharmacy chains
Recently, the Beijing Municipal Medical Product Administration issued the “Notice on Strengthing the Administration of Drug Trading by Pharmacy Chains.” The “Notice” clarifies that administration departments should strengthen the management of prescription drugs in pharmacy chains; prescription drugs and drugs marked with red OTC can only be sold when a pharmacist is present. The “Notice” stipulates that competent pharmacies in densely populated regions can provide services such as selling unpacked medicines, 24-hour drug sales, and home delivery.
北京： 严管药店药品销售 鼓励药店拆零销售
来源：医药网 2020.11.27
近日，北京市药监局发布了《关于加强药品零售企业销售药品管理的通知》（以下简称《通知》）。《通知》明确，各管理部门应加强药品零售企业处方药的销售管理；执业药师不在岗时，应停止销售处方药及甲类非处方药。《通知》要求，鼓励各区域内有条件的、群众需求较多的药品零售企业开展药品拆零销售、24小时售药、送药上门等药学服务工作。
New regulations of online drug trading
On November 12th, the NMPA issued the “Measures for the Supervision and Regulation of Online Drug Trading (Consultation Paper).” The paper clarifies that drug trading enterprises can only sell drugs that are allowed to be sold; special drugs such as vaccines, anesthetics and psychotropic drugs are not allowed to be traded online. The paper also indicates that drug trading enterprises that are allowed to sell prescription drugs online should check the source of electronic prescription and the dispensing in the prescription and mark the used prescription. Moreover, drug trading enterprises should provide online medical services and employ pharmacists to guide the public to use drug rationally.
药品网售新规来了：不得销售麻醉、精神药品等
来源：医药网 2020.11.13
11月12日，国家药监局公布《药品网络销售监督管理办法（征求意见稿）》。《意见稿》明确，药品网络销售不得超出企业经营方式和药品经营范围；疫苗、麻醉药品、精神药品等特殊药品不得通过网络销售。《意见稿》指出，具备网络销售处方药条件的药品零售企业应检查电子处方来源，审核处方调剂，并对已使用的处方进行电子标记；在销售同时，应当建立在线药学服务制度，配备执业药师，指导合理用药。
Solicting opinions on drug recall
On October 13th, the NMPA issued the “Measures on Drug Recall (Consultation Paper)” to solicit opinions from public. The Consultation Paper stipulates that Markeiting Authorization Holders should establisch and improve the drug recall system, collect information on drug safety issues, and investigate and evaluate defective or potentially harmful drugs in order to recall them on time.
公开征求《药品召回管理办法（征求意见稿）》
来源：医药网 2020.10.14
10月13日，国家药监局综合司公开征求《药品召回管理办法（征求意见稿）》。《征求意见稿》要求，药品上市许可持有人应当建立并完善药品召回制度，收集药品安全的相关信息，对可能存在缺陷的药品进行调查、评估，及时召回缺陷药品。