Schlagwort: ‘Information System’
New stipulations on medication managment in pharmacies
On July 1st, the National Medical Products Administration issued the “Stipulations on Management of Drug Data and Records of Drugs.” The “Stipulation” clarifies that one or more types of records methods should be adopted according to the needs of activities, which include developing, producing, trading, and using drugs, and the records process should be veritable, accurate, intact, and traceable. The records can be expressed in papery, electronic or mixed forms, and the recorded data should be managed according to stipulations.
药店药品管理又有新要求了
来源：新浪医药新闻 2020.07.02
7月1日，国家药监局发布了《药品记录与数据管理要求（试行）》（以下简称《要求》），自2020年12月1日起施行。《要求》明确，从事药品研制、生产、经营、使用活动，应当根据活动的需求，采用一种或多种记录类型，保证全过程真实、准确、完整和可追溯。记录载体可采用纸质、电子或混合等形式，并应根据要求对所记录数据进行管理。
Implementing online medical insurance settlement of prescriptions
On May 20th, the “Opinion on Settling the Price and Medical Insurance Payment of ‘Internet+’ Medical Services” issued by the Healthcare Security Administration of Chongqing province came into effect. The “Opinion” stipulates that for the pilot program of the “Internet+” medical insurance services for common and chronic diseases, doctors can issue electronic prescriptions after online consultations and settle up the medication costs online through medical insurance, and it is allowed to deliver medicines to patients in many ways.
线上处方医保支付落地！处方流转迎来新机遇！
来源：医药网 2020.05.21
5月20日，重庆市医疗保障局《关于“互联网+”医疗服务价格和医保支付政策的实施意见》开始实施。《意见》提出，对于正在试点的常见病、慢性病“互联网+”医保服务，患者通过网上问诊后，可由医生开出电子处方，医保在线结算，并且允许通过多种方式为患者进行配送。
Improving the supervision on unreasonable or illegal behaviors of drug online trading
On April 24th, the NMPA held the video conference for renovating the unreasonable or illegal behaviors of drug online trading and administrating the circulation of medicines. The conference indicates that the drug online trading services should be further regulated to realize constant supervision over the entire trading process and ensure the medication safety; use the National Monitoring System to track and detect the unreasonable or illegal behaviors of drug online trading dynamically.
药品网络销售违法违规行为专项整治深入推进
来源： 医药网 2020.04.26
4月24日，国家药品监督管理局药品监管司主持召开药品网络销售违法违规行为专项整治及药品流通监管工作调度视频会。会议强调，应进一步规范药品网络销售和药品网络交易服务，实现全过程、全周期监管，强化公众用药安全保障；利用国家药品网络交易监测系统对网络药品经营违法违规行为进行动态跟踪检测。
Video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs
On April 17th, the NMPA held the video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs by centralized procurement of drugs with defined quantities. The conference stipulated that manufacturers should produce selected drugs according to the manufacturing processes that are defined by the NMPA. Besides, the Marketing Authorization Holders are encouraged to establish a mature drug traceability system to conform to the tracing requirement of “one-code-for-one-drug.”
落实中选药品“一物一码”带量采集专项检查视频会召开
来源：医药网 2020.04.23
4月17日，国家药监局召开国家组织药品集中采购和使用中选药品专项检查工作调度视频会议。会议要求，企业应按照药监部门核准的生产工艺生产中选药品；督促药品上市许可人建立完善信息化追溯体系，落实中选药品“一物一码”追溯要求。
Tibet: supervising retail pharmacies
On April 20th, the Medical Product Administration of Tibet Autonomous Region issued the “Plan on Drug Supervision in Tibet Autonomous Region (2020).” The “Plan” indicates that drugs will be supervised in terms of their production, wholesale, trading, and usage. The “Plan” stipulates that the drug information management system, purchase channels, storage and transport state, auditing, and expiration date of drugs should be inspected, and at the same time, the sales of prescription drugs and services that provide by licensed pharmacists in retail pharmacies will be checked as well.
西藏开始监督检查零售药店
来源： 医药网 2020.04.22
4月20日， 西藏自治区药监局发布了“2020年西藏自治区药品监督检查计划”。“计划”明确，要在今年4月至11月对全区药品生产、批发、经营、使用单位进行检查。“计划”要求，应重点检查药品的计算机管理系统、进货渠道、储运条件、销售票帐货款一致性、有效期，同时检查药品零售企业的处方药销售和执业药师在岗服务。
Two regulations were deliberated and enacted
On March 30th, the State Administration for Market Regulation issued the “Measures for the Administration of Drug Registration” and “Measures for the Supervision of Pharmaceutical Productions,” which will come into effect on July 1st. The two “Measures” stipulate that drug registration and manufacturing should be strictly supervised to make sure the safety of drugs. Besides, the system of Marketing Authorization Holder (MAH) should be implemented comprehensively. Moreover, a drug safety assurance system should be established to manage the life cycle of drugs.
《药品注册管理办法》等两规章审议通过 7月1日起执行
来源：医药网 2020.03.31
3月30日，市场监管总局发布《药品注册管理办法》，《药品生产监督管理办法》，两部规章将于2020年7月1日起正式施行。两项《办法》要求，应严格管理药品注册和药品生产，保障药品质量安全；全面落实上市许可持有人管理制度；建立药品质量保证体系，对药品的全生命周期进行管理。
Ten drug traceability standards are implemented
Recently, the NMPA issued the “Basic Dataset of Drug Traceability for Marketing Authorization Holders and Manufacturers,” “Basic Dataset of Drug Traceability for Pharmaceutical Companies,” “Basic Dataset of Drug Traceability for Medical Organizations,” “Basic Technical Requirements for Drug Traceability Data Exchange,” and “Basic Dataset of Drug Traceability for Consumer Inquiry.” Up to now, ten drug traceability standards that were issued by the NMPA have been implemented.
10个药品追溯标准发布实施，实现来源可查，去向可追
来源：制药网 2020.03.12
近日，国家药监局印发《药品上市许可持有人和生产企业追溯基本数据集》，《药品经营企业追溯基本数据集》，《药品使用单位追溯基本数据集》，《药品追溯数据交换基本技术要求》,《药品追溯消费者查询基本数据集》。截止目前，国家药监局组织编制的10个药品追溯标准规范现已全部发布实施。
Deepening the reform of the medical and health care system
On February 25th, the State Council issued the “Opinions on Deepening the Reform of the Medical and Health Care System.” The “Opinion” stipulates that medical institutions should improve the management of drug reimbursement lists, medical service protocols, and medicare settlement or increase the efficiency of medicare payment. Besides, the use of medical insurance funds should be strictly supervised, and insurance fraud will be dealt with according to legislation. In addition, the reform of centralized drug procurement should be deepened, and a pricing system that depends on the market should be established. Moreover, medical institutions should improve their service capacity and standardize new medical services, such as consulting over the internet.
关于深化医疗保障制度改革的意见
来源：医药网 2020.03.06
2月25日，国务院发布《关于深化医疗保障制度改革的意见》。《意见》要求，应完善医保目录、协议、结算管理，提升医保支付效率；完善医保基金监管，依法追究欺诈骗保行为；深化药品集中带量采购制度改革，并建立以市场为主导的药品价格形成机制；增强医疗服务能力，规范“互联网+医疗”等新服务模式发展。
Hospital pharmacies and pharmacy chains cooperate
Recently, the Medical Product Administration of Guizhou province issued the “Notification on Improving Pharmacy Chains Management in Guizhou Province.” The “Notification” indicated that pharmacy chains are encouraged to provide pharmaceutical services jointly with hospital pharmacies according to their own supply practice. Besides, online prescribing and pharmaceutical services should be promoted as well.
医院药房要与药店打通了
来源：新浪医药新闻 2019.12.27
近日，贵州省药监局发布了《关于进一步规范全省药品零售企业管理工作的通知》（以下简称《通知》）。《通知》提出，药品零售企业在不改变药品经营方式的前提下，鼓励为社区医疗机构提供药房药事服务；积极推进“互联网+远程药学服务”进行远程审方。[:]
A national drug use supervision platform is launched
The National Health Commission announced that a national drug use supervision platform is launched, which can provide data to support healthcare administrations to supervise and analyse the drug use. 8840 medical institutions have registered on the platform.
国家药品使用监测平台上线运行 8000多家医院已登陆
来源：医药网 2019.12.11
国家卫健委统计信息中心今日发布消息，国家药品使用监测平台正式上线运行。目前，已有8840家医疗卫生机构完成系统登录。卫健委表示，“国家药品使用监测平台”将为各级卫生健康药政管理部门开展药品配备使用情况监测分析提供数据支撑。