Schlagwort: ‘Information System’
The NMPA: implementation of Diagnosis-Intervention Packet
On October 19th, the NMPA issued the “Notice on the Pilot Work of the Regional Point-Based Medical Insurance Fund Allocation and the Diagnosis-Intervention Packet.” The “Notice” stipulates that medical institutions should change the costs of each medical services into points; the regional medical insurance bureaus should calculate the value of each point according to the amount of points provided by all medical institutions of each region and the budget of medical insurance funds to pay for those medical institutions (Diagnosis-Intervention Paket). The “Notice” indicates that a data center on the basis of the unified national medical insurance information coding list should be established, which can inspect the quality of medical insurance settlement checklists, medical insurance cost schedule etc.
国家医保局发布区域点数法总额预算和按病种分值付费试点工作方案
来源：HIT专家网 2020.10.20
10月19日，国家医保局下发《国家医疗保障局办公室关于印发区域点数法总额预算和按病种分值付费试点工作方案的通知》（以下简称《通知》）。《通知》要求，医疗机构应将治疗项目等付费单元转化为一定点数；医保部门年底根据各医疗机构所提供服务的总点数以及地区医保基金支出预算得出每个点的实际价值，按照各医疗机构实际点数付费。《通知》指出，应打造数据中心，在全国统一的相关医保信息业务编码的基础上，开展医保结算清单、医保费用明细表等质量控制工作。
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。
NMPA: establishing a traceabiliy system of specially regulated drugs
On August 28th, the NMPA issued the “Notice of establishing the traceability system of special drugs.” The Notice indicates that the Marketing Authorization Holders should establish traceability systems and collect the information from the traceability process to realise the traceability of special regulated drugs, such as selected drugs, before December 31st. At the meantime, the NMPA should establish a Coordination Platform of traceability systems, which provides coding rules of drug traceability codes and services that encode the IP-Adresse of traceability systems that are established by Marketing Authorization Holders to help to realise the information sharing between the different traceability systems.
国家药监局：做好重点品种信息化追溯体系建设工作
来源：医药网 2020.10.14
8月28日，国家药监局发布《关于做好重点品种信息化追溯体系建设工作的公告》。《公告》指出，药品上市许可持有人应建立信息化追溯系统并收集全过程追溯信息，于2020年12月31日之前，基本实现国家药品集中采购中选品种等重点品种可追溯。同时，国家药监局应建设药品追溯协同服务平台，协同平台提供药品追溯码编码规则备案和药品上市许可持有人药品信息化追溯系统地址解析服务，辅助实现不同追溯系统互通互享。
The State Council: encouraging online drugs trade, prescription sharing and online medical consulting services
On September 21st, the State Council issued the “Opinions on Accelerating the Development of Consumption Created by New Forms of Bussiness”. The “Opinion” stipulates that a public service platform of online and e-commerce services should be established and improved to accelerate the integration of online and offline services; online medical services should be developed, which means scheduled appointments of consulting services, online medical consulting services, prescription sharing and online drugs trade will be promoted.
国务院力挺网络售药、处方流转、互联网医疗
来源：医药网 2020.09.23
9月21日，国务院办公厅印发《关于以新业态新模式引领新型消费加快发展的意见》（以下简称《意见》）。《意见》要求，应建立健全“互联网+服务”、电子商务公共服务平台，加快社会服务在线对接、线上线下深度融合；积极发展互联网健康医疗服务，大力推进分时段预约诊疗、互联网诊疗、电子处方流转、药品网络销售等服务。
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。