Schlagwort: ‘Government Supervision’
Guangzhou: a implementation opinion on promoting the application of health and medical big data is released
Recently, the Guangzhou General Office of the People’s Government published “The Implementation Opinion on promoting the Application of Health and Medical Big Data”. The “Opinion” proposed to improve the medical data collection mechanisms and establish a catalog of health and medical data resources in the city to realize the sharing of data resources across departments and regions. It stipulates to develop the application of health and medical big data in order to provide a whole process of online medical services for citizens. A unified drug prescription circulation platform should be established so as to realize information interconnection between hospitals, pharmacies, and delivery companies.
广州印发推进健康医疗大数据应用实施意见
来源：医药网 2019.01.04
核心提示：近日，广州市政府办公厅印发了《关于推进健康医疗大数据应用的实施意见》（下称《意见》）。《意见》提出，健全医疗数据采集机制，建立全市健康医疗数据资源目录，实现数据资源跨部门、跨区域共享；发展健康医疗大数据应用，为市民提供全流程在线诊疗服务；建立统一的药品处方流转平台，实现医院、处方流转平台、药店和配送系统的信息互联互通。
A supplementary document for procurement of drugs is released(“4+7”)
On December 27th, the State Food and Drug Administration issued the “Notification on reinforcing drug supervision during the pilot of centralized procurement and use of selected drugs.” The “Notification” stipulated that each provincial drug regulatory authority should reinforce the quality supervision of the production, circulation, and use of selected drugs and the punishment for enterprises that violatie laws and regulations. The regulation authority should also urge the selected enterprises to establish a reporting system for inventory and off-production. The “Notification” indicates that the drug distribution should be regulated through related treaties to ensure the drug supply.
国家药监局发布4+7配套文件， 确保中标药品质量安全
来源：制药站 2018.12.28
核心提示：12月27日，国家药监局发布《国家药监局关于加强药品集中采购和使用试点期间药品监管工作的通知》（以下简称《通知》）。《通知》要求，各省级药品监管部门应加大对中标药品生产、流通、使用全周期的质量监管，加大违法违规企业的处罚力度，要督促中标生产企业建立企业库存和停产报告制度。《通知》指出，应通过协议规范配送行为，以保证药品供应。
The National Essential Drugs List (2018 edition) is officially released
On October 25th, the state released the “National Essential Drugs List (2018 edition)”.The “List” will be officially implemented nationally starting November 11ths. The total number of medicine on the “List” has increased from 520 to 685. The Adjustment of the “List” is based on the coverage of the main clinical diseases, focusing on cancer, pediatrics, chronic diseases, etc. adding 187 kinds of Chinese and Western medicines.
国家基本药物目录（2018年版）正式发布
来源：制药站 2018.10.26
核心提示：10月25日，国家正式发布了《国家基本药物目录（2018年版）》（以下简称“基药目录”），目录将于11月1日起在全国正式实施。本次基药目录总品种由原来的520种增加到685种。此次基药目录的调整在覆盖临床主要病种的基础上，聚焦癌症、儿科、慢性病等调入187种中西药。
Fujian encourages the implementation of electronic first transaction information of drugs
On October 10th, Fujian Food and Drug Administration published “Notification on encouraging drug production and management enterprises to implement electronic first transaction information of drugs”. The “Notification” indicates that pharmaceutical enterprises and medical institutes are encouraged to use the Internet to establish a drug traceability system and an electronic exchange platform for the first transaction information. The “Notification” also stipulates that the platform should comply with the relevant national laws and regulations, and undertake the corresponding legal responsibility.
福建鼓励实施药品首营资料电子化
来源：中国医药报 2018.10.12
核心提示：10月10日，福建省食品药品监管局印发《关于鼓励药品生产经营企业实施药品首营资料电子化的通知》（以下简称《通知》）。《通知》指出，鼓励药企及医疗机构运用互联网建立药品追溯体系和首营资料电子化交换平台。《通知》要求，平台应符合国家相关法律法规规定，并承担相应的法律责任。
The upper limit of patients serviced by a contracted family doctor is 2000
On October 8th, the official website of the National State Council officially issued the “Guiding Opinions on Standardising the Management of Contracted Family Doctor Services”. The “Guiding Opinion” clarifies that the number of patients serviced by a contracted family doctor should not exceed 2000. The “Guiding Opinion” indicates that the service charge should be properly accounted for and allocated and fundraising channels to support family doctors should be broadened. The “Guiding Opinion” stipulated that while promoting the service of “Internet+Contracted Family Doctor”, the management and assessment of contracting service should be strengthened.
国家卫健委：每名家庭医生签约服务人数上限2000人
来源：医药网 2018.10.10
核心提示：10月8日，国家卫生健康委员会官网正式发布《关于规范家庭医生签约服务管理的指导意见》。《意见》明确，每名家庭医生签约人数不得超过2000人。《意见》指出，应合理核算并分配签约服务费，并拓宽签约服务费筹资渠道。《意见》强调，推进“互联网+家庭签约医生”服务的同时，应强化对签约服务的管理与考核。
Opinions of the national basic medical system would be released
On September 19th, 2018, the State Council published “Guiding opinions on the improvement of the national basic medical system.” The “Guiding opinions” stipulates the establishment of a wholesome drug use monitoring platform and monitoring network system.It persists in centralized drug procurement, implements drug classification and acquisition; encourages local areas to combine basic drug system with classified medical treatment, family doctor contracting services and chronic disease health management so as to reduce the financial burden of patients. It establishes a wholesome national shortage of drug monitoring and early warning system, by the way of a reasonable purchase price, fixed-point production and unified distribution to ensure drug supply.
国家基本医药制度意见出台
来源：中国制药网 2018.09.19
核心提示：9月19日，国务院印发《关于完善国家基本医药制度的意见》。《意见》要求，建立健全的药品使用监测平台以及监测网络体系；坚持药品集中采购，落实药品分类采购；鼓励地方将基本药物制度与分级诊疗、家庭医生签约服务、慢性病健康管理结合，降低患者负担；建立健全的全国短缺药品监测预警系统，确定合理采购价格、定点生产、统一配送以保证药品供应。
The electronic drug regulation will be recommissioned
On August 24th, 2018, the State Food and Drug Administration issued “Guiding Opinions on the Construction of a Drug Information and Traceability System (consultation paper)”. The “Guiding Opinion” stipulates that licensed sellers of drugs and pharmaceutical enterprises should each establish their own traceability system. The ownership of the drug traceability data is determined by the principle “who generated, who owns”. It encourages Holders, pharmaceutical enterprises, users, industry associations, third-party service agencies, and administrative departments to implement the interconnection of drug information traceability through the drug traceability collaborative service platform.
国家药监局: 重启药品电子监管
来源：医药网 2018.08.27
核心提示：8月24日，国家药监局发布《关于药品信息化追溯体系建设的指导意见（征求意见稿）》（下称《意见》）。意见要求，药品上市许可持有人和药企应自建追溯系统；药品追溯数据的所有权为“谁产生、谁所有”；鼓励持有人、药企、使用单位、行业协会、第三方服务机构、行政管理部门通过药品追溯协同服务平台实现药品信息化追溯各方互联互通。
Medical insurance: Hospitals will be charged for insufficient medication
Recently, the Shanghai Municipal Bureau of Human Resources and Social Security, the Medical Insurance Office, the Health Planning Commission, the Food and Drug Administration, and the Price Bureau jointly issued “Notification on the Third Batch of medical insurance drug procurement with target quantity in Shanghai”. The “Notification” clarifies that all medical institutions across the city should give priority to purchasing and using the winning drugs of drug procurement with target quantity. Hospitals that are unable to complete normal purchase would be deducted from the medical insurance expenses. The “Notification” also stipulates that any form of “the Secondary negotiation“ is strictly prohibited.
医保：用药不足，医院将被扣费
来源：医药网 2018.08.27
核心提示：近日，上海市人社局、医保办、卫计委、食药监局、物价局五部门联合发布“关于做好本市第三批医保药品带量采购有关工作的通知（以下简称通知）”。通知明确，本市所有医疗机构应优先采购和使用带量采购中标药品，无法完成正常采购量的医院将被相应扣减医保费用额度。通知还要求，严禁任何形式的二次议价。
Anhui establishes a Drug Quality and Security Traceability System for pharmaceutical enterprises
Recently, the Anhui Food and Drug Administration issued the “Guiding Opinions on the Construction of Drug Quality and Safety Traceability System for Pharmaceutical Enterprises in Anhui Province.” The “Guiding Opinions” clarify that pharmaceutical enterprises all over the province should establish a drug traceability system in accordance with laws and regulations. The traced information content of all links of the drug business should be true, accurate and complete, and should be saved at least for five years. For those who have not yet established a traceability system and for those traceability systems who do not operate effectively, especially when included incorrect information or incomplete information, it will be seriously investigated and dealt with following relevant laws and regulations.
安徽部署建立药品经营企业质量安全追溯体系
来源：中国医药报 2018.08.03
核心提示：日前，安徽省食品药品监管局印发《安徽省药品经营企业药品质量安全追溯体系建设指导意见》（以下简称《意见》）。《意见》明确，全省药品经营企业应按照法律法规建立药品追溯制度，药品经营各环节追溯信息内容应真实、准确、完整，且至少保存五年。对于没有建立追溯体系、追溯体系不能有效运行，特别是出现不真实信息或信息丢失的，将依照相关法律法规严肃查处。
The government of Inner Mongolia wants to eliminate the adjuvant drugs in the top 50 list of drugs with the highest purchase amount
On July 8th, the Health Commission of Inner Mongolia Autonomous Region issued the “Notification on Effective Measures to Control the Unreasonable Increase in Medical Expenses” and requested that it should be officially implemented on July 15th, 2019. The “Notification” stipulates that medical expenses should not exceed 30% of total hospital expenses (Anticancer drugs and drugs for treating chronic diseases are not included). At the same time, the top 100 drugs with the highest purchase amount should be monitored, the adjuvant drugs in the top 50 should be eliminated, and expensive drugs should be replaced with drugs with the same generic name and cheaper. Besides, medical institutions should reduce the purchases or discontinue to use the drugs, which are in the top 20 with the highest purchase amount for three consecutive months.
慢性病药不计药占比！剔除采购金额前50中的辅助药品
来源：医药网 2018.07.10
7月8日，内蒙古自治区卫健委发布《关于有效控制医疗费用不合理增长具体措施的通知》，并要求于2019年7月15日起正式执行。《通知》要求，各级医院应将药占比必须控制在30%以内（抗癌药品和慢病用药不列入计算范围）。同时，应对采购金额排前100名的药品进行重点监控，剔除前50名中的辅助药品，对价格贵的药品要用同通用名并且价格低的药品替代。此外，对在各医疗机构连续三个月消耗金额排名前20位的药品，应当立即减少采购量或停止使用。