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。
The “One Invoice Policy” will be implemented
On March 5th, the State Council issued a document on reforming the medical and health care system. The document indicates that a regional and a national allied procurement system should be implemented to realize an orderly drug supply system with reasonable prices and competition; medical insurance agencies should deal with the settlement payment directly with manufacturers or pharmaceutical companies. Besides, provincial centralized procurement platforms that are based on medical insurance payment should be established, which combines bidding, procurement, trading, settlement, and supervision.
国务院：推行一票制 经销商结款方式要变了
来源：医药网 2020.03.09
3月5日，国务院官网发布医疗保障制度改革文件。文件提出，将推进构建区域型、全国性联盟采购机制，形成竞争充分、价格合理、规范有序的供应保障体系；推进由医保经办机构直接与药品生产或流通企业结算货款；应以医保支付为基础，建立招标、采购、交易、结算、监督一体化的省级招标采购平台。
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。
Price management in medical institutions
On January 2nd, the National Health Commission issued the “Standard of Price Management in Medical Institutions,” which will come into effect as the date of promulgation. The “Standard” indicates that medical institutions should establish a price management system that is consisted of several departments. Besides, the “Standard” stipulates that medical institutions should make several staffs supervise the medical costs and adjust unreasonable charges. Besides, medical institutions should establish a system that can analyze and manage the medical service cost and make the costs of common medical services public.
国家卫健委：医疗机构内部价格行为管理规定
来源：医药网 2020.01.06
1月2日，国家卫健委发布《医疗机构内部价格行为管理规定》，并将自发布之日起施行。《规定》提出，各医疗机构应到建立由多部门组成的价格管理体系。《规定》要求，医疗机构应配备一定数量医疗服务价格工作人员，用于定期检查患者花费，纠正医院不规范收费；各医疗机构应建立医疗服务成本测算和成本控制管理制度，同时公示常用医疗服务项目的价格。
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。[:]
97 negotiations targeted drugs will be published on the internet (National Negotiation)
On December 16th, the NHSA and the National Health Commission jointly issued the “Notification on Ensuring the Usage and Supply of Drugs that are Targeted in the National Negotiation.” The “Notification” stipulated that provincial healthcare security administrations should publish the 97 negotiations targeted drugs on their centralized procurement platform and their new reimbursement drug lists. Besides, healthcare departments should regulate the usage and supply of these drugs and instruct medical institutions to reserve and use them properly according to functions, clinical requirements, and healing effects.
两部门发文：97个国家谈判药品按时直接挂网
来源：医药网 2019.12.18
12月16日，国家医保局、国家卫健委联合发布《关于做好2019年国家医保谈判药品落地工作的通知》。《通知》要求，各省级医保部门应在规定时限内将97个谈判药品在省级药品集中采购平台上直接挂网，并保证新版目录及时落地。此外，各地医保和卫生部门应对谈判药品的配备及使用等方面提出具体要求，并指导各定点医疗机构根据功能定位、临床需求、和诊疗能力等即时配备、合理使用。
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。