Kategorie: ‘Pharmaceutical Company News’
Developing evaluating systems of drug pricing and bidding and procurement performence
On September 16th, the NHSA offically issued the “Guidelines on Establishing a Evaluating System of Drug Pricing and Bidding and Procurement Performence,” which stipulates that each province should establish and launch their own system before the end of 2020. The “Guidelines” clarifies that centralised procurement organizations of drugs and medical equipments should prevent pharmaceutical companies from fixing unreasonable drug price, such as via giving kickback to hospitals. At the meantime, the pharmaceutical companies that do not act properly will be documented and punished according to different levels of dishonesty while they are also encouraged to rectify to regain their credit score.
医保局：医药价格和招采信用评价年底前落地！
来源：医药网 2020.09.17
9月16日，国家医保局官网正式发布了《关于建立医药价格和招采信用评价制度的指导意见》（以下简称《意见》），要求各地于2020年底前建立并实施医药价格和招采信用评价制度。《意见》明确，药品和医用耗材集中采购机构应采取措施制止医药企业给予回扣等不合理定价行为。同时，应记录失信医药企业信息，根据不同失信等级采取不同处置措施，并鼓励企业整改，主动修复信用。
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。
Hospitals and pharmacies should pay the drug cost within 30 working days
On May 12th, the NMPA issued the “Notification on Issuing the List of National Medical Security Management Services.” The “Notification” stipulates that medical institutions including hospitals and pharmacy chains should pay the drug cost for distributors and manufacturers within 30 working days.
国家医保局：定点医院、药店费用结算时限不超过30个工作日
来源：医药网 2020.05.13
5月12日，国家医保局发布《关于印发全国医疗保障经办政务服务事项清单的通知》。《通知》明确，定点医疗机构（含医疗机构、零售药店）费用结算办理时间应不超过30个工作日。
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。
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。
Supervising the drug price and investigating the cost price
On December 6th, the National Medical Insurance Bureau issued the “Opinions on Supervising the Drug Price.” The “Opinion” indicated that a pricing system that depends on the market should be encouraged, and the centralised procurement with defined quantities, of which the drug price depends on the quantities and the bidding process combines with the procurement, should be further implemented. The “Opinion” also stipulated that a pre-warning system of abnormal drug price movements and an investigation system of the cost price of drugs should be established as well.
国家医保局发布文件：监管药品价格 调查成本
来源：医药网 2019.12.09
12月6日，国家医保局发布《关于做好当前药品价格管理工作的意见》（以下简称《意见》）。《意见》指出，坚持市场调节药品价格的总体方向；坚持“带量采购、量价挂钩、招采合一”的方针。《意见》要求，应建立价格供应异常变动监测预警机制，并完善药品价格成本调查工作机制。
Online drug selling is being supervised
Recently, the National Development and Reform Commission and Ministry of Commerce jointly issued the “Negative List of Market access (2019 version),” which proposed that drug production and trading companies are not allowed to sell prescription drugs directly to the public through mail or internet trade.
网络售药行为进一步规范，邮寄处方药全面叫停
来源：制药网 2019.11.23
日前，国家发改委、商务部联合发布《市场准入负面清单（2019年版）》。其中明确提出：“药品生产、经营企业不得违反规定采用邮寄、互联网交易等方式直接向公众销售处方药。”
Improving the supply system of shortage medicines
Recently, the General Office of the State Council issued the “Guiding Opinions on Maintaining the Price and Supply of Shortage Medicines.” The “Guiding Opinion” stipulated that a national multi-source information collection platform for shortage medicines and a monitoring system for this platform should be established to realise information sharing of APIs (Active Pharmaceutical Ingredient) and pharmaceutical preparations in terms of their registration, production, procurement, and price. As for the drugs in the shortages list, pharmaceutical enterprises are allowed to quote their price on the provincial-level centralised drug procurement platform or on the internet so that medical institutions can purchase them on demand.
国办：强化药品价格常态化监管 完善短缺药品供应体系
来源：医药网 2019.10.14
近日，国务院办公厅印发《关于进一步做好短缺药品保供稳价工作的意见》（以下简称《意见》）。《意见》指出，应建立国家短缺药品多源信息采集平台和协同监测机制，实现原料药和制剂在注册、生产、采购、价格等方面的信息联通共享；对于短缺药品清单中的品种，允许企业在省级药品集中采购平台上自主报价、直接挂网，医疗机构自主采购。
“Prescription Sharing” supported
On September 29th, 21 commission and administrations, including the National Development and Reform Commission, the National Healthcare Security Administration, the National Health Commission, the National Medical Product Administration, jointly issued the “Guideline of Promoting a High-quality Development of the Health Industry (2019-2022).” The “Guideline” stipulated that channels for the interconnection and real-time sharing of information on drug consumption and on prescriptions of online diagnosis and treatment should be established nationwide. In the meantime, third-party platforms are suggested to deliver online prescribed drugs to encourage Medical e-commerces to offer “ordering online and delivered offline” services.
21部门发文力挺处方外流
来源：医药网 2019.09.30
9月29日，国家发改委、国家医保局、国家卫健委、国家药监局等21部委联合发布《促进健康产业高质量发展行动纲要（2019-2022年）》（下称“行动纲要”）。《行动纲要》要求，各地应建立互联网诊疗处方信息与药品零售消费信息互联互通、实时共享的渠道；支持在线开具处方药品的第三方配送；加速医药电商发展向患者提供“网订（药）店取，网订(药)店送”等服务。