Schlagwort: ‘Drug Supply Chain’
The State Council: establishing a national drug traceability collaboration platform
Recently, the State Council issued the “Opinions on Strengthening Drug Supervising Capacity.” The “Opinion” stipulates that the traceability information system be enhanced and a national drug traceability collaboration platform be established to achieve complete drug tracking and tracing and to gradually apply unique identification for medical devices.
国办：构建全国药品追溯协同平台，实现全周期追溯
来源：医药网 2021.05.11
日前，国务院办公厅印发《关于全面加强药品监管能力建设的实施意见》。《实施意见》提出，应完善信息化追溯体系，构建全国药品追溯协同平台，实现药品全生命周期追溯，逐步实施医疗器械唯一标识。
New regulations of online drug trading
On November 12th, the NMPA issued the “Measures for the Supervision and Regulation of Online Drug Trading (Consultation Paper).” The paper clarifies that drug trading enterprises can only sell drugs that are allowed to be sold; special drugs such as vaccines, anesthetics and psychotropic drugs are not allowed to be traded online. The paper also indicates that drug trading enterprises that are allowed to sell prescription drugs online should check the source of electronic prescription and the dispensing in the prescription and mark the used prescription. Moreover, drug trading enterprises should provide online medical services and employ pharmacists to guide the public to use drug rationally.
药品网售新规来了：不得销售麻醉、精神药品等
来源：医药网 2020.11.13
11月12日，国家药监局公布《药品网络销售监督管理办法（征求意见稿）》。《意见稿》明确，药品网络销售不得超出企业经营方式和药品经营范围；疫苗、麻醉药品、精神药品等特殊药品不得通过网络销售。《意见稿》指出，具备网络销售处方药条件的药品零售企业应检查电子处方来源，审核处方调剂，并对已使用的处方进行电子标记；在销售同时，应当建立在线药学服务制度，配备执业药师，指导合理用药。
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。
Hainan: supervising the drug procurement process
On October 10th, the Hainan Medical Insurance Bureau issued the “Plan on Supervising and Evaluating the Medical Price in Hainan Province.” The “Plan” clarifies that drugs included in the procurement list on the website of the centralised procurement platform of Hainan Province should be supervised, which means that monitoring and early warning systems will be implemented as drugs are published on or removed from the website as well as during the processes of drug procurement, distribution, use, and purchase. In addition, a centralised drug procurement assessment for medical institutions should be developed, in which will be evaluated particularly whether medical institutions have obeyed the purchase agreement and paid for the drugs with in 30 days, the rate of drug cost compared with the whole medical costs in medical institutions, the rate and purchasement of unselected drugs, and illegal purchase behavior.
医保局推药品采购全流程监测预警！严抓30天回款率
来源：医药网 2020.10.12
10月10日，海南省医疗保障局印发《海南省医药价格综合监管评价服务工作方案》（以下称《工作方案》）。《工作方案》明确，将在海南省医药集中采购平台挂网采购的药品纳入监测内容，对药品的挂网、撤网、采购、配送、使用和回款等全流程实施监测预警。 另外，应设置医疗机构的药品集中采购考核，其中对于协议完成率、30天汇款率、药占比、非中选产品采购量及金额占比、违规采购行为等进行了重点评分规定。
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。
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。
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。
Establishing a nationwide unified procurement platform of drugs
On November 29th, the National Health Commission issued the “Notification on Measures of Deepening the Reform of the Medical and Healthcare System depending on the Centralised Procurement and Use of Drugs.” The “Notification” emphasised that a nationwide unified procurement platform based on provincial centralised procurement platforms should be established, in which the drug codes and procurement standards should be unified so that the drug price can be linked together nationwide. In addition, corporate groups, integrated healthcare organisations, private medical institutions, and pharmacies are encouraged to implement centralised procurement to develop a pricing system that depends on the market. The “Notification” also stipulated that the medical insurance administrative agencies instead of hospitals should pay for the drugs to manufacturers and distributors directly.
医药行业变革：建设全国采购平台 全国价格联动
来源：医药网 2019.12.02
11月29日，国家卫健委体制改革司发布《国务院深化医药卫生改革领导小组印发关于以药品集中采购和使用为突破口进一步深化医药卫生体制改革若干政策措施的通知》。《通知》强调，应依托省级集中采购平台构建全国公共采购市场，统一编码、标准和功能规范，推进价格等相关信息互联互通，促进全国价格联动；鼓励探索集团采购、医联体采购等方式形成合理价格，鼓励非公立医疗机构、社会药店等积极参与，共同推动形成以市场为主导的药品价格形成机制；《通知》还要求，应由医保经办机构直接与生产或流通企业结算药品货款。