Schlagwort: ‘Drug Supply Chain’
Wenzhou: establishing traceability system for Traditional Chinese Medicine
In the context of the “Global Migration to 2D” (GM2D), the Market Supervision Bureaus of Wenzhou City and Cangnan County promote manufacturers of Traditional Chinese Medicines to implement GM2D in the traceability system of TCMs to realize the ‘one-code-one-drug’ tracing of TCMs. In addition, the cultivation of raw materials for TCMs should also be traced to improve the quality and safety of TCMs.
一物一码，物码同追，温州积极探索构建中药饮片过程追溯体系
来源：中国食品药品网 2023.06.13
温州市市场监管局、苍南县市场监管局借助“全球二维码迁移计划”（GM2D）示范区建设，积极推动辖区中药饮片生产企业参与试点，将GM2D应用于中药饮片追溯体系建设，成功实现中药饮片一物一码、物码同追。在达到原药品电子监管码追溯水平的同时，将追溯延伸到种植环节，进一步提高药品质量安全保障水平。
Guangdong: Improve the modern drug distribution system
Recently, the Guangdong Provincial Drug Administration and the Department of Commerce jointly issued a “notice on improving the modern drug distribution system to promote the development of drug distribution.” The Notice proposes that modern logistics standards for drugs should be implemented in Guangdong province to make drug storage and transportation more efficient, cost-effective, standardized, and intelligent. To deliver drugs to both urban and rural areas, an efficient and safe drug distribution system should be established, as well as a cross-regional province-wide drug logistics supply chain. Large drug distributors should be primarily responsible for drug distribution while small and medium-sized drug distributors should support them.
广东加快完善现代药品流通体系，推进药品流通产业高质量发展
来源：医药经济报 2022.07.15
近日，广东省药品监管局和省商务厅联合印发《关于完善现代药品流通体系推进药品流通产业高质量发展的通知》（以下简称《通知》）。《通知》提出，应加快推动出台广东省药品现代物流标准，提升药品储存运输集约化、规范化、智慧化水平；推动完善城乡高效安全配送体系，打造跨区域全省药品物流供应链；加快培育大型现代药品流通骨干企业为主体，中小企业为补充的药品流通格局。
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。