Schlagwort: ‘Drug Codes’
Fujian: Controlling online drug sales
Recently, the Fujian Provincial Medical Product Administration issued the “Plan for Controlling Online Drug Sales.” The Program stated that illicit drug recalls and the selling of counterfeit, inferior, and forbidden drugs on the Internet should be severely punished and that illegal online prescription drug sales should be strictly regulated. At the same time, drug retailers should actively track the drugs sold on the internet using the drug code.
福建：开展药品网络销售环节集中治理清网行动
来源：医药网 2024.03.07
近日，福建省药监局印发了《福建省药品网络销售环节集中治理工作方案》。《方案》明确，应严厉打击利用网络渠道非法回收药品、销售假药劣药以及销售禁售药品行为，持续整治处方药网络销售违法违规行为。同时，应积极推进药品零售企业对网络销售药品的扫码追溯。
Anhui: establishing traceability system for Traditional Chinese Medicine
The Anhui Medical Product Administration recently organized a conference on the traceability system for Traditional Chinese Medicine (TCM). During the meeting, a staff member of the administration interpreted related legal documents, particularly the “Coding Standards of the Tracing Code of TCM,” “Labeling Standards of the Tracing Code of TCM,” and “Standards of Code Mapping between Anhui Provincial Traceability Platform of TCM and Information Systems of TCM Manufacturers.” Participating TCM manufacturers addressed the aforementioned standards and provided recommendations for the identification of traceability codes and packaging specifications, data mapping, and data safety. The Anhui Medical Product Administration will consider these suggestions and revise the TCM traceability criteria, advising TCM manufacturers to appropriately reform their information systems for data mapping to the Anhui Provincial Traceability Platform of TCM.
安徽持续推进中药饮片信息化追溯体系建设
来源：中国食品药品网 2023.07.31
近日，安徽省药监局召开中药饮片信息化追溯讨论会。会上，安徽省药监局相关人员解读了中药饮片追溯相关法规文件，重点讲解了《安徽省中药饮片追溯码编码规范（征求意见稿）》，《安徽省中药饮片追溯码标识规范（征求意见稿）》，《安徽省中药饮片信息化追溯平台与企业自建系统数据对接规范（征求意见稿）》等。与会中药饮片企业围绕上述规范展开研讨，针对追溯码产品标识、包装规格标识以及数据对接、数据安全等问题提出意见建议。结合企业提出的意见建议，安徽省药监局将进一步完善中药饮片信息追溯相关规范，指导企业对照规范适当改造自建系统与安徽省中药饮片信息化追溯平台进行数据对接。
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。
Shandong: issuing the Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises
Recently, the Shandong Provincial Drug Administration issued “Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises in Shandong Province.” The Guiding Principles will be in effect by February 1, 2023 and will be valid until January 31, 2026. According to the Guiding Principles, the traceability system should adhere to the NMPA’s technical standards for data exchange and gradually achieve interconnection with provincial, extra-provincial, and national data platforms. The traceability system should establish three major traceability modules: traceability modules of the raw materials of Chinese medicine tablets, traceability modules of the production quality of Chinese medicine tablets, and traceability models of the circulation and use of Chinese medicine tablets. In addition, the Guiding Principles standardize the composition of the traceability code, which should include information such as the name of the manufacturer, the batch number, the packaging specifications, and the date of production.
《山东省中药饮片生产企业信息化追溯体系建设指导原则》发布
来源：山东省人民政府 2023.01.06
近日，山东省药监局印发《山东省中药饮片生产企业信息化追溯体系建设指导原则》。《指导原则》自2023年2月1日起施行，有效期至2026年1月31日。《指导原则》指出，追溯系统应符合国家药监局制定的数据交换技术标准，逐步实现与省内、省外和国家数据平台的对接。追溯系统应建立中药饮片原材料信息追溯、中药饮片生产质量信息追溯和中药饮片流通使用信息追溯三大信息化追溯模块。另外，《指导原则》规范了追溯码的基本构成，追溯码应包含生产企业名称、饮片批号、包装规格、生产日期等信息。
Changchun: promote the development of the drug traceability system
Since this year, the Market Supervision Bureau of Changchun City, Kuancheng Branch, has urged pharmacies to register in the “Mashangfangxin” drug traceability platform and upload drug tracability data. Through drug warehousing and sales, drug tracability data will be collected so that the purchase, sales, and inventory of drugs can be checked to ensure drug safety.
吉林省长春市宽城区推进药品信息化追溯体系建设
来源：国家重要产品追溯体系 2022.07.27
今年以来，吉林省长春市市场监管局宽城分局督促药店入驻“码上放心”药品追溯平台并在平台上传药品数据，并通过药品入库验收、销售出库等环节收集到的药品追溯信息核对药品进销存情况。
Guangxi: A Platform to promote the traceability of drugs
Recently, the market supervision administration of Liuzhou City, Guangxi Province, promoted the development of a drug traceability supervision platform. This plan comprises three steps. First, the Market Supervision Administration should conduct centralized interviews with city chain pharmacies, subordinate retail enterprises, and single pharmacies, and elaborate on the significance and positive impact of joining the drug traceability supervision platform, which is designed to ensure drug safety and quality. The second step is to communicate with the city’s retail pharmacies and encourage them to join the drug traceability supervision platform as soon as possible. Third, the drug traceability supervision platform should be aggressively promoted to the general public, and the general public should be guided to independently check the entire process’s tracing data of drugs in order to give the public a possibility to independently check the quality of drugs along the whole drug distribution chain.
让群众购药“码上放心”！广西省柳州市市场监督管理局全力推进药品溯源监管平台工作
来源：中国质量新闻网 2022.01.26
近日，广西省柳州市市场监督管理局全面推进建设药品溯源监管平台工作。一是对全市连锁药店及下属零售企业、单体药店开展集中约谈，阐述登陆药品溯源监管平台对保障药品安全质量的重要性和积极效果。二是与全市各零售药店进行及时沟通，督促企业尽快入驻药品溯源监管平台。三是向社会公众大力宣传药品溯源监管平台，引导群众自主查验药品信息化的全过程追溯数据，实现从零售终端回溯到生产的全过程质量查询。
Shanxi: Establishing a Drug Tracing System
Recently, the Shanxi Provincial Medical Product Administration issued the “Working Plan on Establishing Drug Information Tracing System,” which concerns the development of a framework for a drug tracability supervision system by the end of 2020. The “Plan” stipulates that drug manufactures should build their own or use a drug information traceability system established by a third-party platform to share information with the national collaborative drug traceability platform and realise the tracing of special drugs such as narcotic drugs and psychotropic drugs and selected drugs in the provincial centralised procurement.
山西省药监局出台《药品信息化追溯体系建设工作方案》
来源：新浪新闻 2020.12.04
近日，山西省药监局出台《药品信息化追溯体系建设工作方案》，计划到2020年底将完成山西省药品追溯监管系统基础开发。《方案》要求，药品生产企业应自建或选用第三方平台建立的药品信息化追溯系统，并完成和国家药品追溯协同服务平台的数据对接，基本实现麻醉药品、精神药品等特殊药品以及集中采购中标品种的全过程追溯。
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。
Coding rules for chinese traditional drugs
On September 25th, the NMPA issued the “Coding Rules of Chinese Traditional Drugs Included in the Reimbursement List and Pharmaceutical Preparations of Medical Institutions.” The code of Chinese traditional drugs consists of 10 digits and four sections. The first section represents Chinese traditional drugs. The second section represents different medical standards in different cities. The third section represents drug effects. The fourth section represents the name of drug. The code of pharmaceutical preparation of medical institutions consists of 16 digits and 4 sections. The first section represents pharmaceutical preparations. The second section represents different medical institutions in different cities. The third section represents medical institutions. The fourth section represents the sequence of pharmaceutical preparations in different medical institutions.
医保药品中药饮片和医疗机构制剂统一编码规则和方法
来源：医药网 2020.09.27
9月25日，国家医保局印发了《医保药品中药饮片和医疗机构制剂统一编码规则和方法》。中药饮片分为4个部分共10位。其中，第1部分是中药饮片识别码，第2部分是标准分类码，第3部分是功效分类码，第4部分是中药饮片名称码。医疗机构制剂编码分4个部分16位。其中，第1部分是医疗机构制剂识别码，第2部分是行政区划代码，第3部分是定点医疗机构顺序码，第4部分是医疗机构制剂顺序码。
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。