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Schlagwort: ‘Drug Codes’

Shandong: issuing the Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises

January 6th, 2023 | by

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

July 27th, 2022 | by

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

January 26th, 2022 | by

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

December 4th, 2020 | by

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

October 14th, 2020 | by

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

September 27th, 2020 | by

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

April 23rd, 2020 | by

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

March 12th, 2020 | by

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

December 2nd, 2019 | by

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。

Catalog of medical insurance (2019 Version) is released

August 21st, 2019 | by

On August 21st, the State Council issued the “National Medicine Catalogue of Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance (2019 version),” which will be implemented from January 1st, 2020. The “Medicine Catalogue” Indicates that each provincial Medical Insurance Bureau should bring all the drugs of the “Medicine Catalogue” into the “Centralised Procurement” and update the drug database according to the use of drugs in local medical institutions and retail pharmacies. Meanwhile, a national unified drug database should be established to realise the unified management of codes of western medicine, Chinese traditional medicine, and hospital-made medicines.

2019版国家医保目录正式发布

来源:医药网 2019.08.21

8月21日,国务院发布《国家基本医疗保险、工伤保险和生育保险药品目录》(以下简称《目录》),并自2020年1月1日起开始实施。《目录》要求,各省级医疗保障部门应及时将《目录》内药品纳入当地药品集中采购范围,并根据辖区内医疗机构和零售药店药品使用情况,及时更新完善药品数据库。同时,应建立完善全国统一的药品数据库,实现西药、中成药、中药饮片、医院制剂的编码统一管理。