Schlagwort: ‘Drug Codes’
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。
Catalog of medical insurance (2019 Version) is released
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。
“Guideline” for “Internet+Health Care” in Shandong province released
On July 11th, the Shandong Provincial Government issued the “Notification on the Construction Plan for Promoting a Demonstration Province of ‘Internet+Health Care’ from 2019 to 2020.” The “Notification” stipulates that to achieve the real-time exchange and sharing of medical data, the construction of a “traceability system of drugs,” a “pre-warning and detecting system of medicines in short supply,” and a “prescription circulation platform” should be promoted. The “Notification” indicates that the construction of “Internet Hospitals” based on medical institutes is encouraged, and the “consulting or prescribing medicine over the internet” should be widely implemented in Shandong province from 2020.
山东“互联网+医疗健康”的路线图， 来了！
来源：医药网 2019.07.15
核心提示：7月11日，山东省人民政府发布《关于印发山东省推进“互联网+医疗健康”示范省建设行动计划（2019-2020年）的通知》（以下简称《通知》）。《通知》指出，应加快药品追溯体系、短缺药品检测预警系统以及处方流转平台的建设，实现医疗数据的实时交换和共享。《通知》明确，鼓励建设依托医疗机构发展的互联网医院，2020年起应普遍开展互联网诊疗服务。
A unified national insurance standardized system will be established
On June 27th, the National Health Security Administration(NHSA) issued the “Guideline on the Standardisation of Medical Security.” The “Guideline” indicates that the exchange of medical security information in China has begun to use a common language——the “Coding Standard.” Now, the NHSA has completed four “Coding Standards”. Among them, the “Code and Classification of Medical Insurance Drugs” covers all drugs approved by the NMPA and realizes “one-code-for-one-drug”, which makes it easier for the public to inquire about drug information and provides resource sharing. The “Guideline” also indicates that the NHSA will focus on the standardization of medical insurance funds, medical price management, the medical security system and so on.
建立全国统一医保标准化体系
来源：医药网 2019.06.28
核心提示：6月27日，国家医保局印发《医疗保障标准化工作指导意见》。《意见》指出，我国医疗保障信息交换已经开始使用通用语言——业务编码标准。目前，医保局已经完成了四项编码标准。其中，“医保药品分类与代码”覆盖了经药品监督管理部门批准上市的全部药品，实现了“一物一码”，可便于公众查询以及提供资源共享。《意见》还表明，国家医保局将在医保基金、医药价格管理、医疗保障系统等方面重点实行标准化。
The State issued two construction standards of the information-based traceability system of drugs
Recently, the National Medical Products Administration issued the “Guideline on the construction of an information-based traceability system of drugs” and the „Requests for the coding of the drug traceability code,” which will be implemented since the release date. The “Guideline” indicates that the information-based traceability system should contain a drug traceability system, a collaborative service platform, and a regulatory system. Besides, it should also include the traceability information in the whole process of drug production, circulation, and use, and it fulfils the function of collecting, storing, and sharing the traceability information. The system can be divided into two categories: self-built traceability system of enterprises and traceability system provided by third-party institutions.
两项药品信息化追溯体系建设标准出炉，保证药品信息安全
来源：制药网 2019.05.06
核心提示：日前，国家药监局发布了《药品信息化追溯体系建设导则》（以下简称《导则》）和《药品追溯码编码要求》两项信息化标准，并于发布日起实施。《导则》指出，药品信息化追溯体系应包含药品追溯系统、药品追溯协同服务平台和药品追溯监管系统。同时，还应包含药品在生产、流通及使用等全过程追溯信息，并具有对追溯信息的采集、存储和共享功能，可分为企业自建追溯系统和第三方机构提供的追溯系统两大类。
Fujian encourages the implementation of electronic first transaction information of drugs
On October 10th, Fujian Food and Drug Administration published “Notification on encouraging drug production and management enterprises to implement electronic first transaction information of drugs”. The “Notification” indicates that pharmaceutical enterprises and medical institutes are encouraged to use the Internet to establish a drug traceability system and an electronic exchange platform for the first transaction information. The “Notification” also stipulates that the platform should comply with the relevant national laws and regulations, and undertake the corresponding legal responsibility.
福建鼓励实施药品首营资料电子化
来源：中国医药报 2018.10.12
核心提示：10月10日，福建省食品药品监管局印发《关于鼓励药品生产经营企业实施药品首营资料电子化的通知》（以下简称《通知》）。《通知》指出，鼓励药企及医疗机构运用互联网建立药品追溯体系和首营资料电子化交换平台。《通知》要求，平台应符合国家相关法律法规规定，并承担相应的法律责任。
The electronic drug regulation will be recommissioned
On August 24th, 2018, the State Food and Drug Administration issued “Guiding Opinions on the Construction of a Drug Information and Traceability System (consultation paper)”. The “Guiding Opinion” stipulates that licensed sellers of drugs and pharmaceutical enterprises should each establish their own traceability system. The ownership of the drug traceability data is determined by the principle “who generated, who owns”. It encourages Holders, pharmaceutical enterprises, users, industry associations, third-party service agencies, and administrative departments to implement the interconnection of drug information traceability through the drug traceability collaborative service platform.
国家药监局: 重启药品电子监管
来源：医药网 2018.08.27
核心提示：8月24日，国家药监局发布《关于药品信息化追溯体系建设的指导意见（征求意见稿）》（下称《意见》）。意见要求，药品上市许可持有人和药企应自建追溯系统；药品追溯数据的所有权为“谁产生、谁所有”；鼓励持有人、药企、使用单位、行业协会、第三方服务机构、行政管理部门通过药品追溯协同服务平台实现药品信息化追溯各方互联互通。
Anhui: The 2018 version of the medical insurance catalog is released
Recently, Anhui Human Resources and Social Security issued the “Medicine Catalogue of Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance in Anhui Province(2018 version)”, which will be implemented from July, 1st, 2018. The catalog includes 1481 western medicines and 1356 Chinese patent medicines. Anhui Human Resources and Social Security indicates that Anhui Province will use the unified “Drug Catalog” database. The drugs on the catalog will be coded according to the “Social Insurance Drug Classification Code”, which will be confirmed by the provincial medical insurance administrative department.
安徽：2018版医保目录出炉
来源：中国医药报 2018.05.29
核心提示：日前，安徽省人社厅发布《安徽省基本医疗保险、工伤保险和生育保险药品目录2018年版》，将于7月1日起执行。该目录包括西药1481个，中成药1356个。安徽省人社厅表示，安徽省将使用统一的《药品目录》数据库，并按照《社会保险药品分类代码》对目录药品进行对码，由省级医保行政部门进行确认。
First drug tracing service platform based on blockchain went online
In June, 2017, the fist drug tracing service platform based on blockchain – Ziyun drug tracing service platform – went online. It is known that all tracing data from Zhengzhou Aolite Pharmaceutical is saved on the blockchain platform of Ziyun Shares. With the model of “one code for one item” all trancing dates cannot be changed, so that all products from Aolite Pharmaceutical are qualified to pass the quality control in the distribution process. (Source: CFLP)
国内首个基于区块链的药品追溯服务平台上线
来源：中国物流与采购网 2017-06-07
核心提示：日前，国内第一个基于区块链的药品追溯服务平台——紫云药安宝药品追溯云服务平台正式上线。据了解，郑州奥林特药业的追溯数据全部都是保存在紫云股份的区块链平台上，利用“一物一码，码物同追”的模式，所有追溯数据不可篡改，确保奥林特药业产品在流通过程中的质量控制完全合规合格。