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Schlagwort: ‘Drug Codes’

A unified national insurance standardized​ system will be established

November 8th, 2019 | by

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

October 8th, 2019 | by

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

July 11th, 2019 | by

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

July 11th, 2019 | by

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

June 19th, 2019 | by

Recently,  Anhui Human Resources and Social Security issued the “2018 version of Anhui Basic Medical Insurance, Work Injury Insurance and Drug List of Maternity Insurance”, 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

May 4th, 2018 | by

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。

A tracing system for the distribution of Chinese medicine went online in Hubei

February 10th, 2017 | by

On 28th December, a tracing system for the distribution of Chinese medicine went online at the modern logistics center of Dongxihu in Hubei. The tracing system relies on the information technology and the Internet of Things technology. Customers can use smartphones, internet or terminals and scan the electronic tag on the packages of Chinese medicine products, so that all the distribution information (planting, manufacturing and distributing) can be tracked. The establishment of this system can avoid fake products. (Source: cnhubei.com)

湖北省中药材流通追溯体系正式上线

来源:荆楚网 2016-12-29

核心提示:今年12月28日,湖北省中药材流通追溯体系在东西湖现代物流中心正式上线运行。该追溯体系依赖信息技术和物联网技术,消费者可以通过手机、互联网、药店终端等方式,扫描中药材产品包装袋上的唯一电子标签,在任何时间、地点,了解到所购买中药材从种植、加工到流通环节的全流程情况。该体系的建立可以从根本上杜绝假冒伪劣、制假售假的行为。

Three national standards for Chinese medicine codes were implemented in six pharmaceutical companies

January 31st, 2017 | by

On 21st December, a press conference was held in Shenzhen, Guangdong. The occasion was the one-year anniversary of three national standards, including “Chinese medicine coding regulations”. It is said that three national standards (“Chinese medicine formulae coding regulations”, “Chinese medicine regulations”, and “codes and indications of Chinese medicine in the supply chain management”) were already implemented in six Chinese medicine manufacturers in Shenzhen. Through the identification of Chinese medicine, a third-party platform and an evaluation system were created; QR codes were offered for scanning; a tracing system was being built up step by step; a safeguard mechanism of drug safety was built up. (Source: China News of Traditional Chinese Medicine)

3项中药编码国家标准率先在六家药企中实施

来源:中国中医药报 2016-12-22

核心提示:12月21日,广东深圳举行《中药编码规则及编码》等3项国家标准实施一周年新闻发布会。据悉,《中药方剂编码规则及编码》《中药编码规则及编码》《中药在供应链管理中的编码与表示》3项国家标准已先后在深圳市中医药企业标准联盟首批6家中药生产企业实施应用。通过中药认证和标识活动,深圳市建立第三方平台、评价体系,提供二维码扫描,逐步构建追溯体系,形成质量倒追机制,推动企业转型升级,保障药品供应、临床用药安全有效,在全国率先建立药品安全保障机制。

Integration of Ali Health and Tmall Pharmacy – preparing for the market of health care products

October 18th, 2016 | by

On 9th October, the first cooperation after the integration of Ali Health and Tmall Pharmacy came out – the brand “Nutritious China” was released in the industry of health care products. Tagging health care products with high quality, this brand collaborates with many regional governments, companies and industrial associations. Meanwhile, with the help of the drug code tracing platform, Ali Health sets up a “Nutritious China Tracing System” to make every single item of the health care products traceable by the code. Kang Kai, the director of Ali Health and the general manager of the healthcare department of Tmall Pharmacy said that Tmall Pharmacy would adjust the business according to the development. There will be developments in depth on the basis of online selling model, including pharmacist consulting. (Source: 21st Century Business Herald)

阿里健康整合天猫医药馆 “卖药”叫停后布局保健品市场

来源:21世纪经济报道 2016-10-11

核心提示:10月9日,阿里健康与天猫医药馆整合后首次亮相,并针对中国滋补品行业推出转型升级品牌“滋补中国” ,与各地政府、品牌企业、行业协会合作,给高品质的道地滋补品打上了标签。同时,阿里健康还借助其“码上放心”平台,建立“滋补中国追溯体系”实现对相关滋补品“一品一码”的追溯。阿里健康董事、天猫医药健康事业部总经理康凯表示,天猫医药馆会根据业务发展进行相应调整,在天猫售卖平台模式的基础上向纵深发展,不仅有药品还有保健品、药师咨询等。

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10月9日,阿里健康与天猫医药馆整合后首次亮相,并针对中国滋补品行业推出转型升级品牌“滋补中国”。这意味着双方就“重大业务部门保健食品、膳食营养补充食品及传统滋补营养品业务”注入阿里健康的探讨已具体落地。

阿里健康董事、天猫医药健康事业部总经理康凯向21世纪经济报道记者表示,天猫医药馆会根据业务发展进行相应调整,在天猫售卖平台模式的基础上向纵深发展,不仅有药品还有保健品、药师咨询等。

今年初阿里健康主营业务电子监管码和天猫医药馆作为第三方药品零售平台被双双叫停。在业界看来,如今阿里健康与天猫医药馆的整合,对双方都是互赢。阿里健康获得了营收保障,而天猫医药馆作为阿里健康整个大旗舰上面一个很重要的组成部分运作,将获得更多发展。

布局保健品市场

10月9日,阿里健康联合天猫医药馆共同推出的“滋补中国”品牌计划,与各地政府、品牌企业、行业协会合作,给高品质的道地滋补品打上了标签。同时,阿里健康还借助其“码上放心”平台,建立“滋补中国追溯体系”实现对相关滋补品“一品一码”的追溯,目前,已有天士力(600535,股吧)、百花数十家企业确定参与其中。

“提供滋补品全生命周期的追溯服务,展现源头信息等,让消费者可以看到滋补品种植基地的天气情况、土壤湿度和温度、采收状况、加工过程和成品储存等相关信息,并且每个环节都配有相关图片和负责人姓名等详细资料,从而让消费者获得更多知情权。” 康凯介绍说。

同时,康凯还表示,除了正常入驻天猫的相关费用外,天猫医药馆并不会向企业专门就入围“滋补中国”计划收费,并且此后的相关品牌营销费用,按照具体项目与企业共同分担,阿里健康追溯体系“码上放心”也并不强制绑定企业。

据了解,“滋补中国”计划首期引进18个战略合作品牌,10大滋补品产地,并期望用2至3年时间实现10亿元的线上交易额。目前有资格申请入围“滋补中国”计划的有两个方向,一是老字号品牌,另一个是滋补品道地产地,该原产地本身经过国家或当地政府认定的,如三江源的冬虫夏草。

阿里健康CEO王磊向21世纪经济报道记者表示,“滋补中国”是天猫医药纳入阿里健康生态后,针对中国滋补品行业转型升级所推出的首个品牌战略,并且希望通过一系列标准设立,辅之以严格的落实与监管举措,帮助滋补品行业回归健康发展轨道。

王磊指出,近年来滋补品市场增速较快实际是消费升级的需求,另一方面很多滋补品也是一种文化的传承如阿胶等,但滋补品市场亦是乱象丛生,如虫草,屡有喷水、胶合、加面粉乃至金属粉的造假报道,鹿茸、灵芝、雪蛤、人参等也相继被曝存在安全隐患。

浙江省乐清市农业局党委书记兼局长章显岳向21世纪经济报道记者举例称,国内石斛品种有78种,乐清产的铁皮石斛是石斛品质最好的品种之一,价格也很高,但经常被其他石斛甚至被几十元一斤的水草冒充。

北京同仁堂(600085,股吧)健康副总裁王继亮坦言,之所以积极加入“滋补中国”,是想借助阿里健康、天猫医药馆等拥抱互联网进行转型升级,应对电子商务对传统实体销售模式的冲击。

阿里健康整合天猫医药馆

从阿里健康“滋补中国”计划看,天猫医药馆在拓展保健品业务。有业内人士猜测,保健品或是天猫医药馆新的增长品类。

对此,康凯对21世纪经济报道记者表示,滋补品和保健品本来就是天猫医药馆份额相当大的销售品类,这个计划只是想把行业规范起来,并不靠它赚钱。“天猫医药馆会根据业务发展进行相应调整,在天猫售卖平台模式的基础上,向纵深发展,不仅有药品还有保健品、药师咨询等。”

不过,多位业内资深人士认为,往保健品方向纵深发展,实际也是因为医药销售受国家政策影响很大,未来发展方向不确定所致。而保健品市场近年来增长较为稳定,同时保健品由备案制改为注册制亦是利好保健品行业的发展。

不久前,作为第三方药品网售试点已结束,包括天猫医药馆在内的电商平台于2016年8月1日停止了药品在线交易功能,这在一定程度上给平台和商家的销售额均带来了冲击。

据某制药网统计显示,天猫医药馆8月OTC药品类目TOP30品牌交易均出现下滑,并指出其中一个重要原因,即平台运营模式变化带来的体验改变,回归作为药品信息的展示平台,不直接进行药品销售而导致OTC药品类目的交易出现下滑。

而阿里健康在今年初亦遭遇了“危机”,贡献绝大部分利润的电子监管码被国家食药监总局叫停,而收购天猫医药馆的业务又受挫于政策、资金等问题,业界一度担忧其营收来源。

不过,在阿里健康获得天猫医药馆独家运营权后,让阿里健康在流量上挺直腰板,对药店终端也将更有号召力。

业内人士表示,此次阿里健康获得天猫医药馆的独家运营权,一方面缓解了因失去药品电子监管码后没有收入来源的窘境,另一方面实际上通过变通的方式推进了此前阿里健康对天猫医药馆收购无法落地的现实,使得政策、资金带来的风险大大降低,同时,阿里健康获得了基于天猫医药馆优质资源一展拳脚的机会,总体而言,利好阿里健康。

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CFDA published the suggestions for improving the tracing system for food and drug manufacturers

September 30th, 2016 | by

On 27th September, China Food and Drug Administration (CFDA) published the suggestions for improving the tracing system for food and drug manufacturers. Enterprises are encouraged to collect and keep production and management information through informationized ways. CFDA requires that manufacturers and distributors should be able to trace the sources and whereabouts of their food and drugs. When any problems relating to the quality happen, the related products should be able to be traced in time. It is especially mentioned in the opinions that all levels of FDA should not force manufacturers to accept any tracing service from any specified professional technology enterprises. (Source: The paper)

食药监总局发布食品药品生产经营者完善追溯体系意见

来源:澎湃新闻网 2016-09-28

核心提示:9月27日,国家食品药品监督管理总局官网发布了《总局关于推动食品药品生产经营者完善追溯体系的意见》。《意见》表示,按照国家建立追溯制度,企业建立追溯体系,鼓励企业采用信息化手段采集、留存生产经营信息的工作原则,进一步完善食品药品追溯体系。食药监总局要求生产经营者对其食品药品来源可查,去向可追。在发生质量问题时,能够及时找回相关产品并查寻原因。意见特别提到,各级食品药品监管部门不得强制要求食品药品生产经营者接受指定的专业信息技术企业的追溯服务。

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9月27日,国家食品药品监督管理总局(下称“食药监总局”)官网发布了《总局关于推动食品药品生产经营者完善追溯体系的意见》(下称“意见”),对推动食品药品追溯体系提出了八条具体意见。

食药监总局要求生产经营者对其食品药品来源可查,去向可追,在发生质量问题时,能够及时找回相关产品并查寻原因。

意见特别提到,各级食品药品监管部门不得强制要求食品药品生产经营者接受指定的专业信息技术企业的追溯服务。

这也是食药监总局对药品电子监管码引发争议后的矫正措施。

9月27日发布的《意见》表示,按照国家建立追溯制度,企业建立追溯体系,鼓励企业采用信息化手段采集、留存生产经营信息的工作原则,进一步完善食品药品追溯体系。

意见指出,食品药品生产经营者应当承担起食品药品追溯体系建设的主体责任,实现对其生产经营的产品来源可查、去向可追。在发生质量安全问题时,能够及时召回相关产品、查寻原因。

对于食品生产者,意见要求,原则上,食品生产经营者均应采用信息化手段建立追溯体系。不具备信息化条件的生产经营者,可采用纸质记录等实现可追溯。

对于药品、医疗器械生产企业,应当按照其生产质量管理规范(GMP)要求对各项活动进行记录。记录应当真实、准确、完整和可追溯。

食药监总局的意见还指出,要鼓励药品、医疗器械生产企业对产品最小销售单位赋以唯一性标识,以便经营者、消费者识别。植入性医疗器械应当标记生产企业名称或商标、批代码(批号)或系列号,以保证可追溯。

而对于化妆品的追溯体系建设,该意见指出,化妆品生产企业应当按照《化妆品卫生监督条例》等有关法规规定,确保产品生产、质量控制等活动可追溯,并记录产品进入流通环节的流向信息,实现产品去向可查、问题产品及时召回。

意见还对风险程度较高的化妆品作了具体要求,化妆品生产经营者应当以进口化妆品、国产特殊用途化妆品、儿童化妆品等风险程度较高的产品为重点,推进追溯体系建设。

意见还鼓励生产经营者运用信息技术建立食品药品追溯体系。鼓励信息技术企业作为第三方,为生产经营者提供产品追溯专业服务。同时强调,各级食品药品监管部门不得强制要求食品药品生产经营者接受指定的专业信息技术企业的追溯服务。

这一措施是对此前引发争议的药品电子监管码的一次矫正。

今年年初,食药监总局因强制推行阿里健康负责运营的药品电子监管码(网),被湖南一药企起诉至法院,并引发了药品电子监管码存废之争

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