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Schlagwort: ‘Information System’

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。

Bozhou: developing a regional traceability system for traditional Chinese medicine tablets

December 22nd, 2022 | by

Recently, the Anhui Provincial Drug Administration stated that Bozhou city has taken the lead in developing a regional traceability system for traditional Chinese medicine tablets, which has already covered 192 traditional Chinese medicine tablet manufacturers in the city. The traceability system consists of two main parts: the enterprise side and the supervisory side. The enterprise side of the traceability system manages procurement, production, warehousing, finance, sales, and other key aspects of the manufacturing process, allowing for real-time recording of the production process and track modification. The supervisory side can read data from and enter data into the enterprise side traceability platform. The supervisory side can assess enterprise data within its authority at any time and, if necessary, manage drug recalls, conduct intelligent analysis, and post information on the platform, allowing for digital supervision of the quality of traditional Chinese medicine tablets.

亳州率先建设区域性中药饮片信息化追溯体系

来源:搜狐  2022.12.22

日前,安徽省药监局称亳州市在全国率先建设的区域性中药饮片生产信心化追溯体系现已覆盖全市192家中药饮片生产企业。信息化追溯平台系统主要由企业端和监管端两部分构成。企业端追溯系统把控采购、生产、仓储、财务、销售等关键环节过程,能够实现生产全过程的实时记录与修改留痕。监管端可实现从企业端追溯平台自动读取、录入数据。监管部门可根据需要随时查询权限内的企业数据,完成药品的召回管理、智能分析及信息发布等内容,实现中药饮片质量的数字化监管。

Jiangxi: introducing 15 measures to support the development of pharmacy chains

December 2nd, 2022 | by

Recently, Jiangxi province’s Medical Products Administration issued “Opinions on Supporting the Development of Pharmacy Chains.” The Opinions support large-scale drug wholesalers and pharmacy chains to acquire single-pharmacies in various ways; they support pharmacies within the same pharmacy chain to allocate drugs on demand; they support pharmacy chains to provide round-the-clock drug vending machines in public places; they support supermarket chains to sell OTC drugs of class B; they support pharmacy chains to implement remote pharmacy services and prescription review by licensed pharmacists and to establish remote pharmacy service centers; they support e-management of data in pharmacy chains; they encourage pharmacy chains to sell drugs on the internet and to keep prescriptions for patients with chronic diseases.

江西出台15条措施全面支持鼓励药品零售连锁企业发展

来源:江西省药品监督管理局  2022.12.02

近日,江西省药品监督管理局印发了《关于支持药品零售连锁企业发展的意见(试行)》。《意见》指出,重点支持大型药品批发企业、大型药品零售连锁企业集团通过多种形式整合单体药店;支持同一零售连锁企业门店之间按需相互调拨药品;支持药品零售连锁企业在大型公共场所内开设24小时自动售药机;支持连锁超市销售乙类非处方药;支持药品零售连锁企业开展执业药师远程药学服务及审方业务,鼓励药品零售连锁总部设立远程药学服务中心;支持药品零售连锁企业数据电子管理;鼓励连锁企业采用“互联网+”销售方式销售药品,推行慢性病处方留存制度。

Yangtze River Delta region: Promoting multi-regional drug regulatory data sharing

October 24th, 2022 | by

Recently, the Jiangxi Provincial Drug Administration signed a “memorandum of collaboration among drug administration authorities on strengthening digital drug supervision in the Yangtze Delta region” with Shanghai, Jiangsu, Zhejiang, Anhui, and other drug administration authorities in the Yangtze Delta region. Following the signing of the memorandum, the Jiangxi Provincial Drug Administration took the lead in developing the “Standards for the collection and exchange of data in terms of the supervision and production of drugs in the Yangtze Delta region,” which establishes a mechanism for sharing and reusing electronic data in the Yangtze Delta region and effectively promotes data sharing and reuse in terms of drug review and approval, drug production supervision, and credit administration.

江西大力推进长江三角洲区域药品监管一体化建设

来源:大江网  2022.10.24

近日,江西省药监局牵头与上海、江苏、浙江、安徽等长江三角洲地区药品监管部门共同签订《长江三角洲区域药品监管部门协同加强数字药监建设机制备忘录》。该备忘录签订后,江西省药监局牵头起草了《长三角地区药品生产监管数据采集和交换标准》,建立了长三角地区电子数据共享复用机制,有效推动药品审评审批、生产监管、信用管理等电子数据的共享复用。

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。

Hebei: promote the development of pharmacy chains

July 2nd, 2022 | by

Recently, the Hebei Provincial Drug Administration issued “Opinions on Supporting the Development of Pharmary Chains.” The “opinions” advocate the connection between the prescription systems of physical and internet medical institutions and pharmacy chains. The “opinions” encourage pharmacy chains to allow patients with chronic diseases to buy prescription drugs with the same name and specifications in the same pharmacy chain without presenting the prescription if they have previously used this prescription in this pharmacy chain. The “opinions” also encourage pharmacy chains to establish remote prescription review centers to provide remote pharmacy services to patients and review prescriptions for them, which serves as a supplemental service for patients when licensed pharmacists are not on duty or are not at their working hours.

最新!河北出台26项创新举措 助力药品零售连锁企业发展

来源:搜狐网  2022.07.02

日前,河北省药品监督管理局印发《关于支持药品零售连锁企业发展的意见》(以下简称《意见》)。《意见》支持药品零售连锁企业与实体医疗机构、互联网医疗机构的互联互通,实现处方系统与连锁药店的配药无缝对接;支持药品零售连锁企业推行慢性病患者处方留存购药制度;鼓励药品零售连锁总部设立远程药学服务(审方)中心,开展远程药学服务和审方工作,作为执业药师不在岗或者非工作时段的补充服务。

Tianjin: implementing remote drug prescribing

June 10th, 2022 | by

Recently, the Tianjin City Fourth Regulatory Office advised pharmacy chains in their jurisdiction to implement remote drug prescribing. The Regulatory Office explained to pharmacy chains the requirements for implementing remote drug prescribing, as well as the standards that must be met and the concrete steps to be taken. They also evaluated the entire prescribing process, including generating prescription drug orders, initiating remote drug prescribing requests, pharmacist remote review of prescriptions, order confirmation and collection in the remote drug prescribing system, and making suggestions for the prescription process.

第四监管办指导药品零售连锁企业 开展远程药事服务工作

来源:天津市药品监督管理局  2022.06.10

近日,天津市第四监管办积极指导片区药品零售连锁企业开展远程药事服务工作。第四监管办帮助企业熟悉开展远程审方业务的实施条件、标准及具体工作程序,并对远程审方系统处方药销售订单生成、远程审方需求发起、药师审方及确认、销售订单释放及收款的全过程进行检查,并对进一步完善相关功能提出意见。

Shanxi: traceability system for selected drugs

May 13th, 2022 | by

Recently, the Shanxi Provincial Drug Administration issued a “Notice on Further Work on the Construction of Traceability Systems for Selected Drugs.” According to the Notice, all pharmaceutical enterprises must establish a sound drug tracability management standard, as well as build their own drug tracing system in accordance with national standards or use a third-party drug tracing platform. When secondary and tertiary medical institutions warehouse selected drugs, they must provide drug information to upstream distributors and cannot warehouse drugs that do not match their tracability information. When there are problems with drug quality and safety, medical institutions should work with drug manufacturers and upstream suppliers to record and provide information for drug recalls.

山西部署年底实现重点药品全过程可追溯

2022.05.13  来源:国家重要产品追溯体系

近日,山西省药监局发布《关于进一步做好重点品种信息化追溯体系建设工作的通知》。《通知》指出,生产企业和经营企业要建立健全的药品追溯管理制度,按照国家标准自建或者选用第三方平台建立药品信息化追溯系统。《通知》要求,使用重点品种的二级及以上医疗机构在药品入库时将药品信息反馈上游企业,严禁将追溯信息和实物不相符的药品入库。药品出库时应更新药品状态。当发生药品质量安全问题和风险时,各医疗机构应配合药品生产企业及上游供货企业,记录并提供药品召回流向信息。

Hunan: A System to promote the evaluation of adverse drug reactions and efficacy of hospital-made drugs

March 10th, 2022 | by

Recently, the Hunan Provincial Drug Administration, the Human Health Commission, and the Hunan Bureau of Traditional Chinese Medicine jointly issued a “Notice on the Launching of a System for Patient-driven Declaration of Adverse Drug Reactions and the Evaluation of the Efficacy of Hospital-made Drugs.” The Notice stated that beginning on May 1, 2022, hospitals and other medical institutions must download a special QR code for hospital-made drugs through that system and print it in in an obvious position on the instructions, labels, or internal and external packaging of the drugs. Patients who use hospital-made drugs can then scan the QR code with WeChat and log in with their real names to the system to report possible adverse drug reactions and efficacy of the medical drugs used.

湖南三部门联合发文推进医疗机构制剂不良反应与疗效评价工作

来源:新浪财经  2022.03.10

近日,湖南省药监局与省卫健委、省中医药局联合发布《关于启用湖南省患者自主申报医疗机构制剂不良反应与疗效评价系统的通告》。《通知》要求,自2022年5月1日起,各医疗机构应通过“湖南省药品注册信息监管系统”下载制剂二维码,并印刷在制剂说明书、标签或内外包装的显著位置上。患者在使用医疗机构制剂过程中,通过手机微信扫描制剂二维码,实名登陆“湖南省患者自主申报医疗机构制剂不良反应与疗效评价系统”,报告所用制剂的不良反应与疗效。

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。