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Schlagwort: ‘Drug Supply Chain’

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。

“Regulation provisions for imported medicinal materials” is released

October 8th, 2019 | by

Recently, the State Administration for Market Regulation issued the modified “Regulation Provision for imported medicinal materials,” which will be implemented on January 1, 2020. The “Provision” stipulates that more medicinal materials should be imported, and the imported medicinal materials should be classified and managed. The management of the imported medicinal material that is not done for the first time should be simplified according to the risk level, thereby reducing the time for examination and approval of imported medicinal materials. When purchasing imported drugs, the regulations of drug traceability should be strictly implemented.

《进口药材管理办法》发布,进口流程将简化

来源:制药网 2019.05.23

核心提示:日前,国家市场监督管理总局发布了修订后的《进口药材管理办法》(以下简称《办法》)并将于2020年1月1日起开始实施。《办法》要求,应鼓励更多药材进口,并对进口药材进行分类管理;根据风险级别简化非首次进口药材的进口管理,从而缩短进口药材的审批时间;在采购进口药品时,应严格执行药品追溯管理的有关规定。

A supplementary document for procurement of drugs is released(“4+7”)

October 8th, 2019 | by

On December 27th, the State Food and Drug Administration issued the “Notification on reinforcing drug supervision during the pilot of centralized procurement and use of selected drugs.” The “Notification” stipulated that each provincial drug regulatory authority should reinforce the quality supervision of the production, circulation, and use of selected drugs and the punishment for enterprises that violatie laws and regulations. The regulation authority should also urge the selected enterprises to establish a reporting system for inventory and off-production. The “Notification” indicates that the drug distribution should be regulated through related treaties to ensure the drug supply.

国家药监局发布4+7配套文件, 确保中标药品质量安全

来源:制药站 2018.12.28

核心提示:12月27日,国家药监局发布《国家药监局关于加强药品集中采购和使用试点期间药品监管工作的通知》(以下简称《通知》)。《通知》要求,各省级药品监管部门应加大对中标药品生产、流通、使用全周期的质量监管,加大违法违规企业的处罚力度,要督促中标生产企业建立企业库存和停产报告制度。《通知》指出,应通过协议规范配送行为,以保证药品供应。

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。

Opinions of the national basic medical system would be released

June 29th, 2019 | by

On September 19th, 2018, the State Council published “Guiding opinions on the improvement of the national basic medical system.” The “Guiding opinions” stipulates the establishment of a wholesome drug use monitoring platform and monitoring network system.It persists in centralized drug procurement, implements drug classification and acquisition; encourages local areas to combine basic drug system with classified medical treatment, family doctor contracting services and chronic disease health management so as to reduce the financial burden of patients. It establishes a wholesome national shortage of drug monitoring and early warning system, by the way of a reasonable purchase price, fixed-point production and unified distribution to ensure drug supply.

国家基本医药制度意见出台

来源:中国制药网 2018.09.19

核心提示:9月19日,国务院印发《关于完善国家基本医药制度的意见》。《意见》要求,建立健全的药品使用监测平台以及监测网络体系;坚持药品集中采购,落实药品分类采购;鼓励地方将基本药物制度与分级诊疗、家庭医生签约服务、慢性病健康管理结合,降低患者负担;建立健全的全国短缺药品监测预警系统,确定合理采购价格、定点生产、统一配送以保证药品供应。

Anhui establishes a Drug Quality and Security Traceability System for pharmaceutical enterprises

June 29th, 2019 | by

Recently, the Anhui Food and Drug Administration issued the “Guiding Opinions on the Construction of Drug Quality and Safety Traceability System for Pharmaceutical Enterprises in Anhui Province.” The “Guiding Opinions” clarify that pharmaceutical enterprises all over the province should establish a drug traceability system in accordance with laws and regulations. The traced information content of all links of the drug business should be true, accurate and complete, and should be saved at least for five years. For those who have not yet established a traceability system and for those traceability systems who do not operate effectively, especially when included incorrect information or incomplete information, it will be seriously investigated and dealt with following relevant laws and regulations.

安徽部署建立药品经营企业质量安全追溯体系

来源:中国医药报 2018.08.03

核心提示:日前,安徽省食品药品监管局印发《安徽省药品经营企业药品质量安全追溯体系建设指导意见》(以下简称《意见》)。《意见》明确,全省药品经营企业应按照法律法规建立药品追溯制度,药品经营各环节追溯信息内容应真实、准确、完整,且至少保存五年。对于没有建立追溯体系、追溯体系不能有效运行,特别是出现不真实信息或信息丢失的,将依照相关法律法规严肃查处。

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。

10 pharmacies became pilot stations for recycling expired drugs

March 21st, 2018 | by

To safeguard the pharmaceutical market order, one should avoid that expired drugs flow into the market and endanger the medication safety. The Committee on Capital Markets Regulation Tianjin organized that the pharmaceutical drug retailers start the recycling of expired drugs. On 29th November 2017, the long-term basis recycling work of expired drugs officially started. For the first batch, 10 pharmacies became pilot stations. (Source: China Network Finance)

天津10家药店试点过期药回收

来源:中国网财经 2017-11-30

核心提示: 为保障药品市场秩序,防止过期药品流入市场,保证百姓用药安全,天津市市场监管委组织天津市药品零售企业积极开展过期药品回收工作。2017年11月29日,天津市过期药品长期回收活动正式启动,首批10个药店纳入试点。

The supervision and management regulation for drug retailing online seeks for opinions: Prescription drugs are forbidden to sell online

March 21st, 2018 | by

CFDA recently publishes the supervision and management regulation for drug retailing online (exposure draft) and asks for opinions from the public. The exposure draft emphasizes that pharmacies online should neither sell prescription drugs, nor exhibit information of them. Licensed pharmacists are also necessary for pharmacies online. These are also the latest management regulation for pharmacies online, which will further enhance the distribution environment of drug retailing online and maintain the medication safety. (Source: Souhu)

网络药品经营监督管理办法征求意见:处方药禁止网售

来源:搜狐 2017-11-17

核心提示:国家食品药品监督管理总局组织起草了《网络药品经营监督管理办法(征求意见稿)》,并向社会公开征求意见。征求意见稿强调了网上药店不能违规销售处方药、不得展示处方药信息、须配备执业医师等相关要求。这也是最新针对网上药店的管理办法,将进一步强化网络药品经营流通环境、维护用药安全。