Schlagwort: ‘Drug Supply Chain’
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 establishes a Drug Quality and Security Traceability System for pharmaceutical enterprises
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
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
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
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。
New phase of development – the healthcare industry might be restructured
On 9th February, the State Council published an announcement stating several opinions about the further reform and improvement of the policy of drug manufacturing, distribution and utility. The announcement illustrates the top-down design in the reform directions of drug production, distribution and utility. The implementation of the announcement might restructure the layout of the industry. The healthcare industry might develop into a new phase. (Source: Dayoo.com)
发展进入新周期 医药行业或将重构格局
来源：大洋网 2017-02-15
核心提示：2月9日，国务院办公厅发布了《关于进一步改革完善药品生产流通使用政策的若干意见》，明确了我国药品生产、流通、使用三个领域改革方向的顶层设计。《意见》落地或将重构行业格局，医药行业发展进入新周期。
Pilot project in Beijing: delivery from manufacturer to patients
On 13th January at a conference of the Beijing People’s Congress, an officer from Beijing Health and Family Planning Commission said there will be a pilot project about the delivery of drugs in Beijing. Drugs will be delivered to patients by manufacturers directly without pharmacies, so that the space and labor in medical institutions can be saved. However, the prescriptions from doctors are still needed for the delivery. (Source: CN-healthcare)
北京将进行试点 药企对患者送药上门
来源：健康界 2017-01-18
核心提示：在1月13日的北京市十四届人大五次会议政务咨询会上，北京市卫计委相关负责人表示，对于社区百姓用药，北京将试点“送药上门”，也就是说，由药品厂家直接将药品送到患者手里，不经过药房，这样可以节约社区医疗机构的空间和人力，“当然还需要医生开具处方才可以”。
FDA and hospitals start to block medical representatives
After CCTV exposing that doctors accepted rake-off in Shanghai and Hunan, FDAs and hospitals in various regions started to take actions to block medical representatives. (Source: Saibailan)
各地卫计委和医院展开医药代表“封杀”行动
来源：赛柏蓝器械 2016-12-28
核心提示：在央视曝光上海、湖南两地医生收回扣事件之后，各地卫计委和医院正在展开针对医药代表的“封杀”行动。
Health authorities responded to the issue of doctors accepting rake-off
On 24th December, CCTV reported: “high drug price under the high rake-off”. After the report, CFDA immediately required the Health and Family Planning Administration Departments in Shanghai and Hunan to investigate the issue of high rake-off, publish the result in time and punish the people involved according to relative laws and regulations. Until 26th December, three doctors have been suspended. The involving drugs were stopped as well. Hunan FDA also suspended one involving doctor. (Source: Health News)
卫生主管部门回应医生收回扣事件
来源：健康报 2016-12-26
核心提示：12月24日，中央电视台新闻频道报道了《高回扣下的高药价》。报道发出后，国家卫生计生委立即要求上海、湖南两地卫生计生行政部门对报道中涉及的高价回扣事件展开调查，并及时向社会公布调查结果，对涉及的违规人员依法依规严肃处理。截至26日，上海市涉事的3名医生已停职接受调查，涉及药品已停止使用；湖南省卫生计生委已经对查明的一名涉事医生做出停职处理的决定。
A tracing system for the distribution of Chinese medicine went online in Hubei
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。