Schlagwort: ‘Drug Saftey’
New method for supervision and management of drug online sale – supervision for online sale should be in accordance with offline sales
On 9th February, the CFDA published the supervision and management method of drug online sale and asked for opinions. The method shows that drug online sales have developed very quickly. However, the supervision laws and regulations are relatively legging behind, so that there are new problems in the supervision link. The CFDA published this method to improve the supervision and ask for opinions. It is required in the method that drug online sales should be in accordance with offline sales; responsibilities should be clarified; based on internet technology of the third-party platform, using internet to supervise internet; “ordering online and delivered offline” is encouraged. (Source: VCBEAT)
总局发布药品网络销售监督管理办法 明确线上线下一致监管原则
来源：动脉网 2018-02-11
核心提示：2月9日，食品药品监管总局发布《药品网络销售监督管理办法（征求意见稿）》。《办法》指出，网售药品发展迅猛，但监管法规相对滞后，造成监管环节的一些新问题。为完善监管，食药监总局起草该文件，并希望社会广泛参与讨论。《办法》要求，网售药品应坚持线上线下一致的原则；厘清责任、社会共治；同时依托第三方平台的网络技术、客户粘性等优势，“以网管网”；鼓励“网订店取、网订店送”。
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。
New policies for vaccine come again
On 7th February, the State Council announced to further strengthen the management work of vaccine distribution and vaccination. 6 aspects are carried out to keep the focus on vaccine quality and security of vaccination: 1. improving the management mechanism of vaccine; 2. accelerating the self-research of vaccine and the improvement of the quality; 3. strengthening the whole-process management of the vaccine distribution; 4. regulating the vaccination management; 5. Carrying out the safeguard measures; 6. Strengthening the supervision and inspection. (Source: Menet)
疫苗新政再度来袭
来源：米内网 2017-02-09
核心提示：2月7日，国务院办公厅发布了《关于进一步加强疫苗流通和预防接种管理工作的意见》，六大方面的内容紧紧围绕着疫苗质量和接种安全展开：一、完善疫苗管理工作机制;二、促进疫苗自主研发和质量提升;三、加强疫苗流通全过程管理;四、规范预防接种管理;五、落实保障措施;六、强化监督检查。
The 13th Five-Year Plan for the industry of pharmaceutical distribution came out
Recently, the Ministry of Commerce published the industrial development plan of pharmaceutical distribution (2016-2020). The plan cleared the overall goals for the industry of pharmaceutical distribution during the 13th Five-Year. There are five key tasks in the plan: 1. reasonable planning of the industrial layout and integrating the drug distribution network; 2. improving the level of distribution management and training modern pharmaceutical suppliers; 3. innovating the industrial business model, and expanding the service function of the industry; 4. combining import and export, improving the openness of the industry; 5. strengthening the infrastructure of the industry, and improving the ability of industrial service. (Source: Shanghai Securities News)
药品流通业十三五规划出炉 药品零售企业将迎来利好
来源：上海证券报 2016-12-30
核心提示：近日，商务部印发《全国药品流通行业发展规划(2016-2020年)。《规划》明确了“十三五”期间药品流通行业的总体目标，并特别提出五项重点任务：一是合理规划行业布局，健全药品流通网络。二是提升流通管理水平，打造现代医药供应商。三是创新行业经营模式，拓展行业服务功能。四是“引进来”与“走出去”相结合，提升行业开放水平。五是加强行业基础建设，提高行业服务能力。
CFDA ferrets out Illegal ingredients – five pharmaceutical manufacturers stop the production
In the evening of 7th December, CFDA published the No.159 casual inspection announcement in 2016. In the national drug casual inspection, drugs in six batches from five manufacturers were ferreted out to contain abietic acid or Scarlet 808. The Food and Drug Administrations of Jilin, Qinghai and Tibet Autonomous Region have already taken the product control actions to seal up, distrain, stop selling and recall the ferreted drugs. Withal CFDA asked FDAs of Jilin, Qinghai and Tibet Autonomous Region to immediately instruct the manufacturers to stop related productions and investigate the reasons thoroughly. The production should not be recovered until the reasons are clear and the rectifications are done. (Source: Chinamsr)
CFDA查出非法添加物，5药企停产！
来源：中国医药联盟 2016-12-08
核心提示：12月7日晚间，国家食药总局发布2016年第159号抽检通告。在国家药品抽验中，标示为吉林永利药业股份有限公司等5家企业生产的6批次药品检出松香酸或808猩红。对上述药品，吉林省、青海省、西藏自治区食品药品监督管理局已采取了查封扣押、暂停销售使用、要求企业主动召回等产品控制措施。对此，国家食品药品监督管理总局要求吉林省、青海省、西藏自治区食品药品监督管理局立即责令上述企业暂停相关产品生产，彻查药品质量问题原因，查清原因并整改到位前不得恢复生产。
The strictest rule against transfusion at outpatient service
Recently, Tianjin Health and Family Planning Commission published an announcement about regulating the management work of antibacterial agent transfusion. All medical institutions should carry out investigations about the current situation of antibacterial agent transfusion. After analyses, assessments, studies and judges, relevant measures should be planned to implement the “ten key information of rational drug use”, which was formulated by National Health and Family Planning Commission. Until the end of 2016, all antibacterial agent transfusion should stop at outpatient services (except pediatrics). For pediatrics, relevant diagnosis and treatment rules must be followed strictly. The indications of antibacterial agent transfusion must be accurately seized, to avoid any irrational drug use. (Source: Chinamsr)
最严门诊禁输液来了！
来源：中国医药联盟 2016-11-16
核心提示：近日，天津市卫计委发布《关于规范门诊静脉输注抗菌药物管理工作的通知》，要求各级各类医疗机构要对门诊输注抗菌药物的情况进行摸底调查，认真分析、评估，对有关就诊形势开展研判，制定相关措施，落实国家卫生计生委等部门制定的“合理用药十大核心信息”。到2016年底，全部停止在门诊输注抗菌药物（儿科除外）。对于儿科要严格对照相关诊疗规范，准确把握静脉输注抗菌药物的指征，杜绝药物不合理应用。
Unified management of physicians according to codes in Fujian
On 11th November, Fujian Medical Security Management Committee published an announcement about the unified management of physicians according to codes. At the moment the codes of local physicians are being collected by medical security agencies in Fujian. After a review, the codes will be recorded in the physician database for the whole province of Fujian. This work is planned to be done by 31th December. After all codes will be recorded in the database, every unreasonable medical expense can be traced to the physician, so that the overall process management of medical treatments of doctors becomes possible. (Source: the 21th Century Economic Report)
福建医师代码统一管理 不合理医药费用责任追踪到个人
来源：21世纪经济报道 2016-11-15
核心提示：福建省医疗保障管理委员会办公室于本月11日正式发布《关于做好全省统一医保医师代码管理的通知》。现阶段福建省内各设区市医保经办机构正采集、汇总和审核本地区医保医师代码，审核通过的代码将录入全省医保医师代码库。相关工作将于12月31日前后结束。所有代码入库后，将全面实现每一笔不合理医药费用追踪到个人，进而实现对医生医疗行为的“事前、事中、事后”全过程管理。
Pilot “electronic prescriptions” in retail pharmacies in Chengdu
To solve the problems of the sale and supervision of prescription drugs, and to meet the demand of purchasing drugs, the pilot project of “electronic prescriptions” is being carried out in Chengdu. Until now, around 3000 pharmacies in Chengdu offer the consultation service, and 1800 pharmacies carry out the pilot project of electronic prescriptions, where people can get consultations, electronic prescriptions and review electronic prescriptions for free. (Source: Economic Information Daily)
成都在零售药店试点“电子处方”
来源：经济参考报 2016-11-11
核心提示：为破解处方药销售和监管难题，同时满足老百姓的购药需求，成都市正全面开展零售连锁药店“电子处方”试点。目前，该市已开通咨询服务的药店有3000余家，开通电子处方试点的有1800余家，这些药店可免费为老百姓提供咨询、电子处方开具、审核等服务。
Six ministries published the development planning guide for the pharmaceutical industry
Six ministries, including Ministry of Industry and Information Technology, recently published the development planning guide for the pharmaceutical industry. The guide sets up targets from eight aspects for the pharmaceutical industry during the time of the 13th Five-Year Plan and helps the pharmaceutical industry to develop better. The eight aspects are: 1. Industry scale; 2. Technology innovation; 3. Production quality; 4. Green development; 5. Smart manufacturing; 6. Supply support; 7. Organization structure; 8. Internationalization. (Source: Medicine Economic News)
6部门联合发布医药工业发展规划指南
来源：医药经济报 2016-11-08
核心提示：工信部等6部门日前联合发布《医药工业发展规划指南》，从8个方面为“十三五”期间医药工业的发展设定目标，助力医药工业更好的发展。8个方面为：1行业规模；2技术创新；3产品质量；4绿色发展；5智能制造；6供应保障；7组织结构；8国际化。
The outpatient clinic of medication consultation is under planning in Beijing
Beijing Municipal Administration of Hospitals held the finals of the 2016 competition of pharmacists’ counselling skills. The deputy director of Beijing Municipal Administration said that they were actively planning to set up the outpatient clinic of medication consultation in municipal hospitals. The public Wechat account of “Beijing Pharmacists” will come out soon, to offer more individualized, continuously traceable consultation services with evident featured specialties. (Source: Health News)
北京拟推用药咨询门诊
来源：健康报 2016-10-19
核心提示：北京市医院管理局日前举办2016年药师咨询技能大赛决赛。北京市医院管理局副局长边宝生表示，目前，该局正积极研究在市属医院开设用药咨询门诊，并将于近期推出“京城药师”微信公众号，向患者提供更为个体化的、持续可追踪的、专科特色明显的咨询服务。