Schlagwort: ‘Drug Saftey’
A supplementary document for procurement of drugs is released(“4+7”)
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
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
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。
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。
