Archive for August, 2018
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。
Medical insurance: Hospitals will be charged for insufficient medication
Recently, the Shanghai Municipal Bureau of Human Resources and Social Security, the Medical Insurance Office, the Health Planning Commission, the Food and Drug Administration, and the Price Bureau jointly issued “Notification on the Third Batch of medical insurance drug procurement with target quantity in Shanghai”. The “Notification” clarifies that all medical institutions across the city should give priority to purchasing and using the winning drugs of drug procurement with target quantity. Hospitals that are unable to complete normal purchase would be deducted from the medical insurance expenses. The “Notification” also stipulates that any form of “the Secondary negotiation“ is strictly prohibited.
医保：用药不足，医院将被扣费
来源：医药网 2018.08.27
核心提示：近日，上海市人社局、医保办、卫计委、食药监局、物价局五部门联合发布“关于做好本市第三批医保药品带量采购有关工作的通知（以下简称通知）”。通知明确，本市所有医疗机构应优先采购和使用带量采购中标药品，无法完成正常采购量的医院将被相应扣减医保费用额度。通知还要求，严禁任何形式的二次议价。
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。