Kategorie: ‘Pharmaceutical Company News’
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。
Opinions of the national basic medical system would be released
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。
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。
Anhui: The 2018 version of the medical insurance catalog is released
Recently, Anhui Human Resources and Social Security issued the “Medicine Catalogue of Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance in Anhui Province(2018 version)”, which will be implemented from July, 1st, 2018. The catalog includes 1481 western medicines and 1356 Chinese patent medicines. Anhui Human Resources and Social Security indicates that Anhui Province will use the unified “Drug Catalog” database. The drugs on the catalog will be coded according to the “Social Insurance Drug Classification Code”, which will be confirmed by the provincial medical insurance administrative department.
安徽：2018版医保目录出炉
来源：中国医药报 2018.05.29
核心提示：日前，安徽省人社厅发布《安徽省基本医疗保险、工伤保险和生育保险药品目录2018年版》，将于7月1日起执行。该目录包括西药1481个，中成药1356个。安徽省人社厅表示，安徽省将使用统一的《药品目录》数据库，并按照《社会保险药品分类代码》对目录药品进行对码，由省级医保行政部门进行确认。
National Health Commission was officially founded.
On 27th March, the Health Commission was officially founded, which is directed by Xiaowei Ma. The official name on the website has been changed from “National Health and Family Planning Commission” to “National Health Commission”. (Source: The Beijing News)
国家卫生健康委员会今日挂牌
来源：新京报 2018-03-27
核心提示：3月27日上午，卫健委正式挂牌，马晓伟出任主任、党组书记。目前官网名称已由原来的“中华人民共和国国家卫生和计划生育委员会”变更为“中华人民共和国国家卫生健康委员会”。
Pharmacist Sharing is coming!
On 7th March, Ali Health announced their new product “Pharmacist Sharing”, which offers the online “Pharmacist Sharing” consulting service to pharmacies for free. The shop assistant in offline pharmacies may consult the online licensed pharmacists to help customers at offline pharmacies in time. As known, the service team is built by Ali. There are around 3000 licensed pharmacists working every day from 8:30 to 24:00 for the online consulting. (Source: Zyzhan.com)
共享单车、共享充电宝……现在“共享药师”也来了！
来源：中国制药网 2018-03-08
核心提示：3月7日,阿里健康宣布推出“共享药师”产品, 免费面向社会药店店主提供第三方的开放平台的“共享药师”在线咨询服务。线下药店的店员可以咨询在线执业药师，从而帮助线下门店顾客及时解决用药咨询。据了解，该药师服务团队为阿里健康自建，约有3000名执业药师，每天从8：30到24：00服务在线咨询顾客。
Health insurance: payment on the basis of sickness categories
Recently, the Ministry of Human Resources and Social Security published the recommended sickness catalog for the payment of health insurance on the basis of sickness categories. 130 kinds of sicknesses are included in the catalog. As requested, at least 100 sicknesses should be confirmed for the new payment method from place to place. The Ministry of Human Resources and Social Security also emphasized that unreasonable medical payment increases should be controlled to make sure the personal expenditure will not increase. (Source: Beijing Youth Daily)
医疗保险按病种付费病种推荐目录
来源：北京青年报 2018-02-28
核心提示: 人社部近日公布了医疗保险按病种付费病种推荐目录，130种疾病被列入目录。按照要求，各地应确定不少于100个病种开展按病种付费。人社部强调，控制不合理医疗费用增长，确保群众个人费用负担不增加。
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”。