Schlagwort: ‘Drug Saftey’
Major Tasks of Medical Reform in 2019
On June 4th, the General Office of the States Council officially issued the “Notification of Major Tasks of deepening the reform of the medical and health system in 2019.” The “Notification” clarifies that the National Health Commission should issue a list of drugs that are suggested to be imitated. The State Medical Insurance Bureau and other departments should promote the national organized centralized procurement and use of drugs, and strengthen the supervision of the quality of selected drugs, the priority use of selected drugs in public medical institutions of pilot areas, the payment settlement, and the production of both selected drugs and raw materials. Besides, these departments should also accelerate the reform of medical insurance payment methods and carry out the pilot program of DRGS payment.
2019医改重点任务：推进药品集中采购试点
来源：医药网 2019.06.05
核心提示：6月4日，国务院办公厅正式发布《深化医药卫生体制改革2019年重点工作任务的通知》。《通知》明确，国家卫生健康委应发布鼓励仿治药品目录; 国家医保局等部门推进国家组织药品集中采购和使用试点，加强对中标药品质量、试点地区公立医疗机构优先使用和药款结算、中标药品及原料药生产的检测等工作。另外，应加快推进医保支付方式改革，开展按疾病诊断相关分组付费试点。
Yinchuan implemented “prescription sharing”
Recently, the Yinchuan Prescription Sharing Platform connected six municipal hospitals to realize prescription sharing. The platform unifies the prescriptions of all hospitals, communities, and internet hospitals throughout the city to ensure drug safety. At the same time, patients can choose pharmacies and purchase methods according to various selection modes such as the lowest price, nearest distance, self-service to get medicines, or third-party delivery. Mr. Ma Xiaofei, director of the Yinchuan Health Committee, stated that because the platform has reduced the number of prescriptions that licensed pharmacists should review, it will relieve the pressure of the shortage of licensed pharmacists and solve the problem of licensed pharmacist renting their licenses to others.
银川市处方全部外流，解决执业药师挂证问题
来源：医药网 2019.06.03
核心提示：近日，银川市处方审核流转平台接入6家市属医院，医院处方全部外流。该处方审核流转平台将全市所有医院、社区和互联网医院的处方统一审核，保障用药安全。同时，患者可按照价格最低、距离最近、自助取药或第三方配送等多种选择模式，自主选择药店和购买方式。银川市卫健委主任马晓飞表示，由于该平台减少了执业药师的审方数量，会一定程度上缓解药师人数不足的压力并解决执业药师挂证问题。
“Regulation provisions for imported medicinal materials” is released
Recently, the State Administration for Market Regulation issued the modified “Regulation Provision for imported medicinal materials,” which will be implemented on January 1, 2020. The “Provision” stipulates that more medicinal materials should be imported, and the imported medicinal materials should be classified and managed. The management of the imported medicinal material that is not done for the first time should be simplified according to the risk level, thereby reducing the time for examination and approval of imported medicinal materials. When purchasing imported drugs, the regulations of drug traceability should be strictly implemented.
《进口药材管理办法》发布，进口流程将简化
来源：制药网 2019.05.23
核心提示：日前，国家市场监督管理总局发布了修订后的《进口药材管理办法》（以下简称《办法》）并将于2020年1月1日起开始实施。《办法》要求，应鼓励更多药材进口，并对进口药材进行分类管理；根据风险级别简化非首次进口药材的进口管理，从而缩短进口药材的审批时间；在采购进口药品时，应严格执行药品追溯管理的有关规定。
The State issued two construction standards of the information-based traceability system of drugs
Recently, the National Medical Products Administration issued the “Guideline on the construction of an information-based traceability system of drugs” and the „Requests for the coding of the drug traceability code,” which will be implemented since the release date. The “Guideline” indicates that the information-based traceability system should contain a drug traceability system, a collaborative service platform, and a regulatory system. Besides, it should also include the traceability information in the whole process of drug production, circulation, and use, and it fulfils the function of collecting, storing, and sharing the traceability information. The system can be divided into two categories: self-built traceability system of enterprises and traceability system provided by third-party institutions.
两项药品信息化追溯体系建设标准出炉，保证药品信息安全
来源：制药网 2019.05.06
核心提示：日前，国家药监局发布了《药品信息化追溯体系建设导则》（以下简称《导则》）和《药品追溯码编码要求》两项信息化标准，并于发布日起实施。《导则》指出，药品信息化追溯体系应包含药品追溯系统、药品追溯协同服务平台和药品追溯监管系统。同时，还应包含药品在生产、流通及使用等全过程追溯信息，并具有对追溯信息的采集、存储和共享功能，可分为企业自建追溯系统和第三方机构提供的追溯系统两大类。
The first detailed document for “procurement of drugs(“4+7”)” is released
Recently, Dalian city issued the “Implementation of a National Organised Work plan for centralized Procurement and Use of drugs (consultation paper).” The “Paper” stipulated that public medical institutions should sign a contract with the pharmaceutical production enterprises for the procurement of drugs with defined purchasing quantities and settle the payment of drugs promptly. Medical institutions should run out the contract amount within one year under the premise of ensuring the priority use of the selected drugs. The staff in medical institutions which do not use the drugs as required will be treated seriously by the relevant provisions. The Paper also clarified that the quality and use of selected drugs should be intensively monitored.
“4+7”带量采购，头一份细则文件来了！
来源：制药网 2019.01.11
核心提示：日前，大连市发布《贯彻落实国家组织药品集中采购和使用工作方案（征求意见稿）》。意见稿要求，公立医疗机构与药品生产企业应签订带量采购合同并及时结算药款，在确保中选药品优先使用的前提下，一年内完成合同用量；不按规定使用药品的医务人员，按照相应条款严肃处理。意见稿明确，应重点监测中选药品的质量和使用情况。
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”。