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Schlagwort: ‘Drug Supply Chain’

Online drug selling is being supervised

April 3rd, 2020 | by

Recently, the National Development and Reform Commission and Ministry of Commerce jointly issued the “Negative List of Market access (2019 version),” which proposed that drug production and trading companies are not allowed to sell prescription drugs directly to the public through mail or internet trade.

网络售药行为进一步规范,邮寄处方药全面叫停

来源:制药网 2019.11.23

日前,国家发改委、商务部联合发布《市场准入负面清单(2019年版)》。其中明确提出:“药品生产、经营企业不得违反规定采用邮寄、互联网交易等方式直接向公众销售处方药。”

Improving the supply system of shortage medicines

April 3rd, 2020 | by

Recently, the General Office of the State Council issued the “Guiding Opinions on Maintaining the Price and Supply of Shortage Medicines.” The “Guiding Opinion” stipulated that a national multi-source information collection platform for shortage medicines and a monitoring system for this platform should be established to realise information sharing of APIs (Active Pharmaceutical Ingredient) and pharmaceutical preparations in terms of their registration, production, procurement, and price. As for the drugs in the shortages list, pharmaceutical enterprises are allowed to quote their price on the provincial-level centralised drug procurement platform or on the internet so that medical institutions can purchase them on demand.

国办:强化药品价格常态化监管 完善短缺药品供应体系

来源:医药网 2019.10.14

近日,国务院办公厅印发《关于进一步做好短缺药品保供稳价工作的意见》(以下简称《意见》)。《意见》指出,应建立国家短缺药品多源信息采集平台和协同监测机制,实现原料药和制剂在注册、生产、采购、价格等方面的信息联通共享;对于短缺药品清单中的品种,允许企业在省级药品集中采购平台上自主报价、直接挂网,医疗机构自主采购。

Heilongjiang: The detailed rules of drug price supervision is going to be implemented

February 13th, 2020 | by

On August 9th, the Medical Insurance Bureau of the Heilongjiang province issued the “Notification of Supervising Drug Price and Distribution Information.” The “Notification” stipulates that the supervision of drug price and distribution information should be carried from drug manufacturers, distribution enterprises, medical institutions, retail pharmacies, and public sentiment. The mechanisms for information collection, reporting, analysis, investigation, and processing should be improved at the provincial, city, and county levels.

药品价格监测地方细则来了!月月报送、五方联动……

来源:医药网 2019.08.12

8月9日,黑龙江省医保局发布了《关于做好药品价格和配送信息检测工作的通知》(以下简称《通知》)。《通知》指出,应从药品生产企业、配送企业、医疗机构、定点零售药店和社会舆情五个方面开展药品价格和配送信息检测;健全并完善省、市、县三级联动的信息采集、报送、分析、调查、处理机制。

“Guideline” for “Internet+Health Care” in Shandong province released

February 13th, 2020 | by

On July 11th, the Shandong Provincial Government issued the “Notification on the Construction Plan for Promoting a Demonstration Province of ‘Internet+Health Care’ from 2019 to 2020.” The “Notification” stipulates that to achieve the real-time exchange and sharing of medical data, the construction of a “traceability system of drugs,” a “pre-warning and detecting system of medicines in short supply,” and a “prescription circulation platform” should be promoted. The “Notification” indicates that the construction of “Internet Hospitals” based on medical institutes is encouraged, and the “consulting or prescribing medicine over the internet” should be widely implemented in Shandong province from 2020.

山东“互联网+医疗健康”的路线图, 来了!

来源:医药网 2019.07.15

核心提示:7月11日,山东省人民政府发布《关于印发山东省推进“互联网+医疗健康”示范省建设行动计划(2019-2020年)的通知》(以下简称《通知》)。《通知》指出,应加快药品追溯体系、短缺药品检测预警系统以及处方流转平台的建设,实现医疗数据的实时交换和共享。《通知》明确,鼓励建设依托医疗机构发展的互联网医院,2020年起应普遍开展互联网诊疗服务。

“Regulation provisions for imported medicinal materials” is released

October 9th, 2019 | by

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

October 9th, 2019 | by

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。

A supplementary document for procurement of drugs is released(“4+7”)

July 18th, 2019 | by

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

July 11th, 2019 | by

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

June 29th, 2019 | by

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

June 29th, 2019 | by

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。