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Kategorie: ‘Pharmaceutical Company News’

“List of imported drugs that are suggested to be imitated” is released

November 8th, 2019 | by

On June 20th, the National Health Commission issued the initial “List of imported drugs that are suggested to be imitated.” The National Health Commission has cooperated with the National Medical Products Administration and other departments to organise experts to select a total of 34 drugs whose patents expire or patents that are about to expire but have not been filed for registration. The “List” also includes drugs that are in short supply or actively declared by enterprises.

首批鼓励仿制药品目录 34个药品入选

来源:医药网 2019.06.21

6月20日,国家卫健委公布《第一批鼓励仿制药品目录建议清单》。国家卫健委联合国家药监局等部门,组织专家从国内专利到期和专利即将到期却尚未提出注册申请、临床供应短缺以及企业主动申报的药品进行遴选,提出共计34个品种。

“Drug Evaluation Report in 2018” is released

November 8th, 2019 | by

On July 1st, the National Medical Products Administration(NMPA) issued the “Drug Evaluation Report in 2018.” The “Report” shows that the Drug Evaluation Centre of the NMPA reviewed and approved 106 new drugs in 2018. CAlthough the number of applications for registration of new drugs has increased by 47%, the evaluation time has been reduced significantly in comparison to 2017. Benefiting from the accelerated drug evaluation reforms, the number of applications for registration of innovative drugs has increased significantly in 2018, of which 85% were from domestic companies. At the same time, in order to improve the quality of generic drugs, the Drug Evaluation Centre has made every effort to promote the “Quality Consistency Evaluation for Generic Drugs,” and there were eight batches of generic drugs that are involved in comparison in to 2018.

《2018年度药品评审报告》发布

来源:中国医药报 2019.07.01

7月1日,国家药品监管局发布《2018年度药品评审报告》(以下简称《报告》)。《报告》显示,2018年国家药监局药品评审中心共审评通过106个新药;新药注册申请较2017年增长了47%,但注册申请审评用时明显下降;受益于药审改革加速,2018年创新药注册申请数量大幅增长,其中85%的注册申请来自国内企业;同时,为提升我国仿制药质量,药品审评中心全力推进仿制药治疗和疗效一致性评价工作,2018年全年正式发布了8批参比制剂目录。

Medical insurance designated pharmacies will be incorporated in provincial centralized drug procurement

October 8th, 2019 | by

On May 15th, the Shandong provincial drug purchasing website released a document of “Opinions on the trial implementation of centralized online drug procurement by private pharmaceutical institutions.” The “Opinion” stipulates that private hospitals and chain pharmacies which are managed by the Medical Insurance Protocol should purchase drugs online through the centralized procurement platform of Shandong province, with the total purchase amount not less than 60% of the original usage. The “Opinion” will be implemented on July 1st.

重磅!医保定点药店纳入省级药品集采

来源:新浪医药新闻  2019.05.17

5月15日,山东省药品采购网发布文件《关于民营医药机构试行网上药品集中采购的意见》(以下简称《意见》)。《意见》要求,医疗保险协议管理的民营医院、连锁零售药店,应通过山东省药品集中采购平台网上采购药品,采购总量不低于原使用量的60%。据悉,《意见》将于7月1日开始执行。

“Regulation provisions for imported medicinal materials” is released

October 8th, 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

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。

Shanxi: Electronic first transaction information of drugs will be recognized

October 8th, 2019 | by

On April 26th, Shanxi Food and Drug Administersration issued the “Implementation Opinion of promoting the transformation and upgrading of pharmaceutical enterprises (consultation paper).” The “Implementation Opinion” clarified that pharmaceutical enterprises are encouraged to implement electronic management of the first transaction information of drugs under the premise of the quality, safety, and traceability. The Drug and Food Administration recognizesd the electronic first transaction information during the certification and inspection that obey the “Good Supply Practice for Pharmaceutical Products.”

山西药监局明确检查时认可电子首营

来源:新浪医药新闻  2019.04.29

4月26日,山西省药品监督管理局发布《关于推动药品流通企业转型升级创意发展的实施意见(征求意见稿)》(下文简称《意见稿》)。《意见稿》明确,鼓励药品经营企业开展药品经营业务时,在确保药品质量安全、可追溯的前提下实行首营品种档案电子化管理。药品监管部门在实施《药品经营质量管理规范》认证检查时对电子首营资料予以认可。

The first detailed document for “procurement of drugs(“4+7”)” is released

October 8th, 2019 | by

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

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。

Guangdong: Pharmacists are permitted not only to provide medical advice but also charge for prescription

July 22nd, 2019 | by

Recently, Guangdong Pharmaceutical Association issued “Tentative Standard of Pharmaceutical Outpatient Service”. The “Tentative Standard” proposes that pharmacists can serve patients directly through outpatient service. The “Tentative Standard” stipulates that a fixed consulting room should be set up in the outpatient building and a fixed pharmacist’s treatment time should be set every week. Medical institutions should be equipped with pharmacist workstation if possible in order to maintain patient records. Meanwhile, the “Tentative Standard” shows that it is recommended to grant partial prescription authority to pharmacy outpatient pharmacists, which must be approved and filed by the medical department.

广东:药师不仅可坐诊,还可开具处方收费了

来源:医药网 2018.11.20

日前,广东省药学会发布《药学门诊试行标准》(以下简称《标准》)。《标准》提出,药师可通过门诊直接面对患者提供服务。《标准》规定,应在门诊楼设置固定诊室,并且每周设有固定的药师出诊时间;有条件的医疗机构应配备药师工作站,为患者建档管理。同时,《标准》中显示,建议授予药学门诊药师部分处方权限,并经医务部门批准和备案。

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。

The electronic drug regulation will be recommissioned

July 11th, 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。

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。