Categories
Pages
-

SmartMedCN

“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。

A unified national insurance standardized​ system will be established

November 8th, 2019 | by

On June 27th, the National Health Security Administration(NHSA) issued the “Guideline on the Standardisation of Medical Security.” The “Guideline” indicates that the exchange of medical security information in China has begun to use a common language——the “Coding Standard.” Now, the NHSA has completed four “Coding Standards”. Among them, the “Code and Classification of Medical Insurance Drugs” covers all drugs tapproved by the NMPA and realises “one-code-for-one-drug”, which makes it easier for the public to inquire about drug information and provides resource sharing. The “Guideline” also indicates that the NHSA will focus on the standardisation of medical insurance funds, medical price management, the medical security system and so on.

建立全国统一医保标准化体系

来源:医药网 2019.06.28

6月27日,国家医保局印发《医疗保障标准化工作指导意见》。《意见》指出,我国医疗保障信息交换已经开始使用通用语言——业务编码标准。目前,医保局已经完成了四项编码标准。其中,“医保药品分类与代码”覆盖了经药品监督管理部门批准上市的全部药品,实现了“一物一码”,可便于公众查询以及提供资源共享。《意见》还表明,国家医保局将在医保基金、医药价格管理、医疗保障系统等方面重点实行标准化。

“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。

Major Tasks of Medical Reform in 2019

November 8th, 2019 | by

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

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。

“List of National Intensive Monitoring Drug” is released

November 8th, 2019 | by

On July 1st, the Medical Administration Bureau of the National Health Commission issued the “Notification on printing the first List of National Intensive Monitoring Drug (Chemicals and Biological Products),” 20 drugs were selected in the “List.” The “Notification” stipulates that all provinces should form a list of provincial intensive monitoring drug on the basis of the national “List” and publish it for use by various medical institutions. All medical institutions should establish a regulatory system for monitoring drugs and strengthen the management of clinical applications of them. At the same time, the prescription management of drugs outside the “List” should also be strengthened.

重磅!国家重点监控药品目录公布

来源:医药网 2019.07.02

7月1日,国家卫健委医政医管局发布了《关于印发第一批国家重点监控合理用药药品目录(化药及生物制品)的通知》,共20个药品入选。 《通知》要求, 各省应在《目录》基础上形成省级重点监控合理用药药品目录并公布,以供各类医疗机构参考;各医疗机构要建立重点监控合理用药药品管理制度,加强目录内药品临床应用的全程管理;同时,还应加强目录外药品的处方管理。

Yinchuan implemented “prescription outflow”

October 10th, 2019 | by

Recently, the Yinchuan Prescription Audit and Transfer Platform connected six municipal hospitals to realize prescription outflow. 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

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。

Gansu: Online medical service for first-visit patients is not allowed

October 10th, 2019 | by

Recently, the Gansu provincial Health Commission published the “Administrative Measures for internet hospitals in Gansu province” to regulate internet hospitals and online medical services. The “Measures” stipulates that when patients visit internet hospitals, doctors can only provide follow-up service for the same diagnosis through the internet hospital after they have mastered the original case data of patients. The “Measures” clarifies that online medical services should be traceable throughout the whole course. Besides, internet hospitals can provide Contracted Family Doctor Service, and well-known experts are encouraged to set up online studios through Internet hospitals.

甘肃出台《办法》明确,不得对首诊患者开展互联网诊疗

来源:新浪医药新闻 2019.06.02

近日,甘肃省卫健委印发《甘肃省互联网医院管理办法》,进一步规范甘肃省互联网医院及互联网诊疗服务。《办法》规定,患者在互联网医院就诊时,医生只能在掌握患者病例资料后,通过互联网医院为相同诊断提供复诊服务。《办法》明确,互联网诊疗活动要做到全程可追溯;互联网医院可以提供家庭医生签约服务;鼓励知名专家通过互联网医院成立线上工作室。

Pharmacists are allowed to practice medicine at more than one pharmacies

October 10th, 2019 | by

On May 24th, Shanxi Food and Drug Administration issued the “Notification on strengthening the management of licensed pharmacists in pharmaceutical retail enterprises,” which encourages licensed pharmacists to practice medicine at more than one pharmacies during holidays and off-hours. The “Notification” indicates that licensed pharmacists in pharmacies can check prescriptions as telework to serve patients during their off-hours. To solve the shortage of licensed pharmacists in towns and villages, pharmacists in the township can assume the responsibility of licensed pharmacists.

药师可利用节假日和业余时间在零售药店多点执业

来源:制药网 2019.05.24

5月24日,陕西省药监局发布《关于加强药品零售企业执业药师管理的通知》,鼓励执业药师利用节假日和业余时间在药品零售企业多点执业,作为驻点执业药师不在岗的补充。《通知》指出,在执业药师非工作时间,药品零售门店可采用执业药师远程审方方式为患者服务;为解决乡、村药店执业药师短缺问题,乡镇药师可承担执业药师职责。

The State issued two construction standards of the information-based traceability system of drugs

October 8th, 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

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。

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。