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Archive for November, 2019

“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

核心提示: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 approved by the NMPA and realizes “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 standardization 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

核心提示: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. Although 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 to 2018.

《2018年度药品评审报告》发布

来源:中国医药报 2019.07.01

核心提示: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

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。

“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

核心提示: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。