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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

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。

“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。

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

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。

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

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。

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

核心提示: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。

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

October 8th, 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。

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

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。

The pilot program of national organized centralized procurement and use of drugs is officially released

October 8th, 2019 | by

On January 17th, the General Office of the State Council officially issued the “Notification of National Organized Pivot Program for the Centralized Procurement and Use of Drugs.” The “Notification” clarified that the purchase way for each selected drug depends on the number of its production enterprises. The “Notification” stipulated that the advance payment should not be less than 30% of the purchase amount and the total purchase quantity should account for 60%-70% of the full annual drug use of public medical institutions. The centralized procurement this time will be implemented in early 2019 with one year.

国家药品集中采购和使用试点方案正式发布

来源:制药网 2019.01.18

核心提示:1月17日,国务院办公厅正式发布《国家组织药品集中采购和使用试点方案的通知》。《通知》明确,应根据每种药品入围的生产企业数量分别采取相应的集中采购方式。《通知》要求,预付金额不得低于采购金额的30%;采购总量应占公立医疗机构年度药品总用量的60%-70%。本次集中采购将于2019年初开始实施,周期为一年。

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。