Kategorie: ‘Pharmaceutical Company News’
The revised “Pharmaceutical Administration Law” allows the online selling of prescription drugs
On August 26th, the revised “Pharmaceutical Administration Law” was approved by the Twelfth Session of the Thirteenth Standing Committee of the National People’s Congress and will come into effect on December 1st, 2019. The “Pharmaceutical Administration Law” proposed that the Marketing Authorisation Holders and pharmaceutical companies can sell drugs online on the premise of complying with relevant provisions. Vaccines, narcotic drugs, and other drugs under special control are not included.
新《药品管理法》对网售处方药开了绿灯
来源：医药网 2019.08.27
8月26日， 新修订版《药品管理法》经十三届全国人大常委会第十二次会议表决通过，并将自2019年12月1日起施行。法案提出，药品上市许可持有人、药品经营企业可在遵守法案关于药品经营的有关规定的前提下通过网络销售药品。疫苗、麻醉药品等国家实行特殊管理的药品不得在网络上销售。
Heilongjiang: The detailed rules of drug price supervision is going to be implemented
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。
“Drug Evaluation Report in 2018” is released
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。
“List of imported drugs that are suggested to be imitated” is released
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。
“Regulation provisions for imported medicinal materials” is released
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。
Medical insurance designated pharmacies will be incorporated in provincial centralized drug procurement
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。
The State issued two construction standards of the information-based traceability system of drugs
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。
Shanxi: Electronic first transaction information of drugs will be recognized
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。
The pilot program of national organized centralized procurement and use of drugs is officially released
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。
The first detailed document for “procurement of drugs(“4+7”)” is released
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。