Schlagwort: ‘Drug Saftey’
Tibet: supervising retail pharmacies
On April 20th, the Medical Product Administration of Tibet Autonomous Region issued the “Plan on Drug Supervision in Tibet Autonomous Region (2020).” The “Plan” indicates that drugs will be supervised in terms of their production, wholesale, trading, and usage. The “Plan” stipulates that the drug information management system, purchase channels, storage and transport state, auditing, and expiration date of drugs should be inspected, and at the same time, the sales of prescription drugs and services that provide by licensed pharmacists in retail pharmacies will be checked as well.
西藏开始监督检查零售药店
来源： 医药网 2020.04.22
4月20日， 西藏自治区药监局发布了“2020年西藏自治区药品监督检查计划”。“计划”明确，要在今年4月至11月对全区药品生产、批发、经营、使用单位进行检查。“计划”要求，应重点检查药品的计算机管理系统、进货渠道、储运条件、销售票帐货款一致性、有效期，同时检查药品零售企业的处方药销售和执业药师在岗服务。
Two regulations were deliberated and enacted
On March 30th, the State Administration for Market Regulation issued the “Measures for the Administration of Drug Registration” and “Measures for the Supervision of Pharmaceutical Productions,” which will come into effect on July 1st. The two “Measures” stipulate that drug registration and manufacturing should be strictly supervised to make sure the safety of drugs. Besides, the system of Marketing Authorization Holder (MAH) should be implemented comprehensively. Moreover, a drug safety assurance system should be established to manage the life cycle of drugs.
《药品注册管理办法》等两规章审议通过 7月1日起执行
来源：医药网 2020.03.31
3月30日，市场监管总局发布《药品注册管理办法》，《药品生产监督管理办法》，两部规章将于2020年7月1日起正式施行。两项《办法》要求，应严格管理药品注册和药品生产，保障药品质量安全；全面落实上市许可持有人管理制度；建立药品质量保证体系，对药品的全生命周期进行管理。
Ten drug traceability standards are implemented
Recently, the NMPA issued the “Basic Dataset of Drug Traceability for Marketing Authorization Holders and Manufacturers,” “Basic Dataset of Drug Traceability for Pharmaceutical Companies,” “Basic Dataset of Drug Traceability for Medical Organizations,” “Basic Technical Requirements for Drug Traceability Data Exchange,” and “Basic Dataset of Drug Traceability for Consumer Inquiry.” Up to now, ten drug traceability standards that were issued by the NMPA have been implemented.
10个药品追溯标准发布实施，实现来源可查，去向可追
来源：制药网 2020.03.12
近日，国家药监局印发《药品上市许可持有人和生产企业追溯基本数据集》，《药品经营企业追溯基本数据集》，《药品使用单位追溯基本数据集》，《药品追溯数据交换基本技术要求》,《药品追溯消费者查询基本数据集》。截止目前，国家药监局组织编制的10个药品追溯标准规范现已全部发布实施。
97 negotiations targeted drugs will be published on the internet (National Negotiation)
On December 16th, the NHSA and the National Health Commission jointly issued the “Notification on Ensuring the Usage and Supply of Drugs that are Targeted in the National Negotiation.” The “Notification” stipulated that provincial healthcare security administrations should publish the 97 negotiations targeted drugs on their centralized procurement platform and their new reimbursement drug lists. Besides, healthcare departments should regulate the usage and supply of these drugs and instruct medical institutions to reserve and use them properly according to functions, clinical requirements, and healing effects.
两部门发文：97个国家谈判药品按时直接挂网
来源：医药网 2019.12.18
12月16日，国家医保局、国家卫健委联合发布《关于做好2019年国家医保谈判药品落地工作的通知》。《通知》要求，各省级医保部门应在规定时限内将97个谈判药品在省级药品集中采购平台上直接挂网，并保证新版目录及时落地。此外，各地医保和卫生部门应对谈判药品的配备及使用等方面提出具体要求，并指导各定点医疗机构根据功能定位、临床需求、和诊疗能力等即时配备、合理使用。
A national drug use supervision platform is launched
The National Health Commission announced that a national drug use supervision platform is launched, which can provide data to support healthcare administrations to supervise and analyse the drug use. 8840 medical institutions have registered on the platform.
国家药品使用监测平台上线运行 8000多家医院已登陆
来源：医药网 2019.12.11
国家卫健委统计信息中心今日发布消息，国家药品使用监测平台正式上线运行。目前，已有8840家医疗卫生机构完成系统登录。卫健委表示，“国家药品使用监测平台”将为各级卫生健康药政管理部门开展药品配备使用情况监测分析提供数据支撑。
Online drug selling is being supervised
Recently, the National Development and Reform Commission and Ministry of Commerce jointly issued the “Negative List of Market access (2019 version),” which proposed that drug production and trading companies are not allowed to sell prescription drugs directly to the public through mail or internet trade.
网络售药行为进一步规范，邮寄处方药全面叫停
来源：制药网 2019.11.23
日前，国家发改委、商务部联合发布《市场准入负面清单（2019年版）》。其中明确提出：“药品生产、经营企业不得违反规定采用邮寄、互联网交易等方式直接向公众销售处方药。”
Supervising drug use in public hospitals in Inner Mongolia
On November 18th, the office of the Inner Mongolia Health Commission issued the “Notification on Implementing the Test and Analysis of Drug Use in Public Health Institutions.” The “Notification” stipulates that Inner Mongolia will select all the Tertiary, 50% of the Secondary, and 10% of the Primary medical insurance to analyse the drug use according to the stipulation of the National Health Commission. Therefore, the safety, effectiveness, and property rights of drug use will be comprehensively evaluated.
内蒙古卫健委发文：监测公立医院药品使用
来源：医药网 2019.11.21
11月18日，内蒙古自治区卫健委办公室发布《关于开展公立医疗卫生机构药品使用检测分析工作的通知》（以下简称《通知》）。《通知》提出，内蒙古将按照国家卫建委的相关要求，选取所有三级公立医疗卫生机构、50%二级公立医疗卫生机构以及10%基层公立医疗机构开展药品使用监测分析，由此对药品临床使用的安全性、有效性、经济性等开展综合评价。
“Guideline” for “Internet+Health Care” in Shandong province released
On July 11th, the Shandong Provincial Government issued the “Notification on the Construction Plan for Promoting a Demonstration Province of ‘Internet+Health Care’ from 2019 to 2020.” The “Notification” stipulates that to achieve the real-time exchange and sharing of medical data, the construction of a “traceability system of drugs,” a “pre-warning and detecting system of medicines in short supply,” and a “prescription circulation platform” should be promoted. The “Notification” indicates that the construction of “Internet Hospitals” based on medical institutes is encouraged, and the “consulting or prescribing medicine over the internet” should be widely implemented in Shandong province from 2020.
山东“互联网+医疗健康”的路线图， 来了！
来源：医药网 2019.07.15
核心提示：7月11日，山东省人民政府发布《关于印发山东省推进“互联网+医疗健康”示范省建设行动计划（2019-2020年）的通知》（以下简称《通知》）。《通知》指出，应加快药品追溯体系、短缺药品检测预警系统以及处方流转平台的建设，实现医疗数据的实时交换和共享。《通知》明确，鼓励建设依托医疗机构发展的互联网医院，2020年起应普遍开展互联网诊疗服务。
“List of National Intensive Monitoring Drug” is released
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。
“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。