Kategorie: ‘Other Hot Topics’
New stipulations on medication managment in pharmacies
On July 1st, the National Medical Products Administration issued the “Stipulations on Management of Drug Data and Records of Drugs.” The “Stipulation” clarifies that one or more types of records methods should be adopted according to the needs of activities, which include developing, producing, trading, and using drugs, and the records process should be veritable, accurate, intact, and traceable. The records can be expressed in papery, electronic or mixed forms, and the recorded data should be managed according to stipulations.
药店药品管理又有新要求了
来源：新浪医药新闻 2020.07.02
7月1日，国家药监局发布了《药品记录与数据管理要求（试行）》（以下简称《要求》），自2020年12月1日起施行。《要求》明确，从事药品研制、生产、经营、使用活动，应当根据活动的需求，采用一种或多种记录类型，保证全过程真实、准确、完整和可追溯。记录载体可采用纸质、电子或混合等形式，并应根据要求对所记录数据进行管理。
Improving the supervision on unreasonable or illegal behaviors of drug online trading
On April 24th, the NMPA held the video conference for renovating the unreasonable or illegal behaviors of drug online trading and administrating the circulation of medicines. The conference indicates that the drug online trading services should be further regulated to realize constant supervision over the entire trading process and ensure the medication safety; use the National Monitoring System to track and detect the unreasonable or illegal behaviors of drug online trading dynamically.
药品网络销售违法违规行为专项整治深入推进
来源： 医药网 2020.04.26
4月24日，国家药品监督管理局药品监管司主持召开药品网络销售违法违规行为专项整治及药品流通监管工作调度视频会。会议强调，应进一步规范药品网络销售和药品网络交易服务，实现全过程、全周期监管，强化公众用药安全保障；利用国家药品网络交易监测系统对网络药品经营违法违规行为进行动态跟踪检测。
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。
Deepening the reform of the medical and health care system
On February 25th, the State Council issued the “Opinions on Deepening the Reform of the Medical and Health Care System.” The “Opinion” stipulates that medical institutions should improve the management of drug reimbursement lists, medical service protocols, and medicare settlement or increase the efficiency of medicare payment. Besides, the use of medical insurance funds should be strictly supervised, and insurance fraud will be dealt with according to legislation. In addition, the reform of centralized drug procurement should be deepened, and a pricing system that depends on the market should be established. Moreover, medical institutions should improve their service capacity and standardize new medical services, such as consulting over the internet.
关于深化医疗保障制度改革的意见
来源：医药网 2020.03.06
2月25日，国务院发布《关于深化医疗保障制度改革的意见》。《意见》要求，应完善医保目录、协议、结算管理，提升医保支付效率；完善医保基金监管，依法追究欺诈骗保行为；深化药品集中带量采购制度改革，并建立以市场为主导的药品价格形成机制；增强医疗服务能力，规范“互联网+医疗”等新服务模式发展。
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。
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。”
Nationwide implementation of National Organised Centralised Procurement and Use of Drugs
On September 24th, 2019, more than 20 provinces and districts all over the country have launched a joint procurement of drugs. Thereby the pilot work on National Organised Centralised Procurement and Use of Drugs is extended from 11 big cities to nationwide. The price of all medicines was lower than the price of selected drugs in “4+7.”
医保局：国家组织药品集中采购和使用试点扩至全国
来源：医药网 2019.09.25
9月24日，全国二十多个省、区启动药品联合招标采购，国家组织药品集中采购和使用试点由11个城市扩大至全国。在此次扩围采购中，药品价格都降低到不高于此前11个试点城市中选价格的水平。
Internet Hospital established by Yifeng Pharmacy
On September 19th, Yifeng Pharmacy announced a joint venture with Visum Pharmaceutical Co., Ltd. to establish Hainan Yifeng Medical Technology Co., Ltd., which aims to provide patients with services such as Internet Hospitals, Prescription Sharing Platform, family doctors, health management, online medical consultations, and patient education.
他来了！这家连锁药店巨头开建互联网医院
来源：新浪医药新闻 2019.09.22
9月19日，益丰大药房宣布与海南华益合资设立海南益丰医疗科技有限公司，旨在为用户提供互联网医院、处方流转平台、家庭私人医生、健康管理、轻问诊、患者教育等服务。
Catalog of medical insurance (2019 Version) is released
On August 21st, the State Council issued the “National Medicine Catalogue of Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance (2019 version),” which will be implemented from January 1st, 2020. The “Medicine Catalogue” Indicates that each provincial Medical Insurance Bureau should bring all the drugs of the “Medicine Catalogue” into the “Centralised Procurement” and update the drug database according to the use of drugs in local medical institutions and retail pharmacies. Meanwhile, a national unified drug database should be established to realise the unified management of codes of western medicine, Chinese traditional medicine, and hospital-made medicines.
2019版国家医保目录正式发布
来源：医药网 2019.08.21
8月21日，国务院发布《国家基本医疗保险、工伤保险和生育保险药品目录》（以下简称《目录》），并自2020年1月1日起开始实施。《目录》要求，各省级医疗保障部门应及时将《目录》内药品纳入当地药品集中采购范围，并根据辖区内医疗机构和零售药店药品使用情况，及时更新完善药品数据库。同时，应建立完善全国统一的药品数据库，实现西药、中成药、中药饮片、医院制剂的编码统一管理。