Kategorie: ‘Other Hot Topics’
Solicting opinions on drug recall
On October 13th, the NMPA issued the “Measures on Drug Recall (Consultation Paper)” to solicit opinions from public. The Consultation Paper stipulates that Markeiting Authorization Holders should establisch and improve the drug recall system, collect information on drug safety issues, and investigate and evaluate defective or potentially harmful drugs in order to recall them on time.
公开征求《药品召回管理办法（征求意见稿）》
来源：医药网 2020.10.14
10月13日，国家药监局综合司公开征求《药品召回管理办法（征求意见稿）》。《征求意见稿》要求，药品上市许可持有人应当建立并完善药品召回制度，收集药品安全的相关信息，对可能存在缺陷的药品进行调查、评估，及时召回缺陷药品。
NMPA: establishing a traceabiliy system of specially regulated drugs
On August 28th, the NMPA issued the “Notice of establishing the traceability system of special drugs.” The Notice indicates that the Marketing Authorization Holders should establish traceability systems and collect the information from the traceability process to realise the traceability of special regulated drugs, such as selected drugs, before December 31st. At the meantime, the NMPA should establish a Coordination Platform of traceability systems, which provides coding rules of drug traceability codes and services that encode the IP-Adresse of traceability systems that are established by Marketing Authorization Holders to help to realise the information sharing between the different traceability systems.
国家药监局：做好重点品种信息化追溯体系建设工作
来源：医药网 2020.10.14
8月28日，国家药监局发布《关于做好重点品种信息化追溯体系建设工作的公告》。《公告》指出，药品上市许可持有人应建立信息化追溯系统并收集全过程追溯信息，于2020年12月31日之前，基本实现国家药品集中采购中选品种等重点品种可追溯。同时，国家药监局应建设药品追溯协同服务平台，协同平台提供药品追溯码编码规则备案和药品上市许可持有人药品信息化追溯系统地址解析服务，辅助实现不同追溯系统互通互享。
Coding rules for chinese traditional drugs
On September 25th, the NMPA issued the “Coding Rules of Chinese Traditional Drugs Included in the Reimbursement List and Pharmaceutical Preparations of Medical Institutions.” The code of Chinese traditional drugs consists of 10 digits and four sections. The first section represents Chinese traditional drugs. The second section represents different medical standards in different cities. The third section represents drug effects. The fourth section represents the name of drug. The code of pharmaceutical preparation of medical institutions consists of 16 digits and 4 sections. The first section represents pharmaceutical preparations. The second section represents different medical institutions in different cities. The third section represents medical institutions. The fourth section represents the sequence of pharmaceutical preparations in different medical institutions.
医保药品中药饮片和医疗机构制剂统一编码规则和方法
来源：医药网 2020.09.27
9月25日，国家医保局印发了《医保药品中药饮片和医疗机构制剂统一编码规则和方法》。中药饮片分为4个部分共10位。其中，第1部分是中药饮片识别码，第2部分是标准分类码，第3部分是功效分类码，第4部分是中药饮片名称码。医疗机构制剂编码分4个部分16位。其中，第1部分是医疗机构制剂识别码，第2部分是行政区划代码，第3部分是定点医疗机构顺序码，第4部分是医疗机构制剂顺序码。
The State Council: encouraging online drugs trade, prescription sharing and online medical consulting services
On September 21st, the State Council issued the “Opinions on Accelerating the Development of Consumption Created by New Forms of Bussiness”. The “Opinion” stipulates that a public service platform of online and e-commerce services should be established and improved to accelerate the integration of online and offline services; online medical services should be developed, which means scheduled appointments of consulting services, online medical consulting services, prescription sharing and online drugs trade will be promoted.
国务院力挺网络售药、处方流转、互联网医疗
来源：医药网 2020.09.23
9月21日，国务院办公厅印发《关于以新业态新模式引领新型消费加快发展的意见》（以下简称《意见》）。《意见》要求，应建立健全“互联网+服务”、电子商务公共服务平台，加快社会服务在线对接、线上线下深度融合；积极发展互联网健康医疗服务，大力推进分时段预约诊疗、互联网诊疗、电子处方流转、药品网络销售等服务。
Pharmacy chains can only rise the price of drug in the reimbursement list by 15%
On September 1st, the “Reform Project on Improving the Functions of the Centralised Drug Procurement Platform and Promoting a Full Coverage of Payment Requirement of Drugs on the Reimbursement List in Zhejiang Province” was implemented. The “Project” indicates that drugs included in the list of online transactions on the provincal procurement platform of drugs and medical equipments are included in the provincal drug reimbursement list. Designated public medical institutions and private medical institutions should fix the drug price that accords with the price on the drug reimbursement list while pharmacy chains can rise the price upto 15% based on the price on the list.
9月1日起执行：医保用药 药店只能加价15%
来源：医药网 2020.09.03
9月1日，《浙江省提升药品集中采购平台功能推进医保药品支付标准全覆盖改革方案》正式实施。《方案》明确，所有纳入该省药械采购平台在线交易的医保目录内药品均纳入医保支付范围。其中，定点公立医疗机构与民营医疗机构医保药品执行相同的支付标准，定点零售药店医保支付标准统一按医疗机构支付标准上浮15%。
Prohibiting hospitals from designating drug delivery companies and pharmacies
On July 6th, the Health Commission of Gungxi and other seven departments jointly issued the “Notice on Strengthing the Medication Management in Medical Institutions to Promote Rational Use of Medicines”. The “Notice” clarifies that medical institutions supporting Prescription Sharing should establish a process and supervision system of Prescription Sharing and are prohibited from designating drug delivery companies and pharmacies to avoid monopolies organised by distribution companies and pharmacies; the shared prescriptions should be approved by medical institutions and included into the services of prescription management, supervision of medication, and guidance on rational use of medicines.
七部门：杜绝医药统方 严禁医院指定配送企业和药店
来源：医药网 2020.07.08
7月6日，广西自治区卫健委等七部门发布《关于进一步做好医疗机构药事管理促进合理用药工作的通知》（以下简称《通知》）。《通知》明确，开展处方外配的医疗机构应建立处方外配流程和监管制度，严禁指定药品配送企业和药店，避免配送企业和药店垄断药品销售；外配处方应经医疗机构审核，并纳入处方点评、用药监测和合理用药指导等药学服务范围。
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。