Schlagwort: ‘Government Supervision’
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。
Implementing online medical insurance settlement of prescriptions
On May 20th, the “Opinion on Settling the Price and Medical Insurance Payment of ‘Internet+’ Medical Services” issued by the Healthcare Security Administration of Chongqing province came into effect. The “Opinion” stipulates that for the pilot program of the “Internet+” medical insurance services for common and chronic diseases, doctors can issue electronic prescriptions after online consultations and settle up the medication costs online through medical insurance, and it is allowed to deliver medicines to patients in many ways.
线上处方医保支付落地！处方流转迎来新机遇！
来源：医药网 2020.05.21
5月20日，重庆市医疗保障局《关于“互联网+”医疗服务价格和医保支付政策的实施意见》开始实施。《意见》提出，对于正在试点的常见病、慢性病“互联网+”医保服务，患者通过网上问诊后，可由医生开出电子处方，医保在线结算，并且允许通过多种方式为患者进行配送。
Zhejiang: restricting the medication costs
On May 11th, the Medical Insurance Bureau of Zhejiang Province issued the “Regulations of DRGs Payment on Hospitalization Expenses of Basic Medical Insurance in Zhejiang Province and Hangzhou.” The “Regulation” clarifies that designated medical institutions can retain 85% of the settlement balance of medical insurance fund while they should pay 85% of the overspending. Moreover, the “Regulation” stipulates that designated medical institutions should restrict the cost of drugs, materials, and diagnosis and treatment services that are paid by inpatients on their own, which should be within 15% of their medical cost.
浙江医保新政策：医院要砍品种了 严控药费
来源：医药网 2020.05.14
5月11日，浙江省医保局印发《浙江省省级及杭州市基本医疗保险住院费用DRGs点数付费实施细则（试行）》。《细则》明确，2020年度医保基金年度结算结余部分的85%由定点医疗机构留用；超支部分的85%由定点医疗机构分担。《细则》要求，定点医疗机构应合理控制住院病人自费的药物、材料和诊疗项目费用，个人政策范围外费用比例原则上应控制在15%以内。
Hospitals and pharmacies should pay the drug cost within 30 working days
On May 12th, the NMPA issued the “Notification on Issuing the List of National Medical Security Management Services.” The “Notification” stipulates that medical institutions including hospitals and pharmacy chains should pay the drug cost for distributors and manufacturers within 30 working days.
国家医保局：定点医院、药店费用结算时限不超过30个工作日
来源：医药网 2020.05.13
5月12日，国家医保局发布《关于印发全国医疗保障经办政务服务事项清单的通知》。《通知》明确，定点医疗机构（含医疗机构、零售药店）费用结算办理时间应不超过30个工作日。
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。
Video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs
On April 17th, the NMPA held the video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs by centralized procurement of drugs with defined quantities. The conference stipulated that manufacturers should produce selected drugs according to the manufacturing processes that are defined by the NMPA. Besides, the Marketing Authorization Holders are encouraged to establish a mature drug traceability system to conform to the tracing requirement of “one-code-for-one-drug.”
落实中选药品“一物一码”带量采集专项检查视频会召开
来源：医药网 2020.04.23
4月17日，国家药监局召开国家组织药品集中采购和使用中选药品专项检查工作调度视频会议。会议要求，企业应按照药监部门核准的生产工艺生产中选药品；督促药品上市许可人建立完善信息化追溯体系，落实中选药品“一物一码”追溯要求。
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。
The “One Invoice Policy” will be implemented
On March 5th, the State Council issued a document on reforming the medical and health care system. The document indicates that a regional and a national allied procurement system should be implemented to realize an orderly drug supply system with reasonable prices and competition; medical insurance agencies should deal with the settlement payment directly with manufacturers or pharmaceutical companies. Besides, provincial centralized procurement platforms that are based on medical insurance payment should be established, which combines bidding, procurement, trading, settlement, and supervision.
国务院：推行一票制 经销商结款方式要变了
来源：医药网 2020.03.09
3月5日，国务院官网发布医疗保障制度改革文件。文件提出，将推进构建区域型、全国性联盟采购机制，形成竞争充分、价格合理、规范有序的供应保障体系；推进由医保经办机构直接与药品生产或流通企业结算货款；应以医保支付为基础，建立招标、采购、交易、结算、监督一体化的省级招标采购平台。