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Archive for June, 2020

Tibet: supervising retail pharmacies

June 19th, 2020 | by

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

June 19th, 2020 | by

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

June 19th, 2020 | by

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

June 19th, 2020 | by

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。

Price management in medical institutions

June 19th, 2020 | by

On January 2nd, the National Health Commission issued the “Standard of Price Management in Medical Institutions,” which will come into effect as the date of promulgation. The “Standard” indicates that medical institutions should establish a price management system that is consisted of several departments. Besides, the “Standard” stipulates that medical institutions should make several staffs supervise the medical costs and adjust unreasonable charges. Besides, medical institutions should establish a system that can analyze and manage the medical service cost and make the costs of common medical services public.

 

国家卫健委:医疗机构内部价格行为管理规定

来源:医药网  2020.01.06

1月2日,国家卫健委发布《医疗机构内部价格行为管理规定》,并将自发布之日起施行。《规定》提出,各医疗机构应到建立由多部门组成的价格管理体系。《规定》要求,医疗机构应配备一定数量医疗服务价格工作人员,用于定期检查患者花费,纠正医院不规范收费;各医疗机构应建立医疗服务成本测算和成本控制管理制度,同时公示常用医疗服务项目的价格。