Archive for March, 2020
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。
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。