中国药品认证委员会认证管理办法

第一条 根据中国药品认证委员会的性质和任务,依据《药品管理法》、《产品质量认证管理条例》的有关规定,特制定本办法。 第二条 为促进药品生产全面实施《药品生产质量管理规范》(简称GMP),保证药品质量、安全和有效,参与国际药品贸易竞争和国际药品贸易中签证体制,国家对药品实行GMP认证制度。 第三条 认证委员会承担中华人民共和国境内药品生产企     

2006年度我国主要贸易伙伴技术壁垒、卫生与植物卫生措施实施情况回顾(连载三)

13 哈萨克斯坦 从2005年开始，哈萨克斯坦开始建立新的标准化和认证体系，制定颁布了《关于技术法规的法律》、《关于确保计量一致性的法律》、《哈萨克斯坦强制性产品合格确认的法律》以及其他相关的支持性法规。这些新法律法规旨在区分国家和私人部门之间的职责，规定由政府负责产品安全，私人部门负责质量管理。根据这些新规定，哈萨克斯坦对部分产品及服务实行强制认证制度，包括机械、汽车、农业设备、服装、玩具、食品和药品。但是，哈萨克斯坦对进口产品的检验和认证仍然主要由哈标准、计量和认证委员会及下属的认证机构进行，其检验和认证标准并不公开，程序也非常复杂。     

药物的不良反应与小儿用药之规定

小儿由于肝、肾功能较差,血脑屏障发育不健全,药物常常对小儿造成损害。在《中国药典》九五版中规定小儿慎用、禁用的药品制剂共计63种,占收载药品的4.34％。本文参阅《中国药典》及《国家基本药物目录》,对小儿用药之规定及药物的不良反应分述如下,以供用药时参考。1 抗感染药1.1 四环素类 包括盐酸四环素、盐酸土霉素、盐酸多西环素(实为脱氧土霉素)、盐酸美他环素。本类药物能与新形成的骨、     

住院医师规范化培训将有“国标”

国家卫生和计划生育委员会网站发布《住院医师规范化培训标准(试行)》草案,向社会公开征求意见。《标准》提出,住院医师规范化培训是培养合格临床医师必经的毕业后医学教育阶段,为期3年的住院医师规范化培训以临床实践培训为重点,取得培训合格证书将逐步作为临床医师在医疗机构独立从事诊疗工作和进入专科医师培训以及中级职称晋升的必备条件。为尽快全面建立和实施住院医师规范化培训制度,进而为建立实施专科医师培训制度奠定基础,国家卫生计生委委托中国医师协会组织专家制定了《住院医师规范化培训标准(试行)》。该《标准》包括培训总则和     

卫生部关于印发《单采血浆站质量管理规范》的通知

卫医发〔2006〕377号各省、自治区、直辖市卫生厅局,新疆生产建设兵团卫生局:根据《血液制品管理条例》、《中国遏制与防治艾滋病行动计划(2006-2010)》的规定,我部制定了《单采血浆站质量管理规范》。现印发给你们,请遵照执行。二○○六年九月十八日单采血浆站质量管理规范第一章总则第一条根据《中华人民共和国药品管理法》、《中华人民共和国传染病防治法》、《血液制品管理条例》、《艾滋病防治条例》、《中国遏制与防治艾滋病行动计划(2006-2010年)》、《单采血浆站基本标准》和《中华人民共和国药典》等有关规定,制定本规范。第二条本…     

医疗机构药品集中招标采购试点工作若干规定

一、为规范医疗机构药品购销活动 ,提高药品采购透明度 ,遏制药品流通领域不正之风 ,减轻社会医药费用负担 ,保证城镇职工基本医疗保险制度顺利实施 ,依据国务院办公厅转发国务院体改办等部门《关于城镇医药卫生体制改革的指导意见》,按照《中华人民共和国招标投标法》,结合药品采购工作的特点 ,制定本规定。二、县及县以上医疗机构药品集中招标采购试点工作必须遵守本规定。三、医疗机构是药品招标采购的行为主体。具有编制招标文件和组织评标能力的医疗机构可自行组织或数家医疗机构联合组织招标采购 ,也可委托招标代理机构开展招标采购。…     

医疗机构药品集中招标采购试点工作若干规定

一、为规范医疗机构药品购销活动 ,提高药品采购透明度 ,遏制药品流通领域不正之风 ,减轻社会医药费用负担 ,保证城镇职工基本医疗保险制度顺利实施 ,依据国务院办公厅转发国务院体改办等部门《关于城镇医药卫生体制改革的指导意见》 ,按照《中华人民共和国招标投标法》 ,结合药品采购工作的特点 ,制定本规定。二、县及县以上医疗机构药品集中招标采购试点工作必须遵守本规定。三、医疗机构是药品招标采购的行为主体。具有编制招标文件和组织评标能力的医疗机构可自行组织或数家医疗机构联合组织招标采购 ,也可委托招标代理机构开展招标采购…     

基层医院应加强有效期药品的管理

基层医院应加强有效期药品的管理湖北枝江紫荆岭铁路医院（４４３２１２）谭艳菊药品有效期是指在特定的贮藏条件下，该药品质量能符合《中国药典》或有关规定所要求的标准的最长期限。国家卫生部在１９９０年对１１９种抗生素、生化制品的有效期限作了规定，现又把没有注...     

刊中刊

《中国药典》第五版(1995年版)于10月20日正式发行,1996年4月1日正式执行。 《中国药典》是国家为保证药品质量,保障人民用药安全有效而制定的法典,是《药品管理法》监督检查药品质量的重要技术法规,是药品生产、供应、使用和管理的依据。     

药品单独定价论证会试行办法

各省、自治区、直辖市及计划单列市计委、物价局: 根据我委《关于单独定价药品价格制定有关问题的通知》(计价格(2001)13号)的有关规定,我们研究制定了《药品单独定价论证会试行办法》和《化学药品单独定价申报评审指标体系(试行)》,现印发给你们,请遵照执行。 附件:一、药品单独定价论证会试行办法 二、化学药品单独定价申报评审指标体系(试行)。 附件一: 药品单独定价论证会试行办法 第一条 为提高药品单独定价工作的透明度和科学性,规范药品单独定价专家论证会程序,制定本办法。 第二条 参加专家论证会的人员,为国家计委邀请的专家、申报企业代表和国家计委有关工作人员。 第三条 参加药品单独定价论证会的专家为从业时间较     

WHO Expert Committee on Specifications for Pharmaceutical Preparations

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.     

JCI标准特点解析及其对中国医院评审的影响

《美国医疗机构评审国际联合委员会医院评审标准》（简称《JCI标准》）是国际上公认的先进医疗服务标准。本文系统的介绍了“美国医疗机构评审国际联合委员会”JCI及《JCI标准》的历史、理念、特点及内容,并对《JCI标准》的特点进行了解析,同时将其与《三级综合医院评审标准实施细则》（2011年版）的理念、方法及内容进行了比较分析。强调我国医疗机构借鉴和使用《JCI标准》有利于提高医疗服务水平,促进医疗安全。     

功利主义学说与英国现代公共卫生改革先驱:杰里米·边沁

杰里米·边沁(Jeremy Bentham,1748—1832)是英国著名哲学家、法学家、政治理论家和社会改革家。他通过提出功利主义思想并将其应用于社会改革,成为英国公共卫生立法和司法改革运动的先驱。此外,他关注医学基础理论和实践应用的发展,对后世预防医学组织架构的确立、科研经费的获取和药典标准的国际化等多个方面产生了深远的影响。     

Academy of Nutrition and Dietetics: Revised 2017 Standards of Practice in Nutrition Care and Standards of Professional Performance for Nutrition and Dietetics Technicians,Registered

Nutrition and dietetics technicians, registered (NDTRs) face complex situations every day. Competently addressing the unique needs of each situation and applying standards appropriately are essential to providing safe, timely patient-/client-/customer-centered quality nutrition and dietetics care and services. The Academy of Nutrition and Dietetics (Academy) leads the profession by developing standards that can be used by NDTRs (who are credentialed by the Commission on Dietetic Registration) for self-evaluation to assess quality of practice and performance. The Standards of Practice reflect the NDTR’s role under the supervision of registered dietitian nutritionists in nutrition screening and the Nutrition Care Process and workflow elements, which includes nutrition screening, nutrition assessment, nutrition diagnosis, nutrition intervention/plan of care, nutrition monitoring and evaluation, and discharge planning and transitions of care. The Standards of Professional Performance consist of six domains of professional performance: Quality in Practice, Competence and Accountability, Provision of Services, Application of Research, Communication and Application of Knowledge, and Utilization and Management of Resources. Within each standard, indicators provide measurable action statements that illustrate how the standard can be applied to practice. The Academy’s Revised 2017 Standards of Practice and Standards of Professional Performance for NDTRs along with the Academy/Commission on Dietetic Registration Code of Ethics, and the Scope of Practice for the NDTR provide minimum standards and tools for demonstrating competence and safe practice, and are used collectively to gauge and guide an NDTR’s performance in nutrition and dietetics practice.     

SWOT分析在标准协调管理部门的应用

标准化工作已成为重要的国家级战略.标准在医疗卫生领域发挥着规范指引的作用,医疗卫生标准保障着医疗安全,推动着医疗技术高质量发展.国家卫生健康委医疗管理服务指导中心标准管理处作为标准协调管理部门,在医疗卫生标准的协调管理、制订修订、贯彻宣贯、追踪评价等方面发挥着重要的作用.本文运用SWOT分析法对国家卫生健康委医管中心标...     

Improving the nutritional status of older residents in care – new national minimum standards

Summary On 1st April 2002, national minimum standards for care homes for older people came into force in England and Wales ( Department of Health 2002 ). These were published in accordance with the Care Standards Act 2000 and replaced the Registered Homes Act of 1984. The Care Standards Act also created the National Care Standards Commission (NCSC), an independent non-governmental public body to regulate social and health care services (previously regulated by local councils and health authorities). Meeting the new standards is a core requirement for all care homes providing accommodation and nursing or personal care for older people and will form the basis on which the new NCSC will determine whether homes for older people meet the needs and secure the welfare and social inclusion of those who live in them. Several of the key topics highlighted in the Act relate explicitly to food and food provision (including health and personal care, daily life and social activities and staffing). For example, specifications are made about the type of food that is acceptable, when it should be eaten, the appropriate number of meals per day and their distribution throughout the day. This article outlines the main nutrition related issues in the new standards and highlights some available resources that may help care home owners to meet them.     

不同来源的甘草质量分析研究

目的:通过HPLC法,对乌兹别克斯坦、内蒙古共14批甘草中的甘草苷、甘草酸有效成分含量进行测定,并作出质量一致性评价。方法:按照2015版《中国药典》中甘草的有效成分含量检测方法,将甘草中甘草酸和甘草苷的含量作为检测指标,评价14批不同来源中甘草的质量。结果:包头3号、包头5号、内蒙古家种甲级、内蒙古家种丙级、内蒙古家种丁级、乌兹别克斯坦野生1号及乌兹别克斯坦野生2号药材甘草苷含量未达到药典标准(甘草苷含量>0.5%),包头家种2号、内蒙古浮草、、内蒙古家种甲级、内蒙古家种丙级、内蒙古家种丁级甘草酸含量均达到药典标准(甘草酸含量>2.0%),其余样品均符合2015版药典标准。结论:国外及内蒙古各批次甘草中甘草苷、甘草酸铵的含量存在较大差异,以内蒙古包头家种1号样品最佳。     

Das Arzneibuch

The pharmacopoeia is an official collection of approved pharmaceutical standards. In addressing anyone who produces, distributes or controls medicinal products it comprises requirements on the quality of medicinal products and of the substances used to manufacture them. Moreover, it provides quality control methods. It is therefore an important component of the drug safety system and thus an instrument for patient and consumer protection. How ever, the trend to outsource the production of raw materials to countries outside Europe is often associated with altered production procedures and may have severe consequences. Unwanted side effects of medicinal products--caused by quality changes of the raw materials--may occur. However, this peril can be significantly reduced by consistently adapting the provisions of the pharmacopoeia to the evolution of the drug market.     

Short-term effectiveness of an outcomes research training curriculum within a coordinated program

The fourth edition of the Commission on Accreditation for Dietetics Education Standards of Education mandated outcomes research training. Our objective was to determine the short-term effectiveness (<5 years) of the outcomes research training curriculum in the Coordinated Program in Dietetics (CP) at the University of Missouri-Columbia, which exceeds these minimum standards. Toward this end, a survey tool was administered to University of Missouri-Columbia CP graduates before the implementation of the fourth edition of Standards of Education and to University of Missouri-Columbia CP graduates with two semesters of outcomes research training; graduates of two other CPs from different universities from the same years were also surveyed. Graduates who went through CPs after implementation of the fourth edition of the Standards of Education showed notable improvement in attitudes, interest, and participation in most of the outcomes research skills queried, compared with those who completed their education under the earlier standards; knowledge was only slightly improved. Of these areas, only enhancements in attitudes and interest were consistently more pronounced in food and nutrition professionals trained using the University of Missouri-Columbia's outcomes research curriculum compared with other CP graduates. Both the Commission on Accreditation for Dietetics Education and program directors can use the findings described herein to further assess and develop the research competencies and/or to strengthen their programs.     

中药材市场部分中药材的调查分析

目的为进一步规范中药材市场,正确使用中药材,保障人民用药安全有效。方法以《中国药典》（2005年版一部）以及《广东省中药材标准》（第一册）为依据,对广州市中药材市场上流通的中药材进行调查、比较和鉴别。结果发现16种常用中药材的来源与《中国药典》或《广东省中药材标准》收载的品种存在差异;另外,部分中药材名称不规范。结论务必正本清源,正确使用《中国药典》和《广东省中药材标准》规定的中药材,合理使用广东习用药材,防止混用和误用。