各国药监局网站
收藏各国的原研药品信息查询方法

收藏| 各国的原研药品信息查询方法一:FDA查原研产品信息1、FDA drug进入链接,搜索药物名称,点击申请号,看Approval History, Letters, Reviews, and Related Documents点击进入,拉到最底下,最早时间—approval 右侧一栏,review,点击可看到如下信息· Approval Letter(s) (PDF) · Printed Labeling (PDF) ·Medical Review(s) Part 1 (PDF) Part 2 (PDF)· Chemistry Review(s) (PDF) ·Pharmacology Review(s) Part 1 (PDF) Part 2 (PDF)· Statistical Review(s) (PDF)· Clinical Pharmacology Biopharmaceutics Review(s) (PDF) ·Administrative Document(s) Part 1 (PDF) Part 2 (PDF)·Correspondence (PDF)通常要看Clinical Pharmacology Biopharmaceutics Review(s)和说明书labeling,可获知信息包括处方所有辅料,review里可能还有溶出度的部分数据。
二:EMA欧盟药监-链接如下anding_page.jsp&mid=搜索药名,在human medicine项下出现1 medicine that has a european public assessment report 1 Paediatric investigation plan/ waiver (可能有时无)点击进入,看到如下4项About, Authorisation details, Product information, Assessment history.Product information下,选择语言为英语的pdf下载,Assessment history里面最有用的应该是Scientific Discussion,会告诉你大概的制备工艺,湿法制粒还是干法制粒等。
各国药监局网站

各国药监局网站U.S.:Food and Drug Administration(美国:食品和药品管理局)UK: Medicines and Healthcare Products Regulatory Agency(英国:药物和保健产品监管署)UK: Medical Devices Agency(英国:医疗器械署)Ukraine: Ministry of Health(乌克兰:卫生部)Sweden: Medical Products Agency(瑞典:药品署)Spain: Spanish Drug Agency(西班牙:西班牙药物署)India: Agricultural and Processed Food Products Export Development Authority(印度:农产和加工食品出口发展局)India: Ministry of Health and Family Welfare(印度:卫生和家庭福利部)India: Ministry of Food Processing Industries(印度:食品加工产业部)India: Ministry of Consumer Affairs, Food & Public Distribution(印度:消费者事务、食品和公共分配部)UK: National Institute for Biological Standards and Control(英国:国家生物学标准和管制所)UK: Department of Health(英国:卫生部)Turkey: Ministry of Health(土耳其:卫生部)Switzerland: Federal Veterinary Office(瑞士:联邦兽医办公室)Switzerland: Agency for Therapeutic Products(瑞士:治疗产品署)Switzerland: Federal Office of Public Health(瑞士:联邦公共卫生办公室)Sweden: National Board of Health and Welfare(瑞典:国家卫生与福利委员会)Spain: Ministry of Health and Consumption(西班牙:卫生与消费部)Slovenia: Institute of Public Health(斯洛文尼亚:公共卫生所)Slovenia: Ministry of Public Health(斯洛文尼亚:公共卫生部)Slovak Republic: State Institute for Drug Control(斯洛伐克共和国:国家药物管制所)San Marino: Ministry of Health and Social Security(圣马力诺:卫生与社会保障部)UK: Food Standards Agency(英国:食品标准署)UK: Veterinary Medicines Directorate(英国:兽药理事会)Papua New Guinea: Department of Health(巴布亚新几内亚:卫生部)Philippines: Department of Health(菲律宾:卫生部)Philippines: National Food Authority(菲律宾:国家食品局)Singapore: Ministry of Health(新加坡:卫生部)Singapore: Health Sciences Authority(新加坡:卫生科学局)Singapore: Ministry of Environment(food control)(新加坡:环境部[食品管制])Singapore: Agri-food and Veterinary Authority(新加坡:农产食品和兽医局)Sri Lanka: Ministry of Health ,Nutrition & Welfare(斯里兰卡:卫生、营养和福利部)Thailand: Ministry of Public Health(泰国:公共卫生部)Thailand: Food and Drug Administration(泰国:食品药品管理局)New Zealand: Medicines and Medical Devices Safety Authority(新西兰: 药物和医疗器械安全局)New Zealand: Ministry of Health(新西兰:卫生部)Korea: Food and Drug Administration(韩国:食品药品管理局)Malaysia: National Pharmaceutical Control Bureau(马来西亚:国家药品管制局)Japan: Pharmaceuticals and Medical Devices Evaluation Center(日本:药品和医疗器械评价中心)Indonesia: Ministry of Health(印尼:卫生部)Russian Federation: Ministry of Public Health(俄罗斯:公共卫生部)Romania: Ministry of Health and the Family(in Romanian)(罗马尼亚:卫生与家庭部)Portugal: Ministry of Health(葡萄牙:卫生部)Poland: Drug Institute(波兰:药物所)Poland: Ministry of Health and Social Security(波兰:卫生与社会保障部)Norway: Norwegian Medicines Agency(挪威:挪威药物署)Norway: Norwegian Board of Health(挪威:挪威卫生委员会)Norway: Ministry of Health and Social Affairs(挪威:卫生与社会事务部)Netherlands: Inspectorate for Health Protection and Veterinary Public Health(荷兰:健康保护和兽医公共卫生检查处)Netherlands: Medicines Evaluation Board(荷兰:药物评价委员会)Netherlands: Ministry of Health, Welfare and Sport(荷兰:卫生、福利与体育部)Malta: Ministry of Health(马耳他:卫生部)Luxembourg: Ministry of Health(卢森堡:卫生部)Lithuania: State Medicines Control Agency(立陶宛:国家药物管制署)Lithuania: Ministry of Health(立陶宛:卫生部)Latvia: State Agency of Medicines(拉脱维亚:国家药物署)Italy: National Institute of Health(意大利:国家卫生所)Italy: Ministry of Health(意大利:卫生部)Ireland: Medicines Board(爱尔兰:药物委员会)Ireland: Department of Health and Children(爱尔兰:卫生与儿童部)Iceland: Environmental and Food Agency(冰岛:环境与食品署)Iceland: Medicines Control Agency(冰岛:药物管制署)Hungary: National Institute of Pharmacy(匈牙利:国家药房所)Hungary: Ministry of Health, Social and Family Affairs(匈牙利:卫生、社会与家庭事务部)Greece: Hellenic Food Authority(希腊:希腊食品局)Greece: National Organization for Medicines(希腊:国家药物组织)Greece: Ministry of Health and Welfare(希腊:卫生与福利部)Germany: Federal Institute for Drugs and Medical Devices(德国:联邦药物与医疗器械所)Germany: Ministry of Health(德国:卫生部)Georgia: Ministry of Labor, Health and Social Security(格鲁吉亚:劳动、卫生和社会保障部)France: National Agency for Veterinary Medicinal Products(法国:国家兽用药品署)France: General Directorate of Competition, Consumption and Repression of Fraud(food control)(法国:竞争、消费和抑制欺诈总理事会[食品管制])France: Sanitary Safety of Health Products Agency(法国:健康产品卫生安全署)France: Ministry of Health(法国:卫生部)Finland: National Food Agency(芬兰:国家食品署)Finland: National Agency for Medicines(芬兰:国家药物署)Finland: Ministry of Social Affairs and Health(芬兰:社会事务和卫生部)Denmark: Veterinary and Food Administration(丹麦:兽医和食品管理局)Estonia: State Agency of Medicines(爱沙尼亚:国家药物署)Denmark: Medicines Agency(丹麦:药物署)Denmark: Ministry of Health(丹麦:卫生部)Czech Republic: State Institute for Drug Control(捷克共和国:国家药物管制所)Czech Republic: Ministry of Health(捷克共和国:卫生部)Croatia: Ministry of Health(克罗地亚:卫生部)Bulgaria: Drug Agency(保加利亚:药物署)Bulgaria: Ministry of Health(保加利亚:卫生部)Belgium: Federal Agency for the Safety of the Food Chain(比利时:联邦食物链安全署)Belgium: Pharmaceutical Inspectorate(比利时:药品检查处)Armenia: Drug and Medical Technology Agency(亚美尼亚:药物和医学技术署)Armenia: Ministry of Health(亚美尼亚:卫生部)Andorra: Ministry of Health and Welfare (安道尔:卫生与福利部)European Commission: DG Fisheries(欧洲委员会:DG渔业)European Commission: DG Agriculture(欧洲委员会:DG农业)European Commission: DG Enterprise: Pharmaceuticals and Cosmetics(欧洲委员会:DG企业:药品和化妆品)European Commission: DG Enterprise(欧洲委员会:DG企业)European Agency for the Evaluation of Medicinal Products(欧洲药品评价署)United Arab Emirates: Federal Department of Pharmacies(阿拉伯联合酋长国:联邦药房部)United Arab Emirates: Ministry of Health(阿拉伯联合酋长国:卫生部)Saudi Arabia: Ministry of Health(沙特阿拉伯:卫生部)Palestinian Authority: Ministry of Health(巴勒斯坦:卫生部)Lebanon: Ministry of Health(黎巴嫩:卫生部)Jordan: Ministry of Health(约旦:卫生部)Israel: Ministry of Health(以色列:卫生部)Zimbabwe: Ministry of Health and Child Welfare(津巴布韦:卫生与儿童福利部)Uganda: Ministry of Health(乌干达:卫生部)Tunisia: Office of Pharmacy and Medicines(突尼斯:药房与药物办公室)Tunisia: Ministry of Public Health(突尼斯:公共卫生部)Swaziland: Ministry of Health and Social Welfare(斯威士兰:卫生与社会福利部)South Africa: Department of Health(南非:卫生部)Morocco: Ministry of Public Health(摩洛哥:公共卫生部)Mauritius: Ministry of Health & Quality of Life(毛里求斯:卫生和生活质量部)Kenya: Ministry of Health(肯尼亚:卫生部)Botswana: Ministry of Health(博茨瓦纳:卫生部)Benin: Ministry of Health(贝宁:卫生部)Venezuela: Ministry of Health and Social Development(委内瑞拉:卫生与社会发展部)U.S.:Substance Abuse Prevention, Addictions Treatment and Mental Health Services(美国:药物滥用防止、毒瘾治疗与精神卫生局)U.S.:National Institutes of Health(美国:国家健康研究所)U.S.:National Agricultural Library USDA/FDA Foodborne Illness Education Information Center(美国:国家农业图书馆的USDA/FDA食源性疾病教育信息中心)Joint Institute for Food Safety and Applied Nutrition(食品安全和应用营养联合研究所)National Center for Toxicological Research(国家毒理学研究中心)Center for Veterinary Medicine(兽药中心)Center for Food Safety and Applied Nutrition(食品安全和应用营养中心)Center for Drug Evaluation and Research(药品评价和研究中心)Center for Devices and Radiological Health(器械和辐射健康中心)Center for Biologics Evaluation and Research(生物制品评价和研究中心)U.S.:Drug Enforcement Administration(美国:毒品强制执法管理局)U.S.:Department of Health and Human Services(美国:健康和人类服务部)U.S.:Centers for Disease Control and Prevention 美国:疾病控制与预防中心Uruguay: Ministry of Public Health(乌拉圭:公共卫生部)Trinidad & Tobago: Bureau of Standards(特立尼达和多巴共和国:标准局)Trinidad and Tobago: Ministry of Health(特立尼达和多巴共和国:卫生部)Peru: General Directorate of Pharmaceuticals, Devices and Drugs(秘鲁:药品,器械与药物理事会)Peru: Ministry of Health(秘鲁:卫生部)Panama: Ministry of Health(巴拿马:卫生部)Nicaragua: Ministry of Health(尼加拉瓜:卫生部)Netherlands Antilles: Department of Public Health and Environmental Protection(荷兰安的列斯群岛:公共卫生与环境保护部)Jamaica: Ministry of Health(牙买加:卫生部)Guyana: National Bureau of Standards(圭亚那:国家标准局)Guyana: Ministry of Health(圭亚那:卫生部)Guatemala: Ministry of Health(危地马拉:卫生部)El Salvador: Ministry of Public Health and Social Assistance(萨尔瓦多:公共卫生与社会援助部)Ecuador: Ministry of Public Health(厄瓜多尔:公共卫生部)Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos(哥伦比亚:INVIMA国家药物和营养警戒所)Colombia: Ministry of Health(哥伦比亚:卫生部)Brazil: National Health Surveillance Agency(巴西:国家卫生监督署)Brazil: Ministry of Health(巴西:卫生部)Bolivia: Ministry of Health and Social Welfare(玻利维亚:卫生与社会福利部)Belize: Ministry of Health(洪都拉斯:卫生部)Argentina: Ministry of Health(阿根廷:卫生部)Argentina: National Administration of Drugs, Foods and Medical Technology(阿根廷:国家药物、食品与医疗技术管理局)美国疾病控制中心。
欧洲药监局

欧盟植物药监管机构(发布日期:2011-4-18 9:53:01)浏览人数:96鼠标双击自动滚屏在欧盟,药品监管机构为欧洲药品审评管理局(European Agency for the Evaluation of Medicinal Products,EMEA),EMEA于1995年1月1日开始正式运作。
包括一个董事会和四个评审委员会:即人用药品委员会(CHMP)、兽用药品委员会(CVMP)、孤儿药委员会(COMP)和草药产品委员会(HMPC)。
2004年,EMEA更名为欧洲药品局(European Medicines Agency,EMA)。
但由于EMEA沿用已久,所以EMA的不少文件仍使用EMEA来代表EMA。
EMA主要负责欧盟市场药品的审查、批准上市,评估药品科学研究,监督药品在欧盟的安全性、有效性。
同时,还负责协调、检查、监督各成员国的GAP、GMP、GLP、GCP等工作。
2004年9月23日,欧盟根据2004/24/EC指令,正式成立了草药产品委员会(Committee for Human Medicinal Products,HMPC),专门负责对草药产品的审批和监管。
其主要具有以下三项职责:制定欧盟草药质量标准;制定欧盟草药物质、草药制品及其复方的目录;协调解决各成员国就传统草药注册提出的有关问题。
因此,该机构是欧盟草药管理的直接监管机构欧洲药品管理局(EMA)介绍2011年07月29日17:33阅读次数:[341]6月30日欧盟宣布,与克罗地亚完成谈判,克罗地亚将于2013年7月1日成为欧盟第28个成员国。
欧盟新一轮扩张即将来临,在欧盟委员会的领导下,对30个欧盟成员国及欧洲经济贸易自由区国家进行人用药品及兽药行驶监督管理权的欧洲药品管理局(EMA)是否准备好了?本期带您走进欧洲药监管理机构,了解EMA如何处理各种协调工作。
在欧洲,欧洲药品管理局(EMA)对新药上市许可提供科学审评意见,在与公共机构就欧洲主要公共卫生问题进行合作等方面承担重大责任。
各国的原研药品信息查询方法

各国的原研药品信息查询方法原研药品是指由制药公司自行研发并获得批准上市销售的药品,也被称为创新药品。
各国的原研药品信息查询方法可能会有所不同,下面将就几个主要国家来介绍各自的查询方法。
1.美国(FDA):美国食品药品监督管理局(Food and Drug Administration)是美国的药品监管机构。
他们在官方网站上提供了一个名为“药物信息”的在线查询平台,用户可以通过该平台并获取到相关的原研药品信息,包括药品的适应症、剂量、注意事项等。
2.欧洲(EMA):欧洲药品管理局(European Medicines Agency)是欧洲的药品监管机构。
他们在官方网站上提供了一个名为“药物数据库”的查询工具,用户可以通过该工具并获取到欧洲上市的原研药品的详细信息,包括药品的生产商、适应症、剂量、副作用等。
3.英国(MHRA):英国药品和医疗保健产品规管局(Medicines and Healthcare products Regulatory Agency)是英国的药品监管机构。
他们在官方网站上提供了一个名为“电子药物信息汇总”的在线查询平台,用户可以通过该平台并获取到在英国上市的原研药品的详细信息,包括药品的适应症、剂量、注意事项等。
4.日本:日本厚生劳动省(Ministry of Health, Labour and Welfare)是日本的药品监管机构。
他们在官方网站上提供了一个名为“新药信息”的在线查询平台,用户可以通过该平台并获取到日本上市的原研药品的详细信息,包括药品的适应症、剂量、副作用等。
5.中国:国家药品监督管理局是中国的药品监管机构。
他们在官方网站上提供了一个名为“国家药品信息查询”的在线查询平台,用户可以通过该平台并获取到国内上市的原研药品的详细信息,包括药品的适应症、剂量、副作用等。
此外,用户还可以通过中国知网等学术数据库查询到一些原研药品的研究论文和临床试验结果。
总而言之,各国的原研药品信息查询方法主要集中在各国的药品监管机构的官方网站上,用户可以通过在线查询平台并获取到相关的药品信息。
欧洲、中东、非洲和欧洲药品药监局EDQM

欧洲药品评价局EMEA和欧洲药品质量管理局(EDQM)介绍一九九四年经欧共体与欧洲议会协商后,以设在法国的欧洲药典委员会秘书处为基础成立了欧洲药品质量管理局(EDQM)。
相对于设在英国伦敦主要负责对新药和新生物制品审评的欧洲药品审评委员会(EMEA),EDQM主要功能之一是对上市后的仿制药品的监督管理,其主要监管手段是对产品的Certification of Suitability和对通过欧洲各国家官方药品检验所(OMCL)之间的欧洲网络系统来对药品的市场监督。
EMEA (European Medic ines uation Agency)翻译为欧洲药品评价局,其机构正在改革变化中,首先,EMEA将从现有的“欧洲药品评价局(European Medicines uation Agency,EMEA) 更名为“欧洲药品局(European Medicines Agency,EMA)“。
欧洲药品质量理事会EDQM (European Directorate for the Quality of Medicines)作为另一重要欧洲官方药管机构,欧洲药品质量管理局是由欧洲药典委员会技术秘书处演化而来,它有很多职能,具体职能如下:1、欧洲药典委员会的技术秘书处提供技术支持2、负责欧洲药典及相关产品的出版与发行3、负责化学药物标准品和生物制品标准品的制备与销售4、负责对欧洲药典各论的适用性认证5、负责构建欧洲官方药品检验实验室网络,承担生物制品批签发与上市药品的监督任务。
EMEA和EDQM之间的关系?欧洲药品评价局EMEA(European Agency for the uation of Medicinal Products)是欧洲官方药管机构之一,它有很多职能,其中很重要的一点就是负责药品(制剂)上市核准程序;而欧洲药品质量理事会EDQM(European Directorate for the Quality of Medicines)作为另一重要欧洲官方药事管理机构,它有很多职能,如:建立药品的质量标准以供欧洲药典委员会使用,制备标准品CRS,执行COS程序最终颁发COS证书等等。
各国药监局网站

各国药监局网站U。
S。
:Food and Drug Administration(美国:食品和药品管理局)http://www.fda。
govUK: Medicines and Healthcare Products Regulatory Agency(英国:药物和保健产品监管署)http://www.mca。
/home。
htmUK: Medical Devices Agency(英国:医疗器械署)http://www。
medical—devices。
Ukraine: Ministry of Health(乌克兰:卫生部)http://www。
.uaSweden: Medical Products Agency(瑞典:药品署)http://www。
mpa。
seSpain:Spanish Drug Agency(西班牙:西班牙药物署)http://www.msc.es/agemed/main。
htmIndia:Agricultural and Processed Food Products Export Development Authority(印度:农产和加工食品出口发展局)http://www。
India:Ministry of Health and Family Welfare(印度:卫生和家庭福利部)http://www.mohfw.nic。
inIndia: Ministry of Food Processing Industries(印度:食品加工产业部)http://www.mofpi.nic。
inIndia: Ministry of Consumer Affairs,Food &Public Distribution(印度:消费者事务、食品和公共分配部)http://www。
fcamin.nic。
inUK: National Institute for Biological Standards and Control(英国:国家生物学标准和管制所)http://www.nibsc。
世界各国药监局网站

List of Globally identified Websites of Medicines RegulatoryAuthorities ∗(as of November, 2009)AFRO ‐ Regional Office for Africa1.Algeria: http://www.ands.dz/pharmacie‐med/sommaire.htmpharmacovigilance: .dz/2.Angola: no website identified3.Benin: no website identified4.Botswana: .bw/ ‐ MoH ‐ no MRA5.Burkina Faso: .bf/SiteSante/ministere/sc/dgpml.html6.Burundi: website does not exist ‐ only MoH7.Cameroon: no website identified8.Cape Verde: no website identified9.Central African Rep: no website identified10.Chad: website does not existoros, The: no website identified12.Congo, The: no website identified13.Cote dʹIvoire: no website identified14.Democratic Republic of Congo: website does not exist15.Equatorial Guinea: no website identified16.Eritrea: website does not exist17.Ethiopia: .et/18.Gabon: website does not exist19.Gambia: no website identified20.Ghana: .gh/21.Guinea: no website identified22.Guinea‐Bissau: no website identified23.Kenya: /24.Lesotho: no website identified25.Liberia: no website identified26.Madagascar: no website identified27.Malawi: no website identified28.Mali: /29.Mauritania: no website identified30.Mauritius: .mu/portal/site/mih MIH ‐ no MRA∗ This list is indicative. WHO/EMP will be thankful for any correction and addition.31.Mozambique: website does not exist32.Namibia: .na/33.Niger: no website identified34.Nigeria: /35.Rwanda:.rw/index.php?option=com_content&view=article&id=6 2&catid=56:ministry‐taskforces&Itemid=136.Sao Tome & Principe: no website identified37.Senegal: http://www.sante.gouv.sn/ click ‐les directions‐ and then ‐La Directionde la Pharmacie et des Laboratoires (DPL)‐38.Seychelles: no website identified39.Sierra Leone: website does not exist40.South Africa: /41.Swaziland: MRA is being established .sz/home.asp?pid=9942.Togo: no website identified43.Uganda: http://www.nda.or.ug/44.United Republic of Tanzania: http://www.tfda.or.tz/45.Zambia: no website identified46.Zimbabwe: http://www.mcaz.co.zw/AMRO ‐ Regional Office for the Americas1.Antigua and Barbuda: no website identified2.Argentina: .ar/3.Bahamas: /hospitals_overview_bnda.php4.Barbados: no website identified5.Belize: no website identified6.Bolivia: .bo/snis/enlaces_salud/dinamed/index.htm7.Brazil: .br/eng/index.htm8.Canada: http://www.hc‐sc.gc.ca/dhp‐mps/index‐eng.php9.Chile: http://www.ispch.cl/10.Colombia: .co/11.Costa Rica: http://www.ministeriodesalud.go.cr/ MoH department withinformation on site12.Cuba: http://www.cecmed.sld.cu/13.Dominica: no website identified14.Dominican Republic: .do/15.Ecuador: no website identified16.El Salvador: no website identified17.Grenada: no website identified18.Guatemala:http://portal.mspas.gob.gt/regulacion_y_control_de_productos_farmaceuticos _y_afines.html MoH department with information on site19.Guyana: MoH department.gy/prg_adm_food_drugs.php20.Haiti: website does not exist21.Honduras: http://www.dgrs.gob.hn/22.Jamaica: / pharmacies and pharmacists, not medicines23.Mexico: http://www.cofepris.gob.mx/24.Nicaragua: no website identified25.Panama: http://www.minsa.gob.pa/ MoH department with information onsite26.Paraguay: .py/programas/index.php?id=627.Peru: http://www.digemid.minsa.gob.pe/28.Saint Kitts and Nevis: no website identified29.Saint Lucia: no website identified30.Saint Vincent and the Grenadines: no website identified31.Suriname: no website identified32.Trinidad and Tobago: .tt/sitepages/default.aspx?id=9333.United States of America: /34.Uruguay: http://www.msp.gub.uy/subcategorias_8_1.html35.Venezuela (Bolivarian Republic of): .ve/EMRO ‐ Regional Office for the Eastern Mediterranean1.Afghanistan: website does not exist ‐ only MoH2.Bahrain: no website identified3.Djibouti: no website identified4.Egypt: .eg/5.Iran (Islamic Republic of): no website identified6.Iraq: no website identified7.Jordan: http://www.jfda.jo/en/default/8.Kuwait: no website identified9.Lebanon: .lb/en/Drugs/DrugsListWithLinks.htm10.Libyan Arab Jamahiriya: no website identified11.Morocco: .ma/Medicaments/Pages/default.aspx12.Oman: .om/nv_menu.php?fNm=pharma/regulation.htm13.Pakistan: .pk/14.Qatar: .qa/moh/ under construction15.Saudi Arabia: .sa/En/Home/default.htm16.Somalia: no website identified17.Sudan: .sd/18.Syrian Arab Republic: no website identified19.Tunisia: http://www.dpm.tn/20.United Arab Emirates: .ae/en/Page_431.aspx21.Yemen: http://www.sbd‐/EURO ‐ Regional Office for Europe1.Albania: .al/2.Andorra: http://www.salutibenestar.ad/ MoH department with informationon site3.Armenia: http://www.pharm.am/index.php?langid=24.Austria: http://www.ages.at/ages/ueber‐uns/english‐what‐is‐ages/5.Azerbaijan: http://www.pharm.az/ under construction6.Belarus: http://www.rceth.by/7.Belgium: http://www.fagg‐afmps.be/8.Bosnia and Herzegovina: .ba/9.Bulgaria: http://www.bda.bg/10.Croatia: http://www.almp.hr/?ln=en&w=o_agenciji11.Cyprus:.cy/moh/phs/phs.nsf/dmlindex_en/dmlindex_en?opend ocument12.Czech Republic http://www.sukl.cz/13.Denmark: http://www.dkma.dk/14.EMEA: http://www.emea.europa.eu/ (also: DG Enterprise)15.Estonia: http://www.sam.ee/16.Finland: http://www.nam.fi/17.France: http://www.afssaps.fr/18.Georgia: /02/gdna/home/0,2803,132319894,00.html19.Germany: http://www.bfarm.de/gb_ver/ and: http://www.zlg.nrw.de/ andhttp://www.pei.de/EN/home/node‐en.html?__nnn=true20.Greece: http://www.eof.gr/web/guest/home21.Hungary: http://www.ogyi.hu/main_page/22.Iceland: http://www.imca.is/23.Ireland: http://www.imb.ie/24.Israel: .il/ MoH department with information on site25.Italy: .it/ andhttp://www.agenziafarmaco.it/section8983.html26.Kazakhstan: http://www.dari.kz/?lang=rus27.Kyrgyzstan: http://pharm.med.kg/tvia: .lv/index.php?setlang=en&large29.Lithuania: http://www.vvkt.lt/index.php?332772390330.Luxembourg: http://www.ms.public.lu/fr/activites/pharmacie‐medicament/index.html MoH department with information on site31.Malta: .mt/32.Monaco: no website identified33.Montenegro: /ulms/herlands: http://www.cbg‐meb.nl/35.Norway:http://www.legemiddelverket.no/templates/InterPage____16645.aspx?filterBy =CopyToGeneral36.Poland: .pl/37.Portugal: http://www.infarmed.pt/38.Republic of Moldova: http://www.amed.md/index_eng.html39.Romania:http://www.anm.ro/en/home.html40.Russian Federation: http://www.roszdravnadzor.ru/41.San Marino: no website identified42.Serbia: .rs/43.Slovakia: http://www.sukl.sk/en44.Slovenia: http://www.jazmp.si/index.php?id=5645.Spain: http://www.agemed.es/en/actividad/sgInspeccion/home.htm46.Sweden: kemedelsverket.se/english/47.Switzerland: http://www.swissmedic.ch/index.html?lang=en48.Tajikistan: under constructionhttp://health.tj/en/index.php?option=com_content&task=view&id=6&Itemid=749.The former Yugoslav Republic of Macedonia: no website identified50.Turkey: .tr/51.Turkmenistan: no website identifiedraine: http://www.pharma‐center.kiev.ua/view/en/index53.United Kingdom: /index.htm54.Uzbekistan: no website identifiedSEARO ‐ Regional Office for South‐East Asia1.Bangladesh: /2.Bhutan: .bt/dra.php3.DPR Korea: no website identified4.Democratic Republic of Timor Leste: website does not exist5.India: http://cdsco.nic.in/6.Indonesia: http://www.pom.go.id/e_default.asp7.Maldives: .mv/web/8.Myanmar: no website identified9.Nepal: .np/req_modern_medicine.php10.Sri Lanka: http://203.94.76.60/DRA/home.htm11.Thailand: http://www.fda.moph.go.th/eng/index.stmWPRO ‐ Regional Office for the Western Pacific1.Australia: .au/2.Brunei Darussalam:.bn/pharmacyservices/drugregistration.htm3.Cambodia: no website ‐ only MoH4.China: /a.China, Hong Kong Special Administrative Region:.hk/eps/index.jspb.China, Province of Taiwan: .tw/en/index.aspx5.Cook Islands: no website identified6.Fiji: .fj/FPS/insRA.html7.Japan: http://www.pmda.go.jp/english/index.html8.Kiribati: no website identifiedoʹs Peopleʹs Democratic Republic: no website identified10.Malaysia: .my/.my/index.cfm11.Marshall Islands: no website identified12.Micronesia, Federated States of: no website identified13.Mongolia: http://www.moh.mn/ MoH, .mn/ statespecialized inspection agency, .mn/ Department ofHealth14.Nauru: no website identified15.New Zealand: /16.Niue: no website identified17.Palau: no website identified18.Papua New Guinea: website does not exist19.Philippines: .ph20.Republic of Korea: http://ezdrug.kfda.go.kr/21.Samoa: no website identified22.Singapore: .sg/publish/hsaportal/en/home.html23.Solomon Islands: no website identified24.Tonga: no website identified25.Tuvalu: no website identified26.Vanuatu: no website identified27.Vietnam: .vn/Methodology of identifying websitesThe MRA websites were identified through the following means:-the list of 53 websites available from the WHO study of 2001;-available lists of MRAʹs in Europe(http://www.emea.europa.eu/Inspections/Links.html), Africa(/html/direction_de_la_pharmacie_et_d.html) and theAmericas (/directAutorid/home.htm);-an Internet search on (country name) plus DRA / drug authority / autoridad de medicamentos / autorité des medicaments, ministry of health / ministèrede santé / ministerio de salud / saude;-contacting the National Programme Officers (NPOʹs) and WHO Regional Offices of the Essential Medicines and Pharmaceutical Policies department(EMP).Links that were not working and websites that only mentioned the name of a MRA were not listed as MRA websites (links in black).The existence or nonexistence of websites could not be confirmed for some countries. No website identified means that through the above search methodology, no website was found. Website does not exist means that National Programme Officers have confirmed that there is no website.Acronyms:MoH = Ministry of HealthMRA = Medicines Regulatory Authority。
国外产品质量、食品安全相关信息网址

常用国外信息网址1、加拿大边境服务局(署)http://cbsa-asfc.gc.ca/menu-eng.html2、加拿大食品检验局http://www.inspection.gc.ca/eng/1297964599443/1297965645317 3、美国环保局/4、美国能源部/5、欧盟官方网站http://europa.eu/index_en.htm6、欧盟委员会网站http://ec.europa.eu/index_en.htm7、食品导航网/8、加拿大卫生部http://www.hc-sc.gc.ca/index-eng.php10、化学观察/9、英国食品标准局/10、澳新食品标准局.au/11、澳大利亚农渔林业部.au/12、美国动植物检疫局/13、新西兰生物安全局/14、美国农业部/wps/portal/usda/usdahome15、美国海关边境保护局/xp/cgov/home.xml16、美国食品药品管理局/17、新西兰食品安全局./18、北美植物保护组织的植物检疫警告系统/main.cfm19、爱尔兰食品安全局http://www.fsai.ie/20、香港贸发网/sc/21、欧洲食品安全局http://www.efsa.europa.eu/22、美国消费品安全委员会/23、美国食品安全检验局/Home/index.asp 24、美国合众国际社/25、澳大利亚产品安全局.au/26、国外网站大全/index.html27、日本厚生劳动省http://www.mhlw.go.jp/english/。
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各国药监局网站U.S.:Food and Drug Administration(美国:食品和药品管理局)UK: Medicines and Healthcare Products Regulatory Agency(英国:药物和保健产品监管署)/home.htmUK: Medical Devices Agency(英国:医疗器械署)Ukraine: Ministry of Health(乌克兰:卫生部).uaSweden: Medical Products Agency(瑞典:药品署)http://www.mpa.seSpain: Spanish Drug Agency(西班牙:西班牙药物署)http://www.msc.es/agemed/main.htmIndia: Agricultural and Processed Food Products Export Development Authority(印度:农产和加工食品出口发展局)India: Ministry of Health and Family Welfare(印度:卫生和家庭福利部)http://www.mohfw.nic.inIndia: Ministry of Food Processing Industries(印度:食品加工产业部)http://www.mofpi.nic.inIndia: Ministry of Consumer Affairs, Food & Public Distribution(印度:消费者事务、食品和公共分配部)http://www.fcamin.nic.inUK: National Institute for Biological Standards and Control(英国:国家生物学标准和管制所)UK: Department of Health(英国:卫生部)Turkey: Ministry of Health(土耳其:卫生部).trSwitzerland: Federal Veterinary Office(瑞士:联邦兽医办公室)http://www.bvet.admin.ch/0_navigation-e/0_index.htmlSwitzerland: Agency for Therapeutic Products(瑞士:治疗产品署)http://www.swissmedic.chSwitzerland: Federal Office of Public Health(瑞士:联邦公共卫生办公室)http://www.bag.admin.ch/e/index.htmSweden: National Board of Health and Welfare(瑞典:国家卫生与福利委员会)http://www.sos.se/sosmenye.htmSpain: Ministry of Health and Consumption(西班牙:卫生与消费部)http://www.msc.esSlovenia: Institute of Public Health(斯洛文尼亚:公共卫生所)http://www.sigov.si/ivz/indexang.htmlSlovenia: Ministry of Public Health(斯洛文尼亚:公共卫生部).si/mz/mz-spiet.nsfSlovak Republic: State Institute for Drug Control(斯洛伐克共和国:国家药物管制所)http://www.sukl.sk/sukl_en.htmSan Marino: Ministry of Health and Social Security(圣马力诺:卫生与社会保障部)http://www.sanita.segreteria.smUK: Food Standards Agency(英国:食品标准署)UK: Veterinary Medicines Directorate(英国:兽药理事会)Papua New Guinea: Department of Health(巴布亚新几内亚:卫生部).pgPhilippines: Department of Health(菲律宾:卫生部).phPhilippines: National Food Authority(菲律宾:国家食品局).phSingapore: Ministry of Health(新加坡:卫生部).sg/mohSingapore: Health Sciences Authority(新加坡:卫生科学局).sgSingapore: Ministry of Environment(food control)(新加坡:环境部[食品管制]).sgSingapore: Agri-food and Veterinary Authority(新加坡:农产食品和兽医局).sg/JAVASCRIPT/main-ie.htmlSri Lanka: Ministry of Health ,Nutrition & Welfare(斯里兰卡:卫生、营养和福利部).lkThailand: Ministry of Public Health(泰国:公共卫生部)http://www.moph.go.thThailand: Food and Drug Administration(泰国:食品药品管理局)http://www.fda.moph.go.th/fdaindex.htmNew Zealand: Medicines and Medical Devices Safety Authority(新西兰: 药物和医疗器械安全局)New Zealand: Ministry of Health(新西兰:卫生部)/moh.nsfKorea: Food and Drug Administration(韩国:食品药品管理局)http://www.kfda.go.krMalaysia: National Pharmaceutical Control Bureau(马来西亚:国家药品管制局).myJapan: Pharmaceuticals and Medical Devices Evaluation Center(日本:药品和医疗器械评价中心)http://www.nihs.go.jp/pmdec/outline.htmIndonesia: Ministry of Health(印尼:卫生部)http://www.depkes.go.idRussian Federation: Ministry of Public Health(俄罗斯:公共卫生部)http://www.mzsrrf.ruRomania: Ministry of Health and the Family(in Romanian)(罗马尼亚:卫生与家庭部)http://www.ms.roPortugal: Ministry of Health(葡萄牙:卫生部)http://www.min-saude.ptPoland: Drug Institute(波兰:药物所)http://www.il.waw.pl/eng.htmPoland: Ministry of Health and Social Security(波兰:卫生与社会保障部).plNorway: Norwegian Medicines Agency(挪威:挪威药物署)http://www.legemiddelverket.noNorway: Norwegian Board of Health(挪威:挪威卫生委员会)http://www.helsetilsynet.no/english.htmNorway: Ministry of Health and Social Affairs(挪威:卫生与社会事务部)http://www.odin.dep.no/shd/engelskNetherlands: Inspectorate for Health Protection and Veterinary Public Health(荷兰:健康保护和兽医公共卫生检查处)http://www.keuringsdienstvanwaren.nl/return-engels.htmlNetherlands: Medicines Evaluation Board(荷兰:药物评价委员会)http://www.cbg-meb.nlNetherlands: Ministry of Health, Welfare and Sport(荷兰:卫生、福利与体育部)http://www.minvws.nl/english/index.htmlMalta: Ministry of Health(马耳他:卫生部).mtLuxembourg: Ministry of Health(卢森堡:卫生部)http://www.etat.lu/MSLithuania: State Medicines Control Agency(立陶宛:国家药物管制署)http://www.vvkt.lt/ENG/default.htmLithuania: Ministry of Health(立陶宛:卫生部)http://www.sam.lt/index_en.htmlLatvia: State Agency of Medicines(拉脱维亚:国家药物署)http:// .lvItaly: National Institute of Health(意大利:国家卫生所)http://www.iss.itItaly: Ministry of Health(意大利:卫生部)http://www.ministerosalute.itIreland: Medicines Board(爱尔兰:药物委员会)http://www.imb.ieIreland: Department of Health and Children(爱尔兰:卫生与儿童部)http://www.doh.ieIceland: Environmental and Food Agency(冰岛:环境与食品署)http://www.hollver.is/english/emain.htmlIceland: Medicines Control Agency(冰岛:药物管制署)http://www.lyfjastofnun.is/page/enskaHungary: National Institute of Pharmacy(匈牙利:国家药房所)http://www.ogyi.hu/index.php?lang=enHungary: Ministry of Health, Social and Family Affairs(匈牙利:卫生、社会与家庭事务部)http://www.eum.hu/eum/index.htmlGreece: Hellenic Food Authority(希腊:希腊食品局)http://www.efpolis.grGreece: National Organization for Medicines(希腊:国家药物组织)http://www.eof.gr/Welcome3_en.htmGreece: Ministry of Health and Welfare(希腊:卫生与福利部)http://www.ypyp.grGermany: Federal Institute for Drugs and Medical Devices(德国:联邦药物与医疗器械所)http://www.bfarm.de/de/gb_ver/index.htmlGermany: Ministry of Health(德国:卫生部)http://www.bmgesundheit.deGeorgia: Ministry of Labor, Health and Social Security(格鲁吉亚:劳动、卫生和社会保障部)http://www.parliament.ge/gov/ministries/healthcare.htmlFrance: National Agency for Veterinary Medicinal Products(法国:国家兽用药品署)http://www.anmv.afssa.fr/en_anmvFrance: General Directorate of Competition, Consumption and Repression of Fraud(food control)(法国:竞争、消费和抑制欺诈总理事会[食品管制])http://www.finances.gouv.fr/DGCCRFFrance: Sanitary Safety of Health Products Agency(法国:健康产品卫生安全署)http://agmed.sante.gouv.frFrance: Ministry of Health(法国:卫生部)http://www.sante.gouv.frFinland: National Food Agency(芬兰:国家食品署)http:// www.nfa.fi/english/index.htmlFinland: National Agency for Medicines(芬兰:国家药物署)http://www.nam.fi/english/index.htmlFinland: Ministry of Social Affairs and Health(芬兰:社会事务和卫生部)http://www.vn.fi/stm/english/index.htmDenmark: Veterinary and Food Administration(丹麦:兽医和食品管理局).foedevaredirektoratet.dk/forside.htmEstonia: State Agency of Medicines(爱沙尼亚:国家药物署)http://www.sam.eeDenmark: Medicines Agency(丹麦:药物署)egemiddelstyrelsen.dk/index_en.htmDenmark: Ministry of Health(丹麦:卫生部)http://www.im.dk/Index/mainstart.asp?o=1&n=3&s=4Czech Republic: State Institute for Drug Control(捷克共和国:国家药物管制所)http://www.sukl.czCzech Republic: Ministry of Health(捷克共和国:卫生部)http://www.mzcr.czCroatia: Ministry of Health(克罗地亚:卫生部)http://www.tel.hr/mzrh/e-index.htmBulgaria: Drug Agency(保加利亚:药物署)http://www.bda.bgBulgaria: Ministry of Health(保加利亚:卫生部)ernment.bgBelgium: Federal Agency for the Safety of the Food Chain(比利时:联邦食物链安全署)http://www.afsca.be/indexEN.htmBelgium: Pharmaceutical Inspectorate(比利时:药品检查处)http://www.afigp.fgov.beAustria: Secretariat of Health(奥地利:卫生秘书处)http://www.bmsg.gv.at/bmsg/relaunch/gesundheit/welcome.htmArmenia: Drug and Medical Technology Agency(亚美尼亚:药物和医学技术署)http://www.pharm.amArmenia: Ministry of Health(亚美尼亚:卫生部)http://www.armhealth.amAndorra: Ministry of Health and Welfare (安道尔:卫生与福利部)http://www.salutibenestar.ad/index2.htmEuropean Commission: DG Fisheries(欧洲委员会:DG渔业)http://www.europa.eu.int/comm/dgs/fisheriesEuropean Commission: DG Agriculture(欧洲委员会:DG农业)http://www.europa.eu.int/comm/dgs/agriculture/index_en.htmEuropean Commission: DG Enterprise: Pharmaceuticals and Cosmetics(欧洲委员会:DG企业:药品和化妆品)European Commission: DG Enterprise(欧洲委员会:DG企业)http://www.europa.eu.int/comm/enterpriseEuropean Agency for the Evaluation of Medicinal Products(欧洲药品评价署)http://www.emea.eu.intUnited Arab Emirates: Federal Department of Pharmacies(阿拉伯联合酋长国:联邦药房部).ae/moh/pharmbod.htmUnited Arab Emirates: Ministry of Health(阿拉伯联合酋长国:卫生部).ae/introSaudi Arabia: Ministry of Health(沙特阿拉伯:卫生部)/main/c6h.htmPalestinian Authority: Ministry of Health(巴勒斯坦:卫生部)/mohLebanon: Ministry of Health(黎巴嫩:卫生部)/main/c6h.htmJordan: Ministry of Health(约旦:卫生部).joIsrael: Ministry of Health(以色列:卫生部).il/english.htmZimbabwe: Ministry of Health and Child Welfare(津巴布韦:卫生与儿童福利部).zw/health.htmlUganda: Ministry of Health(乌干达:卫生部)http://www.health.go.ugTunisia: Office of Pharmacy and Medicines(突尼斯:药房与药物办公室)http:// www.dpm.tnTunisia: Ministry of Public Health(突尼斯:公共卫生部)http://www.ministeres.tn/html/ministeres/sante.htmlSwaziland: Ministry of Health and Social Welfare(斯威士兰:卫生与社会福利部)/government/ministries/min-health.htmlSouth Africa: Department of Health(南非:卫生部)http://196.36.153.56/dohMorocco: Ministry of Public Health(摩洛哥:公共卫生部).maMauritius: Ministry of Health & Quality of Life(毛里求斯:卫生和生活质量部).muKenya: Ministry of Health(肯尼亚:卫生部)/government/ministries/health.htmlBotswana: Ministry of Health(博茨瓦纳:卫生部).bw/government/ministry_of_health.htmlBenin: Ministry of Health(贝宁:卫生部).bf/republic/fgouvernement.htmVenezuela: Ministry of Health and Social Development(委内瑞拉:卫生与社会发展部).veU.S.:Substance Abuse Prevention, Addictions Treatment and Mental Health Services(美国:药物滥用防止、毒瘾治疗与精神卫生局)U.S.:National Institutes of Health(美国:国家健康研究所)U.S.:National Agricultural Library USDA/FDA Foodborne Illness Education Information Center (美国:国家农业图书馆的USDA/FDA食源性疾病教育信息中心)/foodborneJoint Institute for Food Safety and Applied Nutrition(食品安全和应用营养联合研究所)National Center for Toxicological Research(国家毒理学研究中心)/nctrCenter for Veterinary Medicine(兽药中心)/cvmCenter for Food Safety and Applied Nutrition(食品安全和应用营养中心)Center for Drug Evaluation and Research(药品评价和研究中心)/cderCenter for Devices and Radiological Health(器械和辐射健康中心)/cdrhCenter for Biologics Evaluation and Research(生物制品评价和研究中心)/cberU.S.:Drug Enforcement Administration(美国:毒品强制执法管理局)/deaU.S.:Department of Health and Human Services(美国:健康和人类服务部)U.S.:Centers for Disease Control and Prevention 美国:疾病控制与预防中心Uruguay: Ministry of Public Health(乌拉圭:公共卫生部)http://www.msp.gub.uyTrinidad & Tobago: Bureau of Standards(特立尼达和多巴共和国:标准局).ttTrinidad and Tobago: Ministry of Health(特立尼达和多巴共和国:卫生部).ttPeru: General Directorate of Pharmaceuticals, Devices and Drugs(秘鲁:药品,器械与药物理事会)http://www.minsa.gob.pe/digemidPeru: Ministry of Health(秘鲁:卫生部)http://www.minsa.gob.pe/index2.htmPanama: Ministry of Health(巴拿马:卫生部)http://www.minsa.gob.paNicaragua: Ministry of Health(尼加拉瓜:卫生部)http://www.minsa.gob.niNetherlands Antilles: Department of Public Health and Environmental Protection(荷兰安的列斯群岛:公共卫生与环境保护部)http://www.mina.vomil.anJamaica: Ministry of Health(牙买加:卫生部).jmGuyana: National Bureau of Standards(圭亚那:国家标准局).gyGuyana: Ministry of Health(圭亚那:卫生部).gy/mohGuatemala: Ministry of Health(危地马拉:卫生部)http://www.mspas.gob.gtEl Salvador: Ministry of Public Health and Social Assistance(萨尔瓦多:公共卫生与社会援助部)http://www.mspas.gob.sv/mspas.htmEcuador: Ministry of Public Health(厄瓜多尔:公共卫生部).ecColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos(哥伦比亚:INVIMA国家药物和营养警戒所).coColombia: Ministry of Health(哥伦比亚:卫生部).co/NewSite/MseContent/home.aspBrazil: National Health Surveillance Agency(巴西:国家卫生监督署).brBrazil: Ministry of Health(巴西:卫生部).brBolivia: Ministry of Health and Social Welfare(玻利维亚:卫生与社会福利部).boBelize: Ministry of Health(洪都拉斯:卫生部).bz/cabinet/s-baeza/welcome.shtmlArgentina: Ministry of Health(阿根廷:卫生部).ar/htm/default.aspArgentina: National Administration of Drugs, Foods and Medical Technology(阿根廷:国家药物、食品与医疗技术管理局).ar/principal.html美国疾病控制中心/。