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【收藏】各國藥監局全稱及官網一覽

來源:醫療器械注冊代辦 發布日期:2024-05-24 閱讀量:

【收藏】各國藥監局全稱及官網一覽(圖1)

U.S.:Food and Drug Administration(美國:食品和藥品管理局)

http://www.fda.gov

https://mri.cts-mrp.eu/Human/ 歐盟HMA

https://www.ema.europa.eu/en 歐盟藥監局官網

UK: Medicines and Healthcare Products Regulatory Agency(英國:藥物和保健產品監管署)

http://www.mca.gov.uk/home.htm

英國平行進口批準的藥品網站查詢:

https://www.gov.uk/government/collections/parallel-import-licences-lists-of-approved-products

http://www.pmda.go.jp/PmdaSearch/iyakuSearch/ 日本藥監局

http://www.nihs.go.jp/drug/ecqaged/bluebook/list_k.html#s 日本藍皮書

https://www.mhlw.go.jp/topics/2018/04/tp20180401-01.html日本厚生勞動省價格目錄(薬価基準収載品目リスト及び後発醫薬品に関する情報について)

https://nedrug.mfds.go.kr/index 韓國藥監局

UK: Medical Devices Agency(英國:醫療器械署)

http://www.medical-devices.gov.uk

Ukraine: Ministry of Health(烏克蘭:衛生部)

http://www.health.gov.ua

Sweden: Medical Products Agency(瑞典:藥品署)

http://www.mpa.se

Spain: Spanish Drug Agency(西班牙:西班牙藥物署)

http://www.msc.es/agemed/main.htm

India: Agricultural and Processed Food Products Export Development Authority(印度:農產和加工食品出口發展局)

http://www.apeda.com

India: Ministry of Health and Family Welfare(印度:衛生和家庭福利部)

http://www.mohfw.nic.in

India: Ministry of Food Processing Industries(印度:食品加工產業部)

http://www.mofpi.nic.in

India: Ministry of Consumer Affairs, Food & Public Distribution(印度:消費者事務、食品和公共分配部)

http://www.fcamin.nic.in

UK: National Institute for Biological Standards and Control(英國:國家生物學標準和管制所)

http://www.nibsc.ac.uk

UK: Department of Health(英國:衛生部)

http://www.doh.gov.uk

Turkey: Ministry of Health(土耳其:衛生部)

http://www.saglik.gov.tr

Switzerland: Federal Veterinary Office(瑞士:聯邦獸醫辦公室)

http://www.bvet.admin.ch/0_navigation-e/0_index.html

Switzerland: Agency for Therapeutic Products(瑞士:治療產品署)

http://www.swissmedic.ch

Switzerland: Federal Office of Public Health(瑞士:聯邦公共衛生辦公室)

http://www.bag.admin.ch/e/index.htm

Sweden: National Board of Health and Welfare(瑞典:國家衛生與福利委員會)

http://www.sos.se/sosmenye.htm

Spain: Ministry of Health and Consumption(西班牙:衛生與消費部)

http://www.msc.es

Slovenia: Institute of Public Health(斯洛文尼亞:公共衛生所)

http://www.sigov.si/ivz/indexang.html

Slovenia: Ministry of Public Health(斯洛文尼亞:公共衛生部)

http://www2.gov.si/mz/mz-spiet.nsf

Slovak Republic: State Institute for Drug Control(斯洛伐克共和國:國家藥物管制所)

http://www.sukl.sk/sukl_en.htm

San Marino: Ministry of Health and Social Security(圣馬力諾:衛生與社會保障部)

http://www.sanita.segreteria.sm

UK: Food Standards Agency(英國:食品標準署)

http://www.food.gov.uk

UK: Veterinary Medicines Directorate(英國:獸藥理事會)

http://www.vmd.gov.uk

Papua New Guinea: Department of Health(巴布亞新幾內亞:衛生部)

http://www.health.gov.pg

Philippines: Department of Health(菲律賓:衛生部)

http://www.doh.gov.ph

Philippines: National Food Authority(菲律賓:國家食品局)

http://www.nfa.gov.ph

Singapore: Ministry of Health(新加坡:衛生部)

http://www.gov.sg/moh

Singapore: Health Sciences Authority(新加坡:衛生科學局)

http://www.hsa.gov.sg

Singapore: Ministry of Environment(food control)(新加坡:環境部[食品管制])

http://www.env.gov.sg

Singapore: Agri-food and Veterinary Authority(新加坡:農產食品和獸醫局)

http://www.ava.gov.sg/JAVASCRIPT/main-ie.html

Sri Lanka: Ministry of Health ,Nutrition & Welfare(斯里蘭卡:衛生、營養和福利部)

http://www.health.gov.lk

Thailand: Ministry of Public Health(泰國:公共衛生部)

http://www.moph.go.th

Thailand: Food and Drug Administration(泰國:食品藥品管理局)

http://www.fda.moph.go.th/fdaindex.htm

New Zealand: Medicines and Medical Devices Safety Authority(新西蘭: 藥物和醫療器械安全局)

http://www.medsafe.govt.nz

New Zealand: Ministry of Health(新西蘭:衛生部)

http://www.moh.govt.nz/moh.nsf

Korea: Food and Drug Administration(韓國:食品藥品管理局)

http://www.kfda.go.kr

Malaysia: National Pharmaceutical Control Bureau(馬來西亞:國家藥品管制局)

http://www.bpfk.gov.my

Japan: Pharmaceuticals and Medical Devices Evaluation Center(日本:藥品和醫療器械評價中心)

http://www.nihs.go.jp/pmdec/outline.htm

Indonesia: Ministry of Health(印尼:衛生部)

http://www.depkes.go.id

Russian Federation: Ministry of Public Health(俄羅斯:公共衛生部)

http://www.mzsrrf.ru

Romania: Ministry of Health and the Family(in Romanian)(羅馬尼亞:衛生與家庭部)

http://www.ms.ro

Portugal: Ministry of Health(葡萄牙:衛生部)

http://www.min-saude.pt

Poland: Drug Institute(波蘭:藥物所)

http://www.il.waw.pl/eng.htm

Poland: Ministry of Health and Social Security(波蘭:衛生與社會保障部)

http://www.mzios.gov.pl

Norway: Norwegian Medicines Agency(挪威:挪威藥物署)

http://www.legemiddelverket.no

Norway: Norwegian Board of Health(挪威:挪威衛生委員會)

http://www.helsetilsynet.no/english.htm

Norway: Ministry of Health and Social Affairs(挪威:衛生與社會事務部)

http://www.odin.dep.no/shd/engelsk

Netherlands: Inspectorate for Health Protection and Veterinary Public Health(荷蘭:健康保護和獸醫公共衛生檢查處)

http://www.keuringsdienstvanwaren.nl/return-engels.html

Netherlands: Medicines Evaluation Board(荷蘭:藥物評價委員會)

http://www.cbg-meb.nl

Netherlands: Ministry of Health, Welfare and Sport(荷蘭:衛生、福利與體育部)

http://www.minvws.nl/english/index.html

Malta: Ministry of Health(馬耳他:衛生部)

http://www.health.gov.mt

Luxembourg: Ministry of Health(盧森堡:衛生部)

http://www.etat.lu/MS

Lithuania: State Medicines Control Agency(立陶宛:國家藥物管制署)

http://www.vvkt.lt/ENG/default.htm

Lithuania: Ministry of Health(立陶宛:衛生部)

http://www.sam.lt/index_en.html

Latvia: State Agency of Medicines(拉脫維亞:國家藥物署)

http:// http://www.vza.gov.lv

Italy: National Institute of Health(意大利:國家衛生所)

http://www.iss.it

Italy: Ministry of Health(意大利:衛生部)

http://www.ministerosalute.it

Ireland: Medicines Board(愛爾蘭:藥物委員會)

http://www.imb.ie

Ireland: Department of Health and Children(愛爾蘭:衛生與兒童部)

http://www.doh.ie

Iceland: Environmental and Food Agency(冰島:環境與食品署)

http://www.hollver.is/english/emain.html

Iceland: Medicines Control Agency(冰島:藥物管制署)

http://www.lyfjastofnun.is/page/enska

Hungary: National Institute of Pharmacy(匈牙利:國家藥房所)

http://www.ogyi.hu/index.php?lang=en

Hungary: Ministry of Health, Social and Family Affairs(匈牙利:衛生、社會與家庭事務部)

http://www.eum.hu/eum/index.html

Greece: Hellenic Food Authority(希臘:希臘食品局)

http://www.efpolis.gr

Greece: National Organization for Medicines(希臘:國家藥物組織)

http://www.eof.gr/Welcome3_en.htm

Greece: Ministry of Health and Welfare(希臘:衛生與福利部)

http://www.ypyp.gr

Germany: Federal Institute for Drugs and Medical Devices(德國:聯邦藥物與醫療器械所)

http://www.bfarm.de/de/gb_ver/index.html

Germany: Ministry of Health(德國:衛生部)

http://www.bmgesundheit.de

Georgia: Ministry of Labor, Health and Social Security(格魯吉亞:勞動、衛生和社會保障部)

http://www.parliament.ge/gov/ministries/healthcare.html

France: National Agency for Veterinary Medicinal Products(法國:國家獸用藥品署)

http://www.anmv.afssa.fr/en_anmv

France: General Directorate of Competition, Consumption and Repression of Fraud(food control)(法國:競爭、消費和抑制欺詐總理事會[食品管制])

http://www.finances.gouv.fr/DGCCRF

France: Sanitary Safety of Health Products Agency(法國:健康產品衛生安全署)

http://agmed.sante.gouv.fr

France: Ministry of Health(法國:衛生部)

http://www.sante.gouv.fr

Finland: National Food Agency(芬蘭:國家食品署)

http:// www.nfa.fi/english/index.html

Finland: National Agency for Medicines(芬蘭:國家藥物署)

http://www.nam.fi/english/index.html

Finland: Ministry of Social Affairs and Health(芬蘭:社會事務和衛生部)

http://www.vn.fi/stm/english/index.htm

Denmark: Veterinary and Food Administration(丹麥:獸醫和食品管理局)

http://www.uk.foedevaredirektoratet.dk/forside.htm

Estonia: State Agency of Medicines(愛沙尼亞:國家藥物署)

http://www.sam.ee

Denmark: Medicines Agency(丹麥:藥物署)

http://www.laegemiddelstyrelsen.dk/index_en.htm

Denmark: Ministry of Health(丹麥:衛生部)

http://www.im.dk/Index/mainstart.asp?o=1&n=3&s=4

Czech Republic: State Institute for Drug Control(捷克共和國:國家藥物管制所)

http://www.sukl.cz

Czech Republic: Ministry of Health(捷克共和國:衛生部)

http://www.mzcr.cz

Croatia: Ministry of Health(克羅地亞:衛生部)

http://www.tel.hr/mzrh/e-index.htm

Bulgaria: Drug Agency(保加利亞:藥物署)

http://www.bda.bg

Bulgaria: Ministry of Health(保加利亞:衛生部)

http://www.mh.government.bg

Belgium: Federal Agency for the Safety of the Food Chain(比利時:聯邦食物鏈安全署)

http://www.afsca.be/indexEN.htm

Belgium: Pharmaceutical Inspectorate(比利時:藥品檢查處)

http://www.afigp.fgov.be

Austria: Secretariat of Health(奧地利:衛生秘書處)

http://www.bmsg.gv.at/bmsg/relaunch/gesundheit/welcome.htm

Armenia: Drug and Medical Technology Agency(亞美尼亞:藥物和醫學技術署)

http://www.pharm.am

Armenia: Ministry of Health(亞美尼亞:衛生部)

http://www.armhealth.am

Andorra: Ministry of Health and Welfare (安道爾:衛生與福利部)

http://www.salutibenestar.ad/index2.htm

European Commission: DG Fisheries(歐洲委員會:DG漁業)

http://www.europa.eu.int/comm/dgs/fisheries

European Commission: DG Agriculture(歐洲委員會:DG農業)

http://www.europa.eu.int/comm/dgs/agriculture/index_en.htm

European Commission: DG Enterprise: Pharmaceuticals and Cosmetics(歐洲委員會:DG企業:藥品和化妝品)

http://pharmacos.eudra.org

European Commission: DG Enterprise(歐洲委員會:DG企業)

http://www.europa.eu.int/comm/enterprise

European Agency for the Evaluation of Medicinal Products(歐洲藥品評價署)

http://www.emea.eu.int

United Arab Emirates: Federal Department of Pharmacies(阿拉伯聯合酋長國:聯邦藥房部)

http://www.uae.gov.ae/moh/pharmbod.htm

United Arab Emirates: Ministry of Health(阿拉伯聯合酋長國:衛生部)

http://www.moh.gov.ae/intro

Saudi Arabia: Ministry of Health(沙特阿拉伯:衛生部)

http://www.saudinf.com/main/c6h.htm

Palestinian Authority: Ministry of Health(巴勒斯坦:衛生部)

http://www.pna.org/moh

Lebanon: Ministry of Health(黎巴嫩:衛生部)

http://www.saudinf.com/main/c6h.htm

Jordan: Ministry of Health(約旦:衛生部)

http://www.moh.gov.jo

Israel: Ministry of Health(以色列:衛生部)

http://www.health.gov.il/english.htm

Zimbabwe: Ministry of Health and Child Welfare(津巴布韋:衛生與兒童福利部)

http://www.gta.gov.zw/health.html

Uganda: Ministry of Health(烏干達:衛生部)

http://www.health.go.ug

Tunisia: Office of Pharmacy and Medicines(突尼斯:藥房與藥物辦公室)

http:// www.dpm.tn

Tunisia: Ministry of Public Health(突尼斯:公共衛生部)

http://www.ministeres.tn/html/ministeres/sante.html

Swaziland: Ministry of Health and Social Welfare(斯威士蘭:衛生與社會福利部)

http://www.swazi.com/government/ministries/min-health.html

South Africa: Department of Health(南非:衛生部)

http://196.36.153.56/doh

Morocco: Ministry of Public Health(摩洛哥:公共衛生部)

http://www.sante.gov.ma

Mauritius: Ministry of Health & Quality of Life(毛里求斯:衛生和生活質量部)

http://www.health.gov.mu

Kenya: Ministry of Health(肯尼亞:衛生部)

http://www.kenyaweb.com/government/ministries/health.html

Botswana: Ministry of Health(博茨瓦納:衛生部)

http://www.gov.bw/government/ministry_of_health.html

Benin: Ministry of Health(貝寧:衛生部)

http://www.primature.gov.bf/republic/fgouvernement.htm

Venezuela: Ministry of Health and Social Development(委內瑞拉:衛生與社會發展部)

http://www.platino.gov.ve

U.S.:Substance Abuse Prevention, Addictions Treatment and Mental Health Services(美國:藥物濫用防止、毒癮治療與精神衛生局)

http://www.samhsa.gov

U.S.:National Institutes of Health(美國:國家健康研究所)

http://www.nih.gov

U.S.:National Agricultural Library USDA/FDA Foodborne Illness Education Information Center(美國:國家農業圖書館的USDA/FDA食源性疾病教育信息中心)

http://www.nal.usda.gov/foodborne

Joint Institute for Food Safety and Applied Nutrition(食品安全和應用營養聯合研究所)

http://www.jifsan.umd.edu

National Center for Toxicological Research(國家毒理學研究中心)

http://www.fda.gov/nctr

Center for Veterinary Medicine(獸藥中心)

http://www.fda.gov/cvm

Center for Food Safety and Applied Nutrition(食品安全和應用營養中心)

http://vm.cfsan.fda.gov

Center for Drug Evaluation and Research(藥品評價和研究中心)

http://www.fda.gov/cder

Center for Devices and Radiological Health(器械和輻射健康中心)

http://www.fda.gov/cdrh

Center for Biologics Evaluation and Research(生物制品評價和研究中心)

http://www.fda.gov/cber

U.S.:Drug Enforcement Administration(美國:毒品強制執法管理局)

http://www.justice.gov/dea

U.S.:Department of Health and Human Services(美國:健康和人類服務部)

http://www.hhs.gov

U.S.:Centers for Disease Control and Prevention 美國:疾病控制與預防中心

http://www.cdc.gov

Uruguay: Ministry of Public Health(烏拉圭:公共衛生部)

http://www.msp.gub.uy

Trinidad & Tobago: Bureau of Standards(特立尼達和多巴共和國:標準局)

http://www.ttbs.org.tt

Trinidad and Tobago: Ministry of Health(特立尼達和多巴共和國:衛生部)

http://www.healthsectorretorreform.gov.tt

Peru: General Directorate of Pharmaceuticals, Devices and Drugs(秘魯:藥品,器械與藥物理事會)

http://www.minsa.gob.pe/digemid

Peru: Ministry of Health(秘魯:衛生部)

http://www.minsa.gob.pe/index2.htm

Panama: Ministry of Health(巴拿馬:衛生部)

http://www.minsa.gob.pa

Nicaragua: Ministry of Health(尼加拉瓜:衛生部)

http://www.minsa.gob.ni

Netherlands Antilles: Department of Public Health and Environmental Protection(荷蘭安的列斯群島:公共衛生與環境保護部)

http://www.mina.vomil.an

Jamaica: Ministry of Health(牙買加:衛生部)

http://www.moh.gov.jm

Guyana: National Bureau of Standards(圭亞那:國家標準局)

http://www.gnbs.gov.gy

Guyana: Ministry of Health(圭亞那:衛生部)

http://www.sdnp.org.gy/moh

Guatemala: Ministry of Health(危地馬拉:衛生部)

http://www.mspas.gob.gt

El Salvador: Ministry of Public Health and Social Assistance(薩爾瓦多:公共衛生與社會援助部)

http://www.mspas.gob.sv/mspas.htm

Ecuador: Ministry of Public Health(厄瓜多爾:公共衛生部)

http://www.msp.gov.ec

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos(哥倫比亞:INVIMA國家藥物和營養警戒所)

http://www.invima.gov.co

Colombia: Ministry of Health(哥倫比亞:衛生部)

http://www.minsalud.gov.co/NewSite/MseContent/home.asp

Brazil: National Health Surveillance Agency(巴西:國家衛生監督署)

http://www.anvisa.gov.br

Brazil: Ministry of Health(巴西:衛生部)

http://www.saude.gov.br

Bolivia: Ministry of Health and Social Welfare(玻利維亞:衛生與社會福利部)

http://www.sns.gov.bo

Belize: Ministry of Health(洪都拉斯:衛生部)

http://www.belize.gov.bz/cabinet/s-baeza/welcome.shtml

Argentina: Ministry of Health(阿根廷:衛生部)

http://www.msal.gov.ar/htm/default.asp

Argentina: National Administration of Drugs, Foods and Medical Technology(阿根廷:國家藥物、食品與醫療技術管理局)

http://www.anmat.gov.ar/principal.html

美國疾病控制中心

http://www.cdc.gov/

供稿:木霖森

U.S.:Food and Drug Administration(美國:食品和藥品管理局)

http://www.fda.gov

https://mri.cts-mrp.eu/Human/ 歐盟HMA

https://www.ema.europa.eu/en 歐盟藥監局官網

UK: Medicines and Healthcare Products Regulatory Agency(英國:藥物和保健產品監管署)

http://www.mca.gov.uk/home.htm

英國平行進口批準的藥品網站查詢:

https://www.gov.uk/government/collections/parallel-import-licences-lists-of-approved-products

http://www.pmda.go.jp/PmdaSearch/iyakuSearch/ 日本藥監局

http://www.nihs.go.jp/drug/ecqaged/bluebook/list_k.html#s 日本藍皮書

https://www.mhlw.go.jp/topics/2018/04/tp20180401-01.html日本厚生勞動省價格目錄(薬価基準収載品目リスト及び後発醫薬品に関する情報について)

https://nedrug.mfds.go.kr/index 韓國藥監局

UK: Medical Devices Agency(英國:醫療器械署)

http://www.medical-devices.gov.uk

Ukraine: Ministry of Health(烏克蘭:衛生部)

http://www.health.gov.ua

Sweden: Medical Products Agency(瑞典:藥品署)

http://www.mpa.se

Spain: Spanish Drug Agency(西班牙:西班牙藥物署)

http://www.msc.es/agemed/main.htm

India: Agricultural and Processed Food Products Export Development Authority(印度:農產和加工食品出口發展局)

http://www.apeda.com

India: Ministry of Health and Family Welfare(印度:衛生和家庭福利部)

http://www.mohfw.nic.in

India: Ministry of Food Processing Industries(印度:食品加工產業部)

http://www.mofpi.nic.in

India: Ministry of Consumer Affairs, Food & Public Distribution(印度:消費者事務、食品和公共分配部)

http://www.fcamin.nic.in

UK: National Institute for Biological Standards and Control(英國:國家生物學標準和管制所)

http://www.nibsc.ac.uk

UK: Department of Health(英國:衛生部)

http://www.doh.gov.uk

Turkey: Ministry of Health(土耳其:衛生部)

http://www.saglik.gov.tr

Switzerland: Federal Veterinary Office(瑞士:聯邦獸醫辦公室)

http://www.bvet.admin.ch/0_navigation-e/0_index.html

Switzerland: Agency for Therapeutic Products(瑞士:治療產品署)

http://www.swissmedic.ch

Switzerland: Federal Office of Public Health(瑞士:聯邦公共衛生辦公室)

http://www.bag.admin.ch/e/index.htm

Sweden: National Board of Health and Welfare(瑞典:國家衛生與福利委員會)

http://www.sos.se/sosmenye.htm

Spain: Ministry of Health and Consumption(西班牙:衛生與消費部)

http://www.msc.es

Slovenia: Institute of Public Health(斯洛文尼亞:公共衛生所)

http://www.sigov.si/ivz/indexang.html

Slovenia: Ministry of Public Health(斯洛文尼亞:公共衛生部)

http://www2.gov.si/mz/mz-spiet.nsf

Slovak Republic: State Institute for Drug Control(斯洛伐克共和國:國家藥物管制所)

http://www.sukl.sk/sukl_en.htm

San Marino: Ministry of Health and Social Security(圣馬力諾:衛生與社會保障部)

http://www.sanita.segreteria.sm

UK: Food Standards Agency(英國:食品標準署)

http://www.food.gov.uk

UK: Veterinary Medicines Directorate(英國:獸藥理事會)

http://www.vmd.gov.uk

Papua New Guinea: Department of Health(巴布亞新幾內亞:衛生部)

http://www.health.gov.pg

Philippines: Department of Health(菲律賓:衛生部)

http://www.doh.gov.ph

Philippines: National Food Authority(菲律賓:國家食品局)

http://www.nfa.gov.ph

Singapore: Ministry of Health(新加坡:衛生部)

http://www.gov.sg/moh

Singapore: Health Sciences Authority(新加坡:衛生科學局)

http://www.hsa.gov.sg

Singapore: Ministry of Environment(food control)(新加坡:環境部[食品管制])

http://www.env.gov.sg

Singapore: Agri-food and Veterinary Authority(新加坡:農產食品和獸醫局)

http://www.ava.gov.sg/JAVASCRIPT/main-ie.html

Sri Lanka: Ministry of Health ,Nutrition & Welfare(斯里蘭卡:衛生、營養和福利部)

http://www.health.gov.lk

Thailand: Ministry of Public Health(泰國:公共衛生部)

http://www.moph.go.th

Thailand: Food and Drug Administration(泰國:食品藥品管理局)

http://www.fda.moph.go.th/fdaindex.htm

New Zealand: Medicines and Medical Devices Safety Authority(新西蘭: 藥物和醫療器械安全局)

http://www.medsafe.govt.nz

New Zealand: Ministry of Health(新西蘭:衛生部)

http://www.moh.govt.nz/moh.nsf

Korea: Food and Drug Administration(韓國:食品藥品管理局)

http://www.kfda.go.kr

Malaysia: National Pharmaceutical Control Bureau(馬來西亞:國家藥品管制局)

http://www.bpfk.gov.my

Japan: Pharmaceuticals and Medical Devices Evaluation Center(日本:藥品和醫療器械評價中心)

http://www.nihs.go.jp/pmdec/outline.htm

Indonesia: Ministry of Health(印尼:衛生部)

http://www.depkes.go.id

Russian Federation: Ministry of Public Health(俄羅斯:公共衛生部)

http://www.mzsrrf.ru

Romania: Ministry of Health and the Family(in Romanian)(羅馬尼亞:衛生與家庭部)

http://www.ms.ro

Portugal: Ministry of Health(葡萄牙:衛生部)

http://www.min-saude.pt

Poland: Drug Institute(波蘭:藥物所)

http://www.il.waw.pl/eng.htm

Poland: Ministry of Health and Social Security(波蘭:衛生與社會保障部)

http://www.mzios.gov.pl

Norway: Norwegian Medicines Agency(挪威:挪威藥物署)

http://www.legemiddelverket.no

Norway: Norwegian Board of Health(挪威:挪威衛生委員會)

http://www.helsetilsynet.no/english.htm

Norway: Ministry of Health and Social Affairs(挪威:衛生與社會事務部)

http://www.odin.dep.no/shd/engelsk

Netherlands: Inspectorate for Health Protection and Veterinary Public Health(荷蘭:健康保護和獸醫公共衛生檢查處)

http://www.keuringsdienstvanwaren.nl/return-engels.html

Netherlands: Medicines Evaluation Board(荷蘭:藥物評價委員會)

http://www.cbg-meb.nl

Netherlands: Ministry of Health, Welfare and Sport(荷蘭:衛生、福利與體育部)

http://www.minvws.nl/english/index.html

Malta: Ministry of Health(馬耳他:衛生部)

http://www.health.gov.mt

Luxembourg: Ministry of Health(盧森堡:衛生部)

http://www.etat.lu/MS

Lithuania: State Medicines Control Agency(立陶宛:國家藥物管制署)

http://www.vvkt.lt/ENG/default.htm

Lithuania: Ministry of Health(立陶宛:衛生部)

http://www.sam.lt/index_en.html

Latvia: State Agency of Medicines(拉脫維亞:國家藥物署)

http:// http://www.vza.gov.lv

Italy: National Institute of Health(意大利:國家衛生所)

http://www.iss.it

Italy: Ministry of Health(意大利:衛生部)

http://www.ministerosalute.it

Ireland: Medicines Board(愛爾蘭:藥物委員會)

http://www.imb.ie

Ireland: Department of Health and Children(愛爾蘭:衛生與兒童部)

http://www.doh.ie

Iceland: Environmental and Food Agency(冰島:環境與食品署)

http://www.hollver.is/english/emain.html

Iceland: Medicines Control Agency(冰島:藥物管制署)

http://www.lyfjastofnun.is/page/enska

Hungary: National Institute of Pharmacy(匈牙利:國家藥房所)

http://www.ogyi.hu/index.php?lang=en

Hungary: Ministry of Health, Social and Family Affairs(匈牙利:衛生、社會與家庭事務部)

http://www.eum.hu/eum/index.html

Greece: Hellenic Food Authority(希臘:希臘食品局)

http://www.efpolis.gr

Greece: National Organization for Medicines(希臘:國家藥物組織)

http://www.eof.gr/Welcome3_en.htm

Greece: Ministry of Health and Welfare(希臘:衛生與福利部)

http://www.ypyp.gr

Germany: Federal Institute for Drugs and Medical Devices(德國:聯邦藥物與醫療器械所)

http://www.bfarm.de/de/gb_ver/index.html

Germany: Ministry of Health(德國:衛生部)

http://www.bmgesundheit.de

Georgia: Ministry of Labor, Health and Social Security(格魯吉亞:勞動、衛生和社會保障部)

http://www.parliament.ge/gov/ministries/healthcare.html

France: National Agency for Veterinary Medicinal Products(法國:國家獸用藥品署)

http://www.anmv.afssa.fr/en_anmv

France: General Directorate of Competition, Consumption and Repression of Fraud(food control)(法國:競爭、消費和抑制欺詐總理事會[食品管制])

http://www.finances.gouv.fr/DGCCRF

France: Sanitary Safety of Health Products Agency(法國:健康產品衛生安全署)

http://agmed.sante.gouv.fr

France: Ministry of Health(法國:衛生部)

http://www.sante.gouv.fr

Finland: National Food Agency(芬蘭:國家食品署)

http:// www.nfa.fi/english/index.html

Finland: National Agency for Medicines(芬蘭:國家藥物署)

http://www.nam.fi/english/index.html

Finland: Ministry of Social Affairs and Health(芬蘭:社會事務和衛生部)

http://www.vn.fi/stm/english/index.htm

Denmark: Veterinary and Food Administration(丹麥:獸醫和食品管理局)

http://www.uk.foedevaredirektoratet.dk/forside.htm

Estonia: State Agency of Medicines(愛沙尼亞:國家藥物署)

http://www.sam.ee

Denmark: Medicines Agency(丹麥:藥物署)

http://www.laegemiddelstyrelsen.dk/index_en.htm

Denmark: Ministry of Health(丹麥:衛生部)

http://www.im.dk/Index/mainstart.asp?o=1&n=3&s=4

Czech Republic: State Institute for Drug Control(捷克共和國:國家藥物管制所)

http://www.sukl.cz

Czech Republic: Ministry of Health(捷克共和國:衛生部)

http://www.mzcr.cz

Croatia: Ministry of Health(克羅地亞:衛生部)

http://www.tel.hr/mzrh/e-index.htm

Bulgaria: Drug Agency(保加利亞:藥物署)

http://www.bda.bg

Bulgaria: Ministry of Health(保加利亞:衛生部)

http://www.mh.government.bg

Belgium: Federal Agency for the Safety of the Food Chain(比利時:聯邦食物鏈安全署)

http://www.afsca.be/indexEN.htm

Belgium: Pharmaceutical Inspectorate(比利時:藥品檢查處)

http://www.afigp.fgov.be

Austria: Secretariat of Health(奧地利:衛生秘書處)

http://www.bmsg.gv.at/bmsg/relaunch/gesundheit/welcome.htm

Armenia: Drug and Medical Technology Agency(亞美尼亞:藥物和醫學技術署)

http://www.pharm.am

Armenia: Ministry of Health(亞美尼亞:衛生部)

http://www.armhealth.am

Andorra: Ministry of Health and Welfare (安道爾:衛生與福利部)

http://www.salutibenestar.ad/index2.htm

European Commission: DG Fisheries(歐洲委員會:DG漁業)

http://www.europa.eu.int/comm/dgs/fisheries

European Commission: DG Agriculture(歐洲委員會:DG農業)

http://www.europa.eu.int/comm/dgs/agriculture/index_en.htm

European Commission: DG Enterprise: Pharmaceuticals and Cosmetics(歐洲委員會:DG企業:藥品和化妝品)

http://pharmacos.eudra.org

European Commission: DG Enterprise(歐洲委員會:DG企業)

http://www.europa.eu.int/comm/enterprise

European Agency for the Evaluation of Medicinal Products(歐洲藥品評價署)

http://www.emea.eu.int

United Arab Emirates: Federal Department of Pharmacies(阿拉伯聯合酋長國:聯邦藥房部)

http://www.uae.gov.ae/moh/pharmbod.htm

United Arab Emirates: Ministry of Health(阿拉伯聯合酋長國:衛生部)

http://www.moh.gov.ae/intro

Saudi Arabia: Ministry of Health(沙特阿拉伯:衛生部)

http://www.saudinf.com/main/c6h.htm

Palestinian Authority: Ministry of Health(巴勒斯坦:衛生部)

http://www.pna.org/moh

Lebanon: Ministry of Health(黎巴嫩:衛生部)

http://www.saudinf.com/main/c6h.htm

Jordan: Ministry of Health(約旦:衛生部)

http://www.moh.gov.jo

Israel: Ministry of Health(以色列:衛生部)

http://www.health.gov.il/english.htm

Zimbabwe: Ministry of Health and Child Welfare(津巴布韋:衛生與兒童福利部)

http://www.gta.gov.zw/health.html

Uganda: Ministry of Health(烏干達:衛生部)

http://www.health.go.ug

Tunisia: Office of Pharmacy and Medicines(突尼斯:藥房與藥物辦公室)

http:// www.dpm.tn

Tunisia: Ministry of Public Health(突尼斯:公共衛生部)

http://www.ministeres.tn/html/ministeres/sante.html

Swaziland: Ministry of Health and Social Welfare(斯威士蘭:衛生與社會福利部)

http://www.swazi.com/government/ministries/min-health.html

South Africa: Department of Health(南非:衛生部)

http://196.36.153.56/doh

Morocco: Ministry of Public Health(摩洛哥:公共衛生部)

http://www.sante.gov.ma

Mauritius: Ministry of Health & Quality of Life(毛里求斯:衛生和生活質量部)

http://www.health.gov.mu

Kenya: Ministry of Health(肯尼亞:衛生部)

http://www.kenyaweb.com/government/ministries/health.html

Botswana: Ministry of Health(博茨瓦納:衛生部)

http://www.gov.bw/government/ministry_of_health.html

Benin: Ministry of Health(貝寧:衛生部)

http://www.primature.gov.bf/republic/fgouvernement.htm

Venezuela: Ministry of Health and Social Development(委內瑞拉:衛生與社會發展部)

http://www.platino.gov.ve

U.S.:Substance Abuse Prevention, Addictions Treatment and Mental Health Services(美國:藥物濫用防止、毒癮治療與精神衛生局)

http://www.samhsa.gov

U.S.:National Institutes of Health(美國:國家健康研究所)

http://www.nih.gov

U.S.:National Agricultural Library USDA/FDA Foodborne Illness Education Information Center(美國:國家農業圖書館的USDA/FDA食源性疾病教育信息中心)

http://www.nal.usda.gov/foodborne

Joint Institute for Food Safety and Applied Nutrition(食品安全和應用營養聯合研究所)

http://www.jifsan.umd.edu

National Center for Toxicological Research(國家毒理學研究中心)

http://www.fda.gov/nctr

Center for Veterinary Medicine(獸藥中心)

http://www.fda.gov/cvm

Center for Food Safety and Applied Nutrition(食品安全和應用營養中心)

http://vm.cfsan.fda.gov

Center for Drug Evaluation and Research(藥品評價和研究中心)

http://www.fda.gov/cder

Center for Devices and Radiological Health(器械和輻射健康中心)

http://www.fda.gov/cdrh

Center for Biologics Evaluation and Research(生物制品評價和研究中心)

http://www.fda.gov/cber

U.S.:Drug Enforcement Administration(美國:毒品強制執法管理局)

http://www.justice.gov/dea

U.S.:Department of Health and Human Services(美國:健康和人類服務部)

http://www.hhs.gov

U.S.:Centers for Disease Control and Prevention 美國:疾病控制與預防中心

http://www.cdc.gov

Uruguay: Ministry of Public Health(烏拉圭:公共衛生部)

http://www.msp.gub.uy

Trinidad & Tobago: Bureau of Standards(特立尼達和多巴共和國:標準局)

http://www.ttbs.org.tt

Trinidad and Tobago: Ministry of Health(特立尼達和多巴共和國:衛生部)

http://www.healthsectorretorreform.gov.tt

Peru: General Directorate of Pharmaceuticals, Devices and Drugs(秘魯:藥品,器械與藥物理事會)

http://www.minsa.gob.pe/digemid

Peru: Ministry of Health(秘魯:衛生部)

http://www.minsa.gob.pe/index2.htm

Panama: Ministry of Health(巴拿馬:衛生部)

http://www.minsa.gob.pa

Nicaragua: Ministry of Health(尼加拉瓜:衛生部)

http://www.minsa.gob.ni

Netherlands Antilles: Department of Public Health and Environmental Protection(荷蘭安的列斯群島:公共衛生與環境保護部)

http://www.mina.vomil.an

Jamaica: Ministry of Health(牙買加:衛生部)

http://www.moh.gov.jm

Guyana: National Bureau of Standards(圭亞那:國家標準局)

http://www.gnbs.gov.gy

Guyana: Ministry of Health(圭亞那:衛生部)

http://www.sdnp.org.gy/moh

Guatemala: Ministry of Health(危地馬拉:衛生部)

http://www.mspas.gob.gt

El Salvador: Ministry of Public Health and Social Assistance(薩爾瓦多:公共衛生與社會援助部)

http://www.mspas.gob.sv/mspas.htm

Ecuador: Ministry of Public Health(厄瓜多爾:公共衛生部)

http://www.msp.gov.ec

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos(哥倫比亞:INVIMA國家藥物和營養警戒所)

http://www.invima.gov.co

Colombia: Ministry of Health(哥倫比亞:衛生部)

http://www.minsalud.gov.co/NewSite/MseContent/home.asp

Brazil: National Health Surveillance Agency(巴西:國家衛生監督署)

http://www.anvisa.gov.br

Brazil: Ministry of Health(巴西:衛生部)

http://www.saude.gov.br

Bolivia: Ministry of Health and Social Welfare(玻利維亞:衛生與社會福利部)

http://www.sns.gov.bo

Belize: Ministry of Health(洪都拉斯:衛生部)

http://www.belize.gov.bz/cabinet/s-baeza/welcome.shtml

Argentina: Ministry of Health(阿根廷:衛生部)

http://www.msal.gov.ar/htm/default.asp

Argentina: National Administration of Drugs, Foods and Medical Technology(阿根廷:國家藥物、食品與醫療技術管理局)

http://www.anmat.gov.ar/principal.html

美國疾病控制中心

http://www.cdc.gov/

來源:全國體外診斷網 CAIVD

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2022年2月9日,國家藥監局發布了2022年修訂版《醫療器械產品技術要求編寫指導原則》,以下為新版與2014版對照表,供大家參考。

東南亞各國藥品注冊流程及申報資料要求

東南亞各國藥品注冊流程及申報資料要求

目錄1 東南亞國家簡介及藥品注冊申報資料要求介紹2 越南藥品疫苗和生物制品注冊程序及申報資料要求2.1 法規要求2.2 藥品注冊申報程序2.3 接收、審查藥品申報資料2.4 注冊登記號的頒發2.5 暫緩接收申報材料或頒發登記號2.6 撤銷登記號2.7 優先權2.8 疫苗和生物制品注冊2.8.1 注冊條件2.8.1.1 一次注冊2.8.1.2 再注冊2.8.2 注冊資料2.8.2.1 新注冊資料2.

八年

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思途CRO——醫療器械注冊臨床第三方平臺

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