Below is a list of regulatory authorities that you should contact in matters of national approvals and drug import licences. This page is continuously developing. If you wish to correct or add to any information displayed below, please contact CRASH@Lshtm.ac.uk |
You might also find useful the WHO website listing similar institutions: http://www.who.int/medicines/information/websites/infdra.shtml |
Find a country: A B C D E F G H I K L M N P R S T U V
COUNTRY | REGULATORY AUTHORITY | WEBSITE |
Albania |
Ministry
of Health Tel:
042 34636 |
|
Argentina |
A.N.M.A.T. Tel: 0800 333 1234 |
http://www.anmat.gov.ar/ |
Australia |
TGA
- Therapeutic Goods Administration Street
address (Courier delivery only): Tel:
02 6232 8111 |
http://www.tga.gov.au/docs/html/clintrials.htm |
Austria |
Bundesministerium
für Gesundheit und Frauen Tel:
01/711 00-0 |
http://www.bmgf.gv.at/cms/site/ |
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Belgium |
Miss
Françoise Falize, Director Tel:
02 227 55 00 |
http://www.afigp.fgov.be/ |
Brazil | Ministério
da Saúde Comissão Nacional de Ética em Pesquisa - CONEP |
http://conselho.saude.gov.br/comissao/eticapesq.htm |
Bulgaria |
The
Bulgarian Drug Agency Tel:
2 943 40 46 |
http://www.bda.bg/?lang=en |
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Canada |
Health
Canada - Santé Canada Tel: 03 118980 328 |
http://www.hc-sc.gc.ca/english/ |
Chile |
Ministerio
de Salud Tel:
350 7477 |
http://www.minsal.cl/ |
China |
State
Food and Drug Administration Fax:
010 6831 0909 |
http://eng.sfda.gov.cn/eng/ |
Colombia |
Instituto
Nacional de Salud Email: ins@ins.gov.co |
http://www.ins.gov.co/ |
Costa Rica |
Ministerio
de Salud Costa Rica Tel: 223 0333 |
http://www.ministeriodesalud.go.cr/ |
Croatia | Ministarstvo
zdravstva i socijalne skrbi Ministry of Health and Social Welfare Ksaver 200a 10000 Zagreb Hrvatska Tel:
(01) 4607 555, 4677 005, |
http://www.miz.hr |
Cuba | Ministerio de Salud Publica | http://www.sld.cu/ |
Czech Republic |
Státní
ústav pro kontrolu léèiv Tel:
02 6708 1111 |
http://www.sukl.cz/ |
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Denmark |
The
Danish Medicines Agency Tel:
4488 9595 |
http://www.dkma.dk/ |
Ecuador |
Ministerio de Salud Pública del Ecuador |
http://www.msp.gov.ec/ |
Egypt | Ministry
of Health, Drug Policy and Planning Center 9 Emad El-Deen st. Cairo |
|
Estonia |
State
Agency of Medicines Statutes Tel:
7374 140 Bureau
of Clinical Trials |
http://www.sam.ee/index.aw?section=88 |
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Finland |
National
Agency for Medicines Tel:
9 473 341 |
|
France |
Agence
Française de Sécurité Sanitaire des Produits de Santé Tel
: 01 55.87.30.11 |
http://agmed.sante.gouv.fr/htm/5/repec/repec0.htm |
Georgia |
Ministry
of Health of Georgia Tel:
32 399947 |
http://www.molhsa.ge/eng/gov_divisions.php |
Germany |
Federal
Institute for Drugs and Tel:
0228 207 30 |
http://www.bfarm.de/de/index.php |
Ghana | ||
Greece |
National
Organisation for Medicines (EOF) Tel:
010 65 07 200 |
http://www.eof.gr/ |
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Honduras | ||
Hungary |
National
Institute of Pharmacy Tel:
01 8869 300 |
http://www.ogyi.hu/main_page/ |
Iceland |
Icelandic
Medicines Control Agency (IMCA) Tel:
520 2100 |
http://www.imca.is/ |
India |
Drug
Controller General Tel:
011 2301 8806 |
http://www.cdsco.nic.in |
Indonesia | Departement Kesehatan (Department of Health) | http://www.depkes.go.id/ |
Iran | ||
Ireland |
Irish
Medicines Board Tel:
01 676 4971 |
http://www.imb.ie/ |
Italy |
Agencia
Italiana del Farmaco Tel:
06 5978401 |
http://www.agenziafarmaco.it/section8983.html |
Ivory Coast | Ministere de la Sante Publique | |
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Kenya |
Ministry
of Health Tel:
02 717077 |
http://www.health.go.ke |
Latvia |
State
Agency of Medicines Tel:
707 8424, 707 8444 Clinical
Trials Department |
http://www.vza.gov.lv/ |
Lithuania |
The
State Medicines Control Agency at the Ministry of Health of Lithuania Tel:
5 263 9264 |
http://www.vvkt.lt/ |
Malaysia |
National
Pharmaceutical Control Bureau Tel:
03 7957 3611 |
|
Malta |
Medicines
Regulatory Unit Tel:
2343 9135 |
|
Mexico | Secretaría
de Salud Comisión Nacional de Investigación en Salud |
http://www.salud.gob.mx/ |
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Neatherlands | Medicines
Evaluation Board Correspondence address:* P.O. Box 16229 2500 BE Den Haag * Please send your dossiers to the Correspondence address. Visitor
address: Tel
070 356 7400 |
http://www.cbg-meb.nl/CBG/en/human-medicines/regulatory-affairs/default.htm |
New Zealand |
Medsafe Street/Courier
address: Tel:
04 496 2000 |
http://www.medsafe.govt.nz/ |
Nigeria | National
Agency for Food and Drug Administration and Control (NAFDAC) Corporate Headquarters Plot 2032 Olusegun Obasanjo Way Wuse Zone 7 Abuja Tel:
09 524 0995-6 |
http://www.nafdacnigeria.org |
Norway | Norwegian
Medicines Agency Statens legemiddelverk Sven Oftedals vei 6 0950 OSLO Tel:
022 89 77 00 |
http://www.legemiddelverket.no/templates/InterPage____16645.aspx |
Pakistan |
Drugs
Controller, Ministry of Health Tel: 828867 |
http://www.dcomoh.gov.pk/ |
Panama | Instituto Conmemorativo GORGAS de Estudios de la Salud | http://www.gorgas.gob.pa |
Paraguay | Ministerio de Salud Pública y Bienestar Social | |
Peru | Ministerio
de Salud del Peru Instituto Nacional de Salud del Perú (INS) Capac Yupanqui 1400 Jesús Maria Lima |
http://www.ins.gob.pe/ |
Portugal | Instituto
Nacional da Farmácia e do Medicamento Parque de Saúde de Lisboa Avenida do Brasil, 53 1749-004 Lisboa |
http://www.infarmed.pt |
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Romania |
National
Medicines Agency Agentia Nationala a Medicamentului Tel:
21 224.11.00 - 04 |
http://www.anm.ro/en/home.html |
Saudi Arabia |
Ministry
of Health Tel:
401 2220 / 401 2392 |
http://www.moh.gov.sa/ |
Serbia & Montenegro |
Medicines
and Medical Devices Agency of Serbia Tel:
011 246 83 22 Fax:
011 39 743 40 |
http://www.alims.sr.gov.yu/ |
Singapore |
Centre
for Pharmaceutical Administration Tel:
6325 5629 |
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials.html |
Slovakia |
STATE
INSTITUTE FOR DRUG CONTROL Tel:
2 5070 1111 |
http://www.sukl.sk/ |
South Africa | Medicines Control Council | http://www.mccza.com/ |
Spain |
Ministerio
de Sanidad y Consumo - Agencia Española del Medicamento Tel.:
915 964 171 |
http://www.agemed.es |
Sri Lanka |
Drug
Regulatory Authority |
http://www.health.gov.lk/ |
Sweden |
Medical
Products Agency Läkemedelsvärke Visiting
address: Tel:
018 174600 |
http://www.mpa.se/eng/index.shtml |
Switzerland |
Swissmedic
Tel:
031 322 0223 |
http://www.swissmedic.ch/ |
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Thailand | Ministry of Public Health | http://www.moph.go.th/ |
Tunisia |
Ministère
de la Santé publique Tel:
71 560545 |
http://www.ministeres.tn/html/indexgouv.html |
Turkey |
Ministry
of Health Tel:
312 435 6440 |
http://www.saglik.gov.tr |
Uganda |
Uganda
National Council for Science and Technology (UNCST) Tel:
41 250499 |
http://www.uncst.gov.ug |
National
Drug Authority Tel:
41 255665 / 347391/2 |
http://www.nda.or.ug/ | |
United Kingdom |
Medicine
and Healthcare Products Regulatory Agency (MHRA) Tel:
020 7084 2000 (Mon-Fri 9-5) |
http://medicines.mhra.gov.uk/ |
Ukraine |
State
Department for Quality Control, Safety and Production of Remedies and
Goods for Medical Purpose Tel:
044 444 1048 |
http://www.moz.gov.ua/ua/main/siterubr/ |
Venezuela | Ministerio de Salud y Desarrollo Social | http://www.msds.gov.ve |
Vietnam |
Drug
Administration of Vietnam Tel:
04 8462010 |
http://www.moh.gov.vn/ |
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