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
Department of Pharmacy
Tirana

Tel: 042 34636
Fax: 042 28303

Argentina

A.N.M.A.T.
Av. de Mayo 869
Capital Federal

Tel: 0800 333 1234

http://www.anmat.gov.ar/
Australia

TGA - Therapeutic Goods Administration
Postal address:
PO Box 100
Woden ACT 2606

Street address (Courier delivery only):
136 Narrabundah Lane
Symonston ACT 2609

Tel: 02 6232 8111
Fax: 02 6232 8112
Email: eds@health.gov.au

http://www.tga.gov.au/docs/html/clintrials.htm
Austria

Bundesministerium für Gesundheit und Frauen
Radetzkystrasse 2
1030 Wien

Tel: 01/711 00-0
Fax: 01/711 00-14300
Email: buergerservice@bmgf.gv.at

http://www.bmgf.gv.at/cms/site/

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Belgium

Miss Françoise Falize, Director
RAC CAE VESALIUS
Rue Montagne de l’Oratoire 20, boîte 3
B-1010 Brussels

Tel: 02 227 55 00
Fax: 02 227 55 55
Email: ct.rd@health.fgov.be

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
26, Yanko Sakazov Blvd.
1504, Sofia

Tel: 2 943 40 46
Fax: 2 943 44 87
Email: bda@bda.bg
Hot line: 2 944 16 36

http://www.bda.bg/?lang=en

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Canada

Health Canada - Santé Canada
Tunney's Pasture
OTTAWA
Ontario
K1A 0L2

Tel: 03 118980 328

http://www.hc-sc.gc.ca/english/
Chile

Ministerio de Salud
Instituto de Salud Publico de Chile
Marathón 1000
Nuñoa

Tel: 350 7477
Fax: 350 7578
Email: casilla@ispch.cl

http://www.minsal.cl/
China

State Food and Drug Administration
A38, Beilishi Road
Beijing 100810

Fax: 010 6831 0909
Email: inquires@sda.gov.cn

http://eng.sfda.gov.cn/eng/
Colombia

Instituto Nacional de Salud
Avenida Calle 26 No 51-60
Zona 6 CAN
Conmutador: 1 220 7700
Bogotá D.C.

Email: ins@ins.gov.co

http://www.ins.gov.co/
Costa Rica

Ministerio de Salud Costa Rica
Calle 6 Avenida 6y8
San José
Apartado Postal : 10123-1000 San José

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,
4677 100, 4677 093
Fax: (01) 4677 091

http://www.miz.hr
Cuba Ministerio de Salud Publica http://www.sld.cu/
Czech Republic

Státní ústav pro kontrolu léèiv
State Institute for Drug Control

Šrobárova 48
100 41 Praha 10

Tel: 02 6708 1111
Fax: 02 7173 2377
Email: sukl@sukl.cz

http://www.sukl.cz/

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Denmark

The Danish Medicines Agency
Axel Heides Gade 1
DK-2300 København S

Tel: 4488 9595
Fax: 4488 9599
Email: dkma@dkma.dk

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
19 Ravila Street
50411 Tartu

Tel: 7374 140
Fax: 7374 142
Email: sam@sam.ee

Bureau of Clinical Trials
Email: clinical.trials@sam.ee

http://www.sam.ee/index.aw?section=88

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Finland

National Agency for Medicines
Mannerheimintie 166
P.O.Box 55
00301 Helsinki

Tel: 9 473 341
Fax: 9 714 469
Email: kirjaamo@nam.fi

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

France

Agence Française de Sécurité Sanitaire des Produits de Santé
143-147, Boulevard Anatole France
93285 Saint-Denis Cedex

Tel : 01 55.87.30.11
Fax : 01 55.87.30.12

http://agmed.sante.gouv.fr/htm/5/repec/repec0.htm
Georgia

Ministry of Health of Georgia
Pharmacological Committee

29 Mitskevich st.
380060 Tbilisi

Tel: 32 399947
Fax: 32 934851
Email: pharmcom@posta.ge

http://www.molhsa.ge/eng/gov_divisions.php
Germany

Federal Institute for Drugs and
Medical Devices

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Tel: 0228 207 30
Fax: 0228 207 5207
Email: poststelle@BfArM.de

http://www.bfarm.de/de/index.php
Ghana
Greece

National Organisation for Medicines (EOF)
284, Mesogeion Av.
15562 Cholargos

Tel: 010 65 07 200
Fax : 010 65 45 535
Email: relation@eof.gr

http://www.eof.gr/

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Honduras
Hungary

National Institute of Pharmacy
Országos Gyógyszerészeti Intézet

1051 Budapest
Zrínyi u. 3
1372 Postafiók 450

Tel: 01 8869 300
Fax: 01 8869 460
Email: ogyi@ogyi.hu

http://www.ogyi.hu/main_page/
Iceland

Icelandic Medicines Control Agency (IMCA)
Eiðistorg 13-15,
P.O.Box 180
172 Seltjarnarnes

Tel: 520 2100
Fax: 561 2170
Email: imca@imca.is

http://www.imca.is/
India

Drug Controller General
Directorate General of Health Services
Nirman Bhawan
New Delhi 110 011

Tel: 011 2301 8806
Fax: 011 2301 8806
Email: dci@nb.nic.in

http://www.cdsco.nic.in
Indonesia Departement Kesehatan (Department of Health) http://www.depkes.go.id/
Iran
Ireland

Irish Medicines Board
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Tel: 01 676 4971
Fax: 01 676 7836
Email: imb@imb.ie

http://www.imb.ie/
Italy

Agencia Italiana del Farmaco
Via della Sierra Nevada
60
00144 ROMA

Tel: 06 5978401
Fax: 06 6425 1275
Email: servicedesk@almavivaitalia.it

http://www.agenziafarmaco.it/section8983.html
Ivory Coast Ministere de la Sante Publique

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Kenya

Ministry of Health
Office of the Director of Medical Services

Afya House
Cathedral Road
P.O.Box 30016
Nairobi

Tel: 02 717077
Fax: 02 715239

http://www.health.go.ke
Latvia

State Agency of Medicines
State Joint-Stock Company
15 Jersika street
Riga 1003

Tel: 707 8424, 707 8444
Fax: 707 8428
Email: info@vza.gov.lv

Clinical Trials Department
707 8433

http://www.vza.gov.lv/
Lithuania

The State Medicines Control Agency at the Ministry of Health of Lithuania
Traku str. 14
LT-01132 Vilnius

Tel: 5 263 9264
Fax: 5 263 9265
Email vvkt@vvkt.lt

http://www.vvkt.lt/
Malaysia

National Pharmaceutical Control Bureau
Ministry of Health Malaysia

Jalan University
P.O. Box 319
46730 Petaling Jaya
Malaysia

Tel: 03 7957 3611
Fax: 03 7958 1312

http://www.bpfk.gov.my/

Malta

Medicines Regulatory Unit
198, Rue D'Argens
Gzira, GZR 003

Tel: 2343 9135
Fax: 2343 9161
info.mru@gov.mt

 

http://www.sahha.gov.mt/


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:
Kalvermarkt 53
2511 CB Den Haag

Tel 070 356 7400
Fax 070 356 7515
Email: info@cbg-meb.nl

http://www.cbg-meb.nl/CBG/en/human-medicines/regulatory-affairs/default.htm
New Zealand

Medsafe
New Zealand Medicines and Medical Devices Safety Authority

P O Box 5013
Wellington

Street/Courier address:
Level 18
Grand Plimmer Tower
2-6 Gilmer Tce
Wellington

Tel: 04 496 2000
Fax: 04 496 2229

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
Fax: 09 524 0994
Email: nafdacdg@nafdacnigeria.org

http://www.nafdacnigeria.org
Norway Norwegian Medicines Agency
Statens legemiddelverk
Sven Oftedals vei 6
0950 OSLO

Tel: 022 89 77 00
Fax: 022 89 77 99
Email: post@legemiddelverket.no

http://www.legemiddelverket.no/templates/InterPage____16645.aspx
Pakistan

Drugs Controller, Ministry of Health
Islamabad

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

http://www.mspbs.gov.py/

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
Str. Aviator Sanatescu, Nr. 48
Sector 1
Bucuresti

Tel: 21 224.11.00 - 04
21 224.10.79
Fax: 21 224.34.97

http://www.anm.ro/en/home.html
Saudi Arabia

Ministry of Health
Airport Road
Riyadh 11176

Tel: 401 2220 / 401 2392
Fax: 402 9876

http://www.moh.gov.sa/
Serbia & Montenegro

Medicines and Medical Devices Agency of Serbia
458, Vojvode Stepe street
Belgrade 11152

Tel: 011 246 83 22
011 460 250
011 246 29 86
011 397 28 69
011 397 43 64

Fax: 011 39 743 40
Tel/Fax: 011 397 72 12
E-mail: hygia@alims.sr.gov.yu

http://www.alims.sr.gov.yu/
Singapore

Centre for Pharmaceutical Administration
Health Sciences Authority
Singapore
2 Jalan Bukit Merah
Singapore 169547

Tel: 6325 5629
Fax: 6224 2352

http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials.html

Slovakia

STATE INSTITUTE FOR DRUG CONTROL
Slovakia ( Statny ustav pre kontrolu lieciv, Slovensko)

Kvetná 11
825 08 Bratislava 26

Tel: 2 5070 1111
Fax: 2 5556 4127
Email: sukl@sukl.sk
Secretariat: sekretariat@sukl.sk
Registration: registracia@sukl.sk

http://www.sukl.sk/
South Africa Medicines Control Council http://www.mccza.com/
Spain

Ministerio de Sanidad y Consumo - Agencia Española del Medicamento
Paseo del Prado, 18-20
E-28014 Madrid

Tel.: 915 964 171
Fax: 915 964 074
Email: sdaem@agemed.es

http://www.agemed.es
Sri Lanka

Drug Regulatory Authority
Ministry of Health
Colombo

http://www.health.gov.lk/
Sweden

Medical Products Agency Läkemedelsvärke
Box 26
SE-751 03 Uppsala

Visiting address:
Dag Hammarskjölds väg 42
751 83 Uppsala

Tel: 018 174600
Fax : 018 548566
Email: registrator@mpa.se

http://www.mpa.se/eng/index.shtml
Switzerland

Swissmedic
Swiss Agency for Therapeutic Products Schweizerisches Heilmittelinstitut

Erlachstrasse 8
3000 Bern 9

Tel: 031 322 0223
Fax: 031 322 1112
Email: info@swissmedic.ch

http://www.swissmedic.ch/

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Thailand Ministry of Public Health http://www.moph.go.th/
Tunisia

Ministère de la Santé publique
Bab Saadoun
1006 Tunis

Tel: 71 560545
Email: msp@ministeres.tn

http://www.ministeres.tn/html/indexgouv.html
Turkey

Ministry of Health
Mithatpasa Cad. No:3
Sihhiye
Ankara

Tel: 312 435 6440
Fax: 312 433 9885
Email: info@saglik.gov.tr

http://www.saglik.gov.tr
Uganda

Uganda National Council for Science and Technology (UNCST)
Plot 10 Kampala Road
Uganda House, 11th Floor
P.O.B. 6884
Kampala

Tel: 41 250499
Fax: 41 234579
Email: uncst@starcom.co.ug

http://www.uncst.gov.ug

National Drug Authority
PO Box 23096
Kampala
Secretariat Office
Plot 46/48 Lumumba Avenue
Kampala

Tel: 41 255665 / 347391/2
Fax: 41 255758
Email: ndaug@nda.or.ug

http://www.nda.or.ug/
United Kingdom

Medicine and Healthcare Products Regulatory Agency (MHRA)
Information Centre
10-2, Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 2000 (Mon-Fri 9-5)
Tel: 020 7210 3000 (other times)
Fax: 020 7084 2353
Email: info@mhra.gsi.gov.uk

http://medicines.mhra.gov.uk/
Ukraine

State Department for Quality Control, Safety and Production of Remedies and Goods for Medical Purpose
120 Peremogy pr.
Kyiv

Tel: 044 444 1048
Email: admin@cmt.kiev.ua

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
Ministry of Health

138A Giang Vo
Hanoi
Vietnam

Tel: 04 8462010
Fax: 04 8234758

http://www.moh.gov.vn/

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