International Regulatory Links

The main prerequisite to work under cGMP is the right knowledge and understanding of the actual pharmaceutical regulations related to the specific sales market. This page summarizes the relevant links to regulatory agencies.

 

USA   Food and Drug Association (FDA)
www.fda.gov
 
Europe   European Union Drug Regulatory Agency (Eudra)
dg3.eudra.org
 
    EMEA
www.emea.europa.eu
 
    Heads of Agencies for the European Union
heads.medagencies.org
 
UK   Medicines and Healthcare products Regulatory Agency (MHRA)
www.mhra.gov.uk
 
Germany   BfArM
heads.medagencies.org/germany.html
 
Portugal   Instituto Nacional da Farmácia e do Medicamento
www.infarmed.pt/index2.html
 
France   French Health Products Safety Agency
agmed.sante.gouv.fr
 
Spain   Agencia Española del Medicamento
www.msc.es/agemed
 
Belgium   http://www.afigp.fgov.be
 
Norway   Norway Medicines Board
www.legemiddelverket.no
 
Sweden   Medical Products Agency
www.mpa.se/eng/index.shtml
 
Finland   National Agency for Medicines
www.nam.fi/english/index.html
 
Italy   Ministero della Salute
www.ministerosalute.it/medicinali
 
Netherlands   CBG
www.cbg-meb.nl
 
Australia   Therapeutic Goods Administration (TGA)
www.tga.gov.au
 
Bulgaria   Bulgarian Drug Agency
www.bda.bg/web_engl/main.htm
 
Canada  

Therapeutic Products Directorate (TPD)
www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php

 
Chile   Chile Regulatory Agency
www.minsal.cl
 
Russia   Czech Republic
www.sukl.cz/enindex.htm
 
Denmark   The Danish Medicines Agency
www.laegemiddelstyrelsen.dk/index_en.htm
 
Estonia   State Agency of Medicines
www.sam.ee
 
Greece   EOD
www.eof.gr
 
Hong Kong   Hong Kong Department of Health Welfare and Food
www.fwfb.gov.hk/eindex.html
 
India   Ministry of health and family welfare
mohfw.nic.in
 
Ireland   Irish Medicine Board
www.imb.ie
 
Japan   Ministry of Health, Labour and Welfare (MHLW)
www.mhlw.go.jp/english
 
Russia   Ministry of Health of the Russian Federation
www.minsalud.gov.com
 
Switzerland   Swiss Medic
www.swissmedic.ch
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