Regulatory Links
One important 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
|
|
| Europe |
|
EMEA
www.emea.europa.eu
|
|
| Europe |
|
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/hpb-dgps/therapeut/htmleng
|
|
| 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 |
