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.
Food and Drug Association (FDA) www.fda.gov
European Union Drug Regulatory Agency (Eudra) dg3.eudra.org
EMEA www.emea.europa.eu
Heads of Agencies for the European Union heads.medagencies.org
Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk
BfArM heads.medagencies.org/germany.html
Instituto Nacional da Farmácia e do Medicamento www.infarmed.pt/index2.html
French Health Products Safety Agency agmed.sante.gouv.fr
Agencia Española del Medicamento www.msc.es/agemed
http://www.afigp.fgov.be
Norway Medicines Board www.legemiddelverket.no
Medical Products Agency www.mpa.se/eng/index.shtml
National Agency for Medicines www.nam.fi/english/index.html
Ministero della Salute www.ministerosalute.it/medicinali
CBG www.cbg-meb.nl
Therapeutic Goods Administration (TGA) www.tga.gov.au
Bulgarian Drug Agency www.bda.bg/web_engl/main.htm
Therapeutic Products Directorate (TPD) www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng
Chile Regulatory Agency www.minsal.cl
Czech Republic www.sukl.cz/enindex.htm
The Danish Medicines Agency www.laegemiddelstyrelsen.dk/index_en.htm
State Agency of Medicines www.sam.ee
EOD www.eof.gr
Hong Kong Department of Health Welfare and Food www.fwfb.gov.hk/eindex.html
Ministry of health and family welfare mohfw.nic.in
Irish Medicine Board www.imb.ie
Ministry of Health, Labour and Welfare (MHLW) www.mhlw.go.jp/english
Ministry of Health of the Russian Federation www.minsalud.gov.com
FDA
FDA Home Page FDA Freedom of Information Index FDA Warning Letters FDA Recalls FDA Inspection Guides l FDA Compliance References CFR Titles U.S. Code CBER Guidelines CDER Guidelines CDRH Guidelines CDRH Documents CGMP Investigation Operations Manual FDA Medwatch (Medical Product Reporting Program) FDA Phone Book
