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/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