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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

FDA

FDA Home Page
www.fda.gov FDA Freedom of Information Index
www.fda.gov/foi/electrr.htm FDA Warning Letters
www.fda.gov/foi/warning.htm FDA Recalls
www.fda.gov/opacom/Enforce.html FDA Inspection Guides
http://www.fda.gov/ora/inspect.ref/iglist.html FDA Compliance References
http://www.fda.gov/ora/compliance.ref/default.htm CFR Titles
www.access.gpo.gov/nara/cfr/cfr-table-search.html U.S. Code
www.uscode.house.gov/usc.htm CBER Guidelines
http://www.fda.gov/cher/guidelines.htm CDER Guidelines
www.fda.gov/cder/guidance/index.htm CDRH Guidelines
www.fda.gov/cdrh/ggpmain.html CDRH Documents
www.fda.gov/cdrh/topindx.html CGMP
www.fda.gov/cder/dmpq/index.htm Investigation Operations Manual
www.fda.gov/ora/inspect_ref/iom/iomtc.html FDA Medwatch (Medical Product Reporting Program)
www.fda.gov/medwatch FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
directory.psc.gov/employee.htm

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