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) http://www.fda.gov
Europe		European Union Drug Regulatory Agency (Eudra) http://dg3.eudra.org
		EMEA http://www.emea.eu.int
		Heads of Agencies for the European Union http://heads.medagencies.org
UK		Medicines and Healthcare products Regulatory Agency (MHRA) http://www.mhra.gov.uk
Germany		BfArM http://heads.medagencies.org/germany.html
Portugal		Instituto Nacional da Farmácia e do Medicamento http://www.infarmed.pt/index2.html
France		French Health Products Safety Agency http://agmed.sante.gouv.fr
Spain		Agencia Española del Medicamento http://www.msc.es/agemed
Belgium		http://www.afigp.fgov.be
Norway		Norway Medicines Board http://www.legemiddelverket.no
Sweden		Medical Products Agency http://www.mpa.se/eng/index.shtml
Finland		National Agency for Medicines http://www.nam.fi/english/index.html
Italy		Ministero della Salute http://www.ministerosalute.it/medicinali
Netherlands		CBG http://www.cbg-meb.nl
Australia		Therapeutic Goods Administration (TGA) http://www.tga.gov.au
Bulgaria		Bulgarian Drug Agency http://www.bda.bg/web_engl/main.htm
Canada		Therapeutic Products Directorate (TPD) http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng
Chile		Chile Regulatory Agency http://www.minsal.cl
Russia		Czech Republic http://www.sukl.cz/enindex.htm
Denmark		The Danish Medicines Agency http://www.laegemiddelstyrelsen.dk/index_en.htm
Estonia		State Agency of Medicines http://www.sam.ee
Greece		EOD http://www.eof.gr
Hong Kong		Hong Kong Department of Health Welfare and Food http://www.fwfb.gov.hk/eindex.html
India		Ministry of health and family welfare http://mohfw.nic.in
Ireland		Irish Medicine Board http://www.imb.ie
Japan		Ministry of Health, Labour and Welfare (MHLW) http://www.mhlw.go.jp/english
Russia		Ministry of Health of the Russian Federation http://www.minsalud.gov.com
Switzerland		Swiss Medic http://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.html

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

International Standards Organization

International Standards Organization
www.iso.org

Medical Industry Associations

Parenteral Drug Association (PDA)
http://www.pda.org/

Institute of Validation Technology (IVT)
http://www.ivthome.com/

American Society of Quality (ASQ)
http://www.asq.org/

Intl. Society for Pharmaceutical Engineers (ISPE)
http://www.ispe.org/

Pharmaceutical Research & Manufacturers of America (PHRMA)
http://www.phrma.org/

Regulatory Affairs Professionals (RAPS)
http://www.raps.org/

Drug Information Association (DIA)
diahome.org

American Association of Pharmaceutical Scientists (AAPS)
http://www.aaps.org/

Food & Drug Law Institute (FDLI)
http://www.fdli.org/

Biotechnology Industry Association
http://www.bio.org/

Medical Device Manufacturers Association (MDMA)
http://www.medicaldevices.org/

Health Industry Manufacturers Association (HIMA)
http://www.himanet.com/

Industry Publications & Publishers

MedMarket
http://www.medmarket.com/

Advanstar  (Pharmaceutical Executive & Pharmaceutical Technology Magazines)
http://www.advanstar.com/

Biopharm Magazine
http://www.biopharm-mag.com/

F-D-C Reports (Green, Pink, Gold etc. Sheets)
http://www.fdcreports.com/

Washington Information Source Company (Warning Letter Bulletin)
http://www.fdainfo.com/

Medical Device Link (MDDI magazine)
http://www.devicelink.com/