International Regulatory Bodies
International Conference on Harmonisation- ICH
International Federation of Pharmaceutical Manufacturers Associations - IFPMA
Global Harmonization Task Force - GHTF
OECD's Work on Good Laboratory Practice (GLP) and Compliance Monitoring
World Health Organization - WHO
Australia's Therapeutic Goods Administration - TGA
Australian Drug Evaluation Committee - ADEC
Australian Department of Health and Ageing
Australian drugs designated as orphan drugs
Public Access to ARTG Medicines Information
Health Products and Food Branch
Therapeutic Products Directorate - TPD
European Agency for the Evaluation of Medicinal Products - EMEA
Mutual Recognition Facilitation Group - MRFG
European HoA - Heads of Agencies
European Department for the Quality of Medicines - EDQM
The National Institute of Health Sciences - NIHS
Ministry of Health, Labour and Welfare
Medicines and Medical Devices Safety Authority - MEDSAFE
New Zealand Ministry of Health
Medicines and Healthcare products Regulatory Agency - MHRA
Food and Drug Adminstration - FDA
Centre for Drug Evaluation and Research - CDER
Office of Regulatory Affairs - ORA
| 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 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
www.iso.org
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/
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/
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# |
Flags |
English |
French |
Country |
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1 |
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Belgium |
Belgique |
België - Belgique |
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2 |
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Czech Republic |
République Tchèque |
Česká Republika |
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3 |
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Denmark |
Danemark |
Danmark |
|
4 |
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Germany |
Allemagne |
Deutschland |
|
5 |
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Estonia |
Estonie |
Eesti |
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6 |
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Greece |
Grèce |
Ellas |
|
7 |
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Spain |
Espagne |
España |
|
8 |
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France |
France |
France |
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9 |
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Ireland |
Irlande |
Ireland - Eire |
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10 |
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Italy |
Italie |
Italia |
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11 |
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Cyprus |
Chypre |
Kypros - Kibris |
|
12 |
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Latvia |
Lettonie |
Latvija |
|
13 |
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Lithuania |
Lituanie |
Lietuva |
|
14 |
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Luxembourg |
Luxembourg |
Luxembourg |
|
15 |
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Hungary |
Hongrie |
Magyarország |
|
16 |
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Malta |
Malte |
Malta |
|
17 |
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Netherlands |
Pays Bas |
Nederland |
|
18 |
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Austria |
Autriche |
Österreich |
|
19 |
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Poland |
Pologne |
Polska |
|
20 |
|
Portugal |
Portugal |
Portugal |
|
21 |
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Slovenia |
Slovénie |
Slovenija |
|
22 |
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Slovakia |
Slovaquie |
Slovensko |
|
23 |
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Finland |
Finlande |
Suomi - Finland |
|
24 |
|
Sweden |
Suède |
Sverige |
|
25 |
|
United Kingdom |
Royaume Uni |
United Kingdom |
The European Union was composed of fifteen countries:
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The following ten countries joined the European Union in 2004:
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The following two countries may join the European Union in 2007:
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The other main countries in Europe are:
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These five countries are partly in Europe, partly in Asia:
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The minor countries in Europe are:
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There are six time zones in Europe. All countries are in the Central European Time zone [GMT+1] except those marked:
All European countires except those marked
advance their clocks one hour late March to late October.
Regulatory Bodies in Europe Click here