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Regulatory Links

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/

The Member States - EU

 Protocol Order of EU Member State Flags 

#

Flags

English

French

Country

1

Belgium

Belgique

België - Belgique

2

Czech Republic

République Tchèque

Česká Republika

3

Denmark

Danemark

Danmark

4

Germany

Allemagne

Deutschland

5

Estonia

Estonie

Eesti

6

Greece

Grèce

Ellas

7

Spain

Espagne

España

8

France

France

France

9

Ireland

Irlande

Ireland - Eire

10

Italy

Italie

Italia

11

Cyprus

Chypre

Kypros - Kibris

12

Latvia

Lettonie

Latvija

13

Lithuania

Lituanie

Lietuva

14

Luxembourg

Luxembourg

Luxembourg

15

Hungary

Hongrie

Magyarország

16

Malta

Malte

Malta

17

Netherlands

Pays Bas

Nederland

18

Austria

Autriche

Österreich

19

Poland

Pologne

Polska

20

Portugal

Portugal

Portugal

21

Slovenia

Slovénie

Slovenija

22

Slovakia

Slovaquie

Slovensko

23

Finland

Finlande

Suomi - Finland

24

Sweden

Suède

Sverige

25

United Kingdom

Royaume Uni

United Kingdom

European Union and other European countries

 

 The European Union was composed of fifteen countries:

European
Union
United C
Kingdom
France Germany
Italy Republic of
Ireland C
Belgium The
Netherlands
Luxembourg Sweden Denmark Finland D
Spain Portugal C Austria Greece D

The following ten countries joined the European Union in 2004:

Poland S Estonia D S Latvia D S Lithuania D
Czech
Republic
Slovakia Hungary Slovenia
Cyprus D Malta

The following two countries may join the European Union in 2007:

                   
Romania D Bulgaria D

The other main countries in Europe are:

S Iceland C Norway Switzerland Moldova D
Ukraine D Croatia Bosnia Belarus D
Yugoslavia Albania FYR
Macedonia

These five countries are partly in Europe, partly in Asia:

S Kazakhstan Y Georgia H Azerbaijan G Turkey D
Russia H

The minor countries in Europe are:

Andorra Vatican
City
Liechtenstein San Marino
Monaco

There are six time zones in Europe. All countries are in the Central European Time zone [GMT+1] except those marked:

C West European Time [GMT]
D East European Time [GMT+2]
H Moscow Time [GMT+3]
G Baku Time [GMT+4]
Y Ural Time [GMT+5]

All European countires except those marked S advance their clocks one hour late March to late October.

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Regulatory Bodies in Europe Click here