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Regulators, Government Agencies and Similar

Agence du Medicament
www.afssaps.fr

Austrian Regulatory Authority
www.ages.at

CDER Freedom of Information Office Electronic Reading Room
http://www.fda.gov/RegulatoryInformation/foi/ElectronicReadingRoom/default.htm

CSM
www.open.gov.uk/mca/csmhome.htm

Dutch Regulatory Authority
www.cbg-meb.nl

EMEA Road map to 2010 - preparing the ground for the future
http://www.ema.europa.eu/htms/general/direct/roadmap/roadmapintro.htm

EMEA European Risk Management Strategy
www.ema.europa.eu/pdfs/human/phv/1362530en.pdf

Eudra
http://dg3.eudra.org

FDA
www.fda.gov

FDA The critical path to new medicinal products
www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

FDA Pharmaceutical cGMPs for the 21st century - a risk based approach
http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm 

FDA Drug Approvals List
www.fda.gov/cder/da/da.htm

FDA Guidance Documents
www.fda.gov/RegulatoryInformation/Guidances/default

FDA New Drug Approval Packages
www.fda.gov/cder/foi/nda

FDA Warning Letters
www.fda.gov/foi/warning

Heads of European Medicines Agencies
http://heads.medagencies.org/

ICH Q8,Q9 and Q10
www.ich.org

Legislation in Force
http://europa.eu.int

FDA Manual of Policies and Procedures (MaPPs) - CDER's official policies and procedures manual
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/default.htm

Medicines and Healthcare products Regulatory Agency (MHRA)
www.mhra.gov.uk

Medical Devices Agency
www.medical-devices.gov.uk

Medicines Evaluation Board
www.cbg-meb.nl

National Institutes of Health
www.nih.gov

Official Journal of European Communities
http://europa.eu.int

Title 21 Code of Federal Regulation
www.access.gpo.gov

US Dept Health and Human Sciences
www.dhhs.gov

Below is a link to a page on the FDA website which includes comparison charts for the FDA, EPA and OECD GLPs

If you click on the link above to open the page there will be a list of GLP sections in blue on the right (Scope, Definitions, Organization & Personnel, Facilities, Equipment, Facility Operations, Articles, Protocol & Conduct, Records & Reports, and Disqualification). Click on these sections to get to the FDA, EPA & OECD GLP Comparison Charts for these particular GLP sections.

www.fda.gov