International Programs

Confidentiality Commitments

COUNTRYSUBJECTScopeLINKSCONTACTDATES
Effective - Expiration
AustraliaInformation sharingDrugs, Biologics, Medical Devices, Radiation-Emitting ProductsFDA [PDF]
TGA [PDF]
Sema D. Hashemi08/25/2014
In effect indefinitely
AustraliaInformation sharingTobaccoFDA [HTML]
DHA [HTML]
Sema D. Hashemi08/08/2012
In effect indefinitely
AustraliaInformation SharingCosmeticsFDA [HTML]
NICNAS [HTML]
Sema D. Hashemi 
 
03/8/2011
In effect indefinitely
AustraliaInformation SharingFoods, AnimalFDA [HTML]
AQIS [HTML]
Sema D. Hashemi 
 
03/17/2009
In effect indefinitely
AustraliaInformation SharingAnimal & VeterinaryFDA [HTML]
APMVA [HTML]
Sema D. Hashemi 
 
10/20/2005
In effect indefinitely
AustraliaInformation SharingDrugs, Biologics, Medical Devices, Radiation-Emitting ProductsFDA [HTML]
TGA [HTML]
Sema D. Hashemi 08/11/2004
In effect indefinitely
Australia / New ZealandInformation SharingFoodsFDA [HTML]
FSANZ [HTML]
Sema D. Hashemi 
 
04/15/2008
In effect indefinitely
AustriaInformation SharingDrugs, Medical Devices, Animal & Veterinary

FDA [HTML]

BASG [HTML]

Angela Byrod08/18/2009
In effect indefinitely
BrazilInformation SharingFoods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products

FDA
English [HTML]
Portuguese [HTML]

ANVISA
Portuguese [HTML]
English [HTML]

Bruce Ross
 
09/24/2010
In effect indefinitely
BelgiumInformation SharingFoods, Drugs, Biologics, Medical Devices[HTML]Angela Byrod12/15/2004
In effect indefinitely
BelgiumInformation SharingDrugs, Medical Devices, Animal & Veterinary[HTML]Angela Byrod 04/23/2007
In effect indefinitely
CanadaInformation SharingTobaccoFDA
English [HTML]
French [HTML]

CSTD
English [HTML]
French [HTML]
Sema D. Hashemi 1/2/2012
In effect indefinitely
CanadaInformation Sharing Biologics, Food SafetyFDA [HTML]
PHAC [HTML]
Sema D. Hashemi 
 
9/28/2011
In effect indefinitely
CanadaInformation SharingFoodsFDA [HTML]
CFIA [HTML]
Sema D. Hashemi 
 
12/22/2003
In effect indefinitely
CanadaInformation SharingFoods, Medical Devices, Animal & Veterinary Drugs, Biologics, Radiation-Emitting ProductsFDA [HTML]
HPFB of Health Canada [HTML]
Sema D. Hashemi 
 
11/18/2003
In effect indefinitely
ChileInformation SharingFoods, Drugs, Medical Device, biologics, and CosmeticsFDA
English [HTML]
Español [HTML]

ISP
Español [HTML]
English [HTML]
Edmundo Garcia 
 
03/19/2012
In effect indefinitely
Czech RepublicInformation SharingDrugs, Biologics and VaccinesFDA [HTML]
SIDC [HTML]
 
Angela Byrod 
 
09/23/2012
In effect indefinitely
DenmarkInformation sharingFoods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco productsFDA
[Pdf 2.71 MB]
DHMA
[Pdf 1.11 MB]
Angela Byrod2/24/2014
In effect indefinitely
DenmarkInformation sharingDrugs and Medical DevicesFDA [HTML]
DMA [HTML]
Angela Byrod11/14/2007
In effect indefinitely
EstoniaInformation SharingDrugs, Biologics, Animal & Veterinary Medical ProductsFDA [HTML]
EE SAM [HTML]
Angela Byrod 12/02/2013
In effect indefinitely
Europe - Council of EuropeInformation SharingDrugs, Biologics, Animal & Veterinary ProductsFDA [HTML]
EDQM [HTML]
Angela Byrod 05/04/2009
In effect indefinitely
European Union EC, DG EnterpriseInformation Sharing related to Medical DevicesN/A,
responsibilities transferred to DG SANCO
FDA [HTML]
DG-Enterprise [HTML]
Angela Byrod 07/02/2007
-
07/02/2012
European Union EC, DG EnterpriseInformation Sharing related to CosmeticsN/A,
Responsibilities transferred to DG SANCO
FDA [HTML]
DG-Enterprise [HTML]
Angela Byrod 07/02/2007
-
07/02/2012
European Union (EFSA)Information Sharing related to food and feedFoodsFDA [HTML]
EFSA [HTML]
Angela Byrod 07/02/2007
In effect indefinitely
European Union
(EMA)
Information SharingDrugs, Biologics, Animal & Veterinary Products
 
FDA [HTML]
EMA [HTML]
Angela Byrod 09/14/2003
In effect indefinitely
 
European Union
(EC, DG SANCO)
Information SharingFoods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco productsFDA [HTML]
DG-SANCO [HTML]
Angela Byrod 6/6/2005
In effect indefinitely
FranceInformation SharingFoodsFDA [HTML]
DGAL [HTML]
Angela Byrod12/03/2012
In effect indefinitely
FranceInformation SharingDrugs, Biologics, Medical Devices, CosmeticsFDA and ANSM formerly AFSSAPS [HTML]
Name Change notification Pdf [137 KB]
Angela ByrodExtended indefinitely
2/08/2006
-
2/08/2011
FranceInformation SharingFoods, Animal & VeterinaryFDA-ANSES [HTML]Angela Byrod 3/21/2011
In effect indefinitely
GermanyInformation SharingDrugs, Biologics and Animal & VeterinaryFDA [HTML]
PEI [HTML]
Angela Byrod 1/30/2006
In effect indefinitely
GermanyInformation SharingFoods and Radiation-Emitting ProductsBFUNR-FDA [HTML]Angela Byrod 02/04/2005
In effect indefinitely
GermanyInformation SharingDrugs, Medical DevicesBfArM-FDA [HTML]Angela Byrod02/02/2005
In effect indefinitely
GermanyInformation SharingFoods, Animal & Veterinary and Tobacco ProductsBVL [HTML]Angela Byrod 02/12/2010
In effect indefinitely
GermanyInformation SharingFoods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products and  Tobacco ProductsBMG [HTML]Angela Byrod01/25/2008
In effect indefinitely
IrelandInformation SharingFoodsFDA [HTML]
FSAI [HTML]
Angela Byrod2/26/2013
In effect indefinitely
IrelandInformation SharingDrugs, Biologics, Medical Devices, Animal & Veterinary, CosmeticsFDA [HTML]
IMB [HTML]
Angela Byrod9/20/2005
In effect indefinitely
IrelandInformation SharingGood laboratory practicesINAB [HTML]Angela Byrod 06/14/2005
In effect indefinitely
IsraelInformation SharingDrugs, Medical Devices, Foods, Veterinary Drugs, Cosmetics, Radiation-Emitting ProductsFDA [HTML]
The Administration [HTML]
Layla I. Batarseh 
 
12/15/2005
In effect indefinitely
ItalyInformation SharingFood, animal & veterinary, cosmetics, tobacco, IMOH-regulated medical devicesFDA 

Italian Ministry of Health (IMOH)
Angela Byrod 06/27/2014
In effect indefinitely
ItalyInformation SharingDrugsFDA [HTML
AIFA [HTML]
Angela Byrod 12/04/2009
In effect indefinitely
JapanInformation SharingAnimal Foods and feeds, Veterinary drugsFDA [HTML]
FSCAB and NVAL [HTML]
Sema D. Hashemi3/16/2012
In effect indefinitely
JapanInformation SharingBiologics, Human Drugs, and Medical DevicesFDA [HTML]
PMDA [HTML]
Sema D. Hashemi09/15/2004
In effect indefinitely
JapanInformation SharingBiologics, Cosmetics, Human Drugs, Food and Medical DevicesFDA [HTML]
PFSB[HTML]
Sema D. Hashemi09/15/2004
In effect indefinitely
MexicoInformation sharingFoods, Drugs, Medical Devices, Biologics, Cosmetics, Radiation-Emitting Products, Tobacco ProductsFDA [HTML]
Español
COFEPRIS [HTML]
Español
Bruce Ross
 
04/15/2002
In effect indefinitely
MexicoInformation sharingFoods, Animal & VeterinarySAGARPA [HTML]Bruce Ross 
 
5/7/2004
In effect indefinitely
NetherlandsInformation sharingDrugs, Biologics, Medical Devices, Animal & Veterinary, FoodsFDA [HTML]
MEB-IGZ [HTML]
Angela Byrod10/02/2006
In effect indefinitely
New ZealandInformation sharingTobacco ProductsFDA [HTML]
The Ministry [HTML]
Sema D. Hashemi 9/30/2011
In effect indefinitely
New ZealandInformation sharingFoodsFDA [HTML]
NZFSA [HTML]
Sema D. Hashemi 10/28/2004
In effect indefinitely
New ZealandInformation sharingDrugs, Biologics, Medical Devices, Radiation-Emitting ProductsMedsafe [HTML]Sema D. Hashemi 
 
03/02/2007
In effect indefinitely
PolandInformation sharingBiologics, Medical Products for Human and Veterinary Use, Medical DevicesFDA [HTML]
GIF [HTML]
Angela Byrod 
 
08/22/2013
In effect indefinitely
PolandInformation sharingBiologics, Medical Products for Human and Veterinary Use, Medical DevicesFDA [HTML]
URPLWMiPB [HTML]
Angela Byrod 
 
08/22/2013
In effect indefinitely
PortugalInformation Sharing
(Information from IPMA to FDA only; FDA employees are not authorized to share non-public information with IPMA).
SeafoodFDA [HTML]Katherine Cooper 
 
09/11/2013
In effect indefinitely
SingaporeInformation sharingBiologics, Cosmetics, Human Drugs, Medical Devices and Tobacco ProductsFDA [HTML
HSA [HTML]
Sema D. Hashemi 8/25/2004
In effect indefinitely
South AfricaInformation sharingBiologics and Human Drugs, and Veterinary ProductsFDA [HTML
MCC [HTML]
Sema D. Hashemi 
 
12/06/2004
In effect indefinitely
SpainInformation sharingDrugs, Biologics, Medical Devices, Cosmetics, Animal & Veterinary Medicines, and Radiation-Emitting ProductsFDA [HTML]
AEMPS [HTML]
Angela Byrod12/18/2013
In effect indefinitely
SpainInformation sharingFoodsFDA
English [HTML]
Español [HTML]

AESAN
English[HTML]
Español [HTML]
Angela Byrod3/7/2013
In effect indefinitely
SwedenInformation SharingDrugs, Biologics, Medical Devices, CosmeticsFDA [HTML
MPA [HTML]
Angela Byrod03/31/2006
In effect indefinitely
SwitzerlandInformation sharingDrugs, Biologics, Medical Devices, Animal & VeterinarySwissmedic [HTML]Angela Byrod9/17/2003
In effect indefinitely
SwitzerlandInformation sharingFoods & Public HealthFDA [HTML]
FOPH [HTML]
Angela Byrod09/02/2012
In effect indefinitely
United KingdomInformation SharingTobaccoFDA [HTML]
UK MHRA [HTML]
Katherine Cooper 12/13/2013
In effect indefinitely
United KingdomInformation SharingBiologicsFDA [HTML]
NIBSC [HTML]
Angela Byrod01/05/2012
In effect indefinitely
United KingdomInformation SharingFoodsFDA [HTML]
FSA [HTML]
Angela Byrod10/02/2008
In effect indefinitely
United KingdomInformation SharingDrugs, Biologics, Medical DevicesFDA [HTML]
MHRA [HTML]
Angela Byrod02/14/2005
In effect indefinitely
United KingdomInformation SharingAnimal & VeterinaryFDA [HTML]
VMD [HTML]
Angela Byrod08/22/2011
In effect indefinitely
WHOInformation sharingMedical ProductsFDA-WHO/EMP
[Pdf 550 KB]
Katherine Cooper8/15/2014
In effect indefinitely
WHOInformation SharingMedical Devices, Drugs, and BiologicsFDA-WHO/EHT/DLT [HTML]Tammie J. Bell10/10/11
In effect indefinitely
WHOInformation sharingTobaccoFDA-WHO/TFI [HTML]Tammie J. Bell04/12/2011
In effect indefinitely
WHOProducts Approved under PEPFAR and WHO’s Prequalification ProgramHealth related products (PEPFAR)FDA/WHO [HTML]Sema D. Hashemi8/11/2005
In effect indefinitely
WHOInformation sharingDrugs, human BiologicsFDA-WHO/IVB/QSS [HTML]Tammie J. Bell07/08/2008
In effect indefinitely

For additional information about the International Arrangements listed above, please contact Marie Mbaye at Marie.Mbaye@fda.hhs.gov or (301) 796-4600

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Page Last Updated: 10/10/2014
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