International Programs

Confidentiality Commitments

 

(Search results update automatically as you type)
 

Narrow results by:
(search results updates with each selection)

 


 
CountryConfidentiality Commitment DocumentsScopeDate Issued
Argentina

FDA
[Spanish]

SENASA
[
Spanish]

Foods, Animal & Veterinary12/12/2014
AustraliaFDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products08/25/2014
AustraliaFDA
DHA
Tobacco08/08/2012
AustraliaFDA
NICNAS
Cosmetics03/8/2011
AustraliaFDA
AQIS
Foods, Animal03/17/2009
AustraliaFDA
APMVA
Animal & Veterinary10/20/2005
AustraliaFDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products08/11/2004
Australia / New ZealandFDA
FSANZ
Foods04/15/2008
Austria

FDA

BASG

Drugs, Medical Devices, Animal & Veterinary08/18/2009
Brazil

FDA
[Portuguese]

ANVISA
[Portuguese]

Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products09/24/2010
Belgium[SIPH]Foods, Drugs, Biologics, Medical Devices12/15/2004
Belgium[FDA, FAMH]Drugs, Medical Devices, Animal & Veterinary04/23/2007
Canada

FDA [Pdf 786KB]
[French] [Pdf 864KB]

HECSB [Pdf 907KB]
[French] [Pdf 1MB]

Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary7/8/2015
Canada

FDA
[French]

CSTD
[French]

Tobacco1/2/2012
CanadaFDA
PHAC
Biologics, Food Safety9/28/2011
CanadaFDA
CFIA
Foods12/22/2003
CanadaFDA
HPFB of Health Canada
Foods, Medical Devices, Animal & Veterinary Drugs, Biologics, Radiation-Emitting Products11/18/2003
Chile

FDA
[Español]

ISP
[Español]

Foods, Drugs, Medical Device, biologics, and Cosmetics03/19/2012
Czech RepublicFDA
SIDC
Drugs, Biologics and Vaccines09/23/2012
DenmarkFDA
DVFA
Foods, Animal & Veterinary Products1/12/2015
Denmark

FDA [Pdf 2.71 MB]
DHMA [Pdf 1.11 MB]

Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products2/24/2014
DenmarkFDA
DMA
Drugs and Medical Devices11/14/2007
EstoniaFDA
EE SAM
Drugs, Biologics, Animal & Veterinary Medical Products12/02/2013
Europe - Council of EuropeFDA
EDQM
Drugs, Biologics, Animal & Veterinary Products05/04/2009
European Union EC, DG EnterpriseFDA
DG-Enterprise
N/A,
responsibilities transferred to DG SANCO
07/02/2007-07/02/2012
European Union EC, DG EnterpriseFDA
DG-Enterprise
N/A,
Responsibilities transferred to DG SANCO
07/02/2007-07/02/2012
European Union (EFSA)FDA
EFSA
Foods07/02/2007
European Union
(EMA)
FDA
EMA
Drugs, Biologics, Animal & Veterinary Products09/14/2003
European Union
(EC, DG SANCO)
FDA
DG-SANCO
Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products6/6/2005
FranceFDA
DGAL
Foods12/03/2012
France

FDA and ANSM formerly AFSSAPS

Name Change notification Pdf [137 KB]

Drugs, Biologics, Medical Devices, CosmeticsExtended indefinitely
2/08/2006-2/08/2011
FranceFDA-ANSESFoods, Animal & Veterinary3/21/2011
GermanyFDA
PEI
Drugs, Biologics and Animal & Veterinary1/30/2006
GermanyBFUNR-FDAFoods and Radiation-Emitting Products02/04/2005
GermanyBfArM-FDADrugs, Medical Devices02/02/2005
GermanyBVLFoods, Animal & Veterinary and Tobacco Products02/12/2010
GermanyBMGFoods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting andTobacco Products01/25/2008
HungaryFDA [Pdf 1.02 MB]
HMOA [Pdf 677 KB]
Foods4/2/2015
IrelandFDA
FSAI
Foods2/26/2013
IrelandFDA [Pdf 1.8 MB]
HPRA [Pdf 590 KB]
Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics9/20/2005
IrelandINABGood laboratory practices06/14/2005
IsraelFDA
The Administration
Drugs, Medical Devices, Foods, Veterinary Drugs, Cosmetics, Radiation-Emitting Products12/15/2005
ItalyFDA
Italian Ministry of Health (IMOH)
Food, animal & veterinary, cosmetics, tobacco, IMOH-regulated medical devices06/27/2014
ItalyFDA
AIFA
Drugs12/04/2009
JapanFDA
FSCAB and NVAL
Animal Foods and feeds, Veterinary drugs3/16/2012
JapanFDA
PMDA
Biologics, Human Drugs, and Medical Devices09/15/2004
JapanFDA
PFSB
Biologics, Cosmetics, Human Drugs, Food and Medical Devices09/15/2004
Mexico

FDA
[Español]

COFEPRIS
[Español]

Foods, Drugs, Medical Devices, Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products04/15/2002
MexicoSAGARPAFoods, Animal & Veterinary5/7/2004
NetherlandsFDA
MEB-IGZ
Drugs, Biologics, Medical Devices, Animal & Veterinary, Foods10/02/2006
New ZealandFDA
The Ministry
Tobacco Products9/30/2011
New ZealandFDA [Pdf 109KB]
NZ MPI [Pdf 48KB]
(formerly NZFSA, with which FDA had a Confidentiality Commitment since 2004)
Foods4/20/2015
New ZealandMedsafeDrugs, Biologics, Medical Devices, Radiation-Emitting Products03/02/2007
PolandFDA
GIF
Biologics, Medical Products for Human and Veterinary Use, Medical Devices08/22/2013
PolandFDA
URPLWMiPB
Biologics, Medical Products for Human and Veterinary Use, Medical Devices08/22/2013
PortugalFDASeafood09/11/2013
SingaporeFDA
HSA
Biologics, Cosmetics, Human Drugs, Medical Devices and Tobacco Products8/25/2004
South AfricaFDA
MCC
Biologics and Human Drugs, and Veterinary Products12/06/2004
SpainFDA
AEMPS
Drugs, Biologics, Medical Devices, Cosmetics, Animal & Veterinary Medicines, and Radiation-Emitting Products12/18/2013
Spain

FDA
[Español]

AESAN
[Español]

Foods3/7/2013
SwedenFDA
MPA
Drugs, Biologics, Medical Devices, Cosmetics03/31/2006
SwitzerlandSwissmedicDrugs, Biologics, Medical Devices, Animal & Veterinary9/17/2003
SwitzerlandFDA
FOPH
Foods & Public Health09/02/2012
United KingdomFDA
UK MHRA
Tobacco12/13/2013
United KingdomFDA [Pdf 317 KB]
DH [Pdf 697 KB]
Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary06/16/2015
United KingdomFDA
NIBSC
Biologics01/05/2012
United KingdomFDA
FSA
Foods10/02/2008
United KingdomFDA
MHRA
Drugs, Biologics, Medical Devices02/14/2005
United KingdomFDA
VMD
Animal & Veterinary08/22/2011
WHOFDA-WHO/EMP [Pdf 550 KB]Medical Products8/15/2014
WHOFDA-WHO/EHT/DLTMedical Devices, Drugs,andBiologics10/10/11
WHOFDA-WHO/TFITobacco04/12/2011
WHOFDA/WHOHealth related products (PEPFAR)8/11/2005
WHOFDA-WHO/IVB/QSSDrugs, human Biologics07/08/2008
 

For additional information about the International Arrangements listed above, please contact OC-OIP-IAD or (301) 796-4600

 

Page Last Updated: 07/20/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.