International Programs

Confidentiality Commitments

 

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Country Confidentiality Commitment Documents Scope Date Issued
Argentina

FDA
[Spanish]

SENASA
[
Spanish]

Foods, Animal & Veterinary 12/12/2014
Australia FDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products 08/25/2014
Australia FDA
DHA
Tobacco 08/08/2012
Australia FDA
NICNAS
Cosmetics 03/8/2011
Australia FDA
AQIS
Foods, Animal 03/17/2009
Australia FDA
APMVA
Animal & Veterinary 10/20/2005
Australia FDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products 08/11/2004
Australia / New Zealand FDA
FSANZ
Foods 04/15/2008
Austria

FDA

BASG

Drugs, Medical Devices, Animal & Veterinary 08/18/2009
Brazil

FDA
[Portuguese]

ANVISA
[Portuguese]

Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products 09/24/2010
Belgium [SIPH] Foods, Drugs, Biologics, Medical Devices 12/15/2004
Belgium [FDA, FAMH] Drugs, Medical Devices, Animal & Veterinary 04/23/2007
Canada

FDA
[French]

CSTD
[French]

Tobacco 1/2/2012
Canada FDA
PHAC
Biologics, Food Safety 9/28/2011
Canada FDA
CFIA
Foods 12/22/2003
Canada FDA
HPFB of Health Canada
Foods, Medical Devices, Animal & Veterinary Drugs, Biologics, Radiation-Emitting Products 11/18/2003
Chile

FDA
[Español]

ISP
[Español]

Foods, Drugs, Medical Device, biologics, and Cosmetics 03/19/2012
Czech Republic FDA
SIDC
Drugs, Biologics and Vaccines 09/23/2012
Denmark FDA
DVFA
Foods, Animal & Veterinary Products 1/12/2015
Denmark

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

Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products 2/24/2014
Denmark FDA
DMA
Drugs and Medical Devices 11/14/2007
Estonia FDA
EE SAM
Drugs, Biologics, Animal & Veterinary Medical Products 12/02/2013
Europe - Council of Europe FDA
EDQM
Drugs, Biologics, Animal & Veterinary Products 05/04/2009
European Union EC, DG Enterprise FDA
DG-Enterprise
N/A,
responsibilities transferred to DG SANCO
07/02/2007-07/02/2012
European Union EC, DG Enterprise FDA
DG-Enterprise
N/A,
Responsibilities transferred to DG SANCO
07/02/2007-07/02/2012
European Union (EFSA) FDA
EFSA
Foods 07/02/2007
European Union
(EMA)
FDA
EMA
Drugs, Biologics, Animal & Veterinary Products 09/14/2003
European Union
(EC, DG SANCO)
FDA
DG-SANCO
Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products 6/6/2005
France FDA
DGAL
Foods 12/03/2012
France

FDA and ANSM formerly AFSSAPS

Name Change notification Pdf [137 KB]

Drugs, Biologics, Medical Devices, Cosmetics Extended indefinitely
2/08/2006-2/08/2011
France FDA-ANSES Foods, Animal & Veterinary 3/21/2011
Germany FDA
PEI
Drugs, Biologics and Animal & Veterinary 1/30/2006
Germany BFUNR-FDA Foods and Radiation-Emitting Products 02/04/2005
Germany BfArM-FDA Drugs, Medical Devices 02/02/2005
Germany BVL Foods, Animal & Veterinary and Tobacco Products 02/12/2010
Germany BMG Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting andTobacco Products 01/25/2008
Hungary FDA [Pdf 1.02 MB]
HMOA [Pdf 677 KB]
Foods 4/2/2015
Ireland FDA
FSAI
Foods 2/26/2013
Ireland FDA [Pdf 1.8 MB]
HPRA [Pdf 590 KB]
Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics 9/20/2005
Ireland INAB Good laboratory practices 06/14/2005
Israel FDA
The Administration
Drugs, Medical Devices, Foods, Veterinary Drugs, Cosmetics, Radiation-Emitting Products 12/15/2005
Italy FDA
Italian Ministry of Health (IMOH)
Food, animal & veterinary, cosmetics, tobacco, IMOH-regulated medical devices 06/27/2014
Italy FDA
AIFA
Drugs 12/04/2009
Japan FDA
FSCAB and NVAL
Animal Foods and feeds, Veterinary drugs 3/16/2012
Japan FDA
PMDA
Biologics, Human Drugs, and Medical Devices 09/15/2004
Japan FDA
PFSB
Biologics, Cosmetics, Human Drugs, Food and Medical Devices 09/15/2004
Mexico

FDA
[Español]

COFEPRIS
[Español]

Foods, Drugs, Medical Devices, Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products 04/15/2002
Mexico SAGARPA Foods, Animal & Veterinary 5/7/2004
Netherlands FDA
MEB-IGZ
Drugs, Biologics, Medical Devices, Animal & Veterinary, Foods 10/02/2006
New Zealand FDA
The Ministry
Tobacco Products 9/30/2011
New Zealand FDA [Pdf 109KB]
NZ MPI [Pdf 48KB]
(formerly NZFSA, with which FDA had a Confidentiality Commitment since 2004)
Foods 4/20/2015
New Zealand Medsafe Drugs, Biologics, Medical Devices, Radiation-Emitting Products 03/02/2007
Poland FDA
GIF
Biologics, Medical Products for Human and Veterinary Use, Medical Devices 08/22/2013
Poland FDA
URPLWMiPB
Biologics, Medical Products for Human and Veterinary Use, Medical Devices 08/22/2013
Portugal FDA Seafood 09/11/2013
Singapore FDA
HSA
Biologics, Cosmetics, Human Drugs, Medical Devices and Tobacco Products 8/25/2004
South Africa FDA
MCC
Biologics and Human Drugs, and Veterinary Products 12/06/2004
Spain FDA
AEMPS
Drugs, Biologics, Medical Devices, Cosmetics, Animal & Veterinary Medicines, and Radiation-Emitting Products 12/18/2013
Spain

FDA
[Español]

AESAN
[Español]

Foods 3/7/2013
Sweden FDA
MPA
Drugs, Biologics, Medical Devices, Cosmetics 03/31/2006
Switzerland Swissmedic Drugs, Biologics, Medical Devices, Animal & Veterinary 9/17/2003
Switzerland FDA
FOPH
Foods & Public Health 09/02/2012
United Kingdom FDA
UK MHRA
Tobacco 12/13/2013
United Kingdom FDA [Pdf 317 KB]
DH [Pdf 697 KB]
Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary 06/16/2015
United Kingdom FDA
NIBSC
Biologics 01/05/2012
United Kingdom FDA
FSA
Foods 10/02/2008
United Kingdom FDA
MHRA
Drugs, Biologics, Medical Devices 02/14/2005
United Kingdom FDA
VMD
Animal & Veterinary 08/22/2011
WHO FDA-WHO/EMP [Pdf 550 KB] Medical Products 8/15/2014
WHO FDA-WHO/EHT/DLT Medical Devices, Drugs,andBiologics 10/10/11
WHO FDA-WHO/TFI Tobacco 04/12/2011
WHO FDA/WHO Health related products (PEPFAR) 8/11/2005
WHO FDA-WHO/IVB/QSS Drugs, human Biologics 07/08/2008
 

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

 

Page Last Updated: 06/26/2015
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