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Confidentiality Commitments

A Confidentiality Commitment (CC) is a document that sets up the legal framework for FDA to share certain kinds of non-public information with FDA counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities.

A CC must be in place in order for FDA to share non-public information with a counterpart, but a CC never requires FDA (or its counterpart) to share information.

Narrow results by:

Country Confidentiality Commitment Documents Scope Date Issued 708c Authority
Argentina

FDA
[Spanish]

SENASA
[Spanish]

 Human Food, Animal Food 12/12/2014  
Argentina

FDA
ANMAT

 Human Food, Cosmetics, Human Medical Devices, Human Drugs, Human Biologics 4/14/2020  
Australia FDA
DAWE - Update on Australian regulatory agencies		 Human Food, Animal Food 12/10/2020  
Australia FDA
TAAD		 Human Drugs, Human Medical Devices 12/10/2020  
Australia FDA
TGA		 Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products 08/25/2014  
Australia FDA
DHA - Update on Australian regulatory agency		 Tobacco Products 08/08/2012  
Australia FDA
NICNAS		 Cosmetics 03/8/2011  
Australia FDA
AQIS - Update on Australian regulatory agencies		 Human Food, Animal Food 03/17/2009  
Australia FDA
APVMA		 Animal Drugs 10/20/2005  
Australia FDA
TGA		 Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products 08/11/2004  
Australia / New Zealand FDA
FSANZ		 Human Food, Animal Food 04/15/2008  
Austria FDA
BASG		 Human Drugs, Human Biologics 01/2/2018 Yes
Austria

FDA
BASG

 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics 08/18/2009  
Belgium FDA
FAMHP		 Human Drugs, Human Biologics 12/22/2017 Yes
Belgium SIPH Human Foods, Animal Foods, Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices  12/15/2004  
Belgium [FDA, FAMH] Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices 04/23/2007  
Brazil

FDA (English) [Portuguese]
ANVISA (English) [Portuguese]

 Human Foods, Animal Foods, Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics, Radiation-Emitting Products, Tobacco Products 09/24/2010  
Bulgaria

FDA
BFSA

 Animal Drugs, Animal Biologics 2/12/2018 Yes
Bulgaria

FDA
BDA

 Human Drugs, Human Biologics 09/26/2017 Yes
Canada FDA [English] [French]
HECSB (English) [French]		 Cosmetics, Animal Drugs, Radiation-Emitting Products 07/08/2015  
Canada FDA [English] [French]
RORB [English] [French]
Update to Confidentiality Commitments		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Radiation-Emitting Products, Tobacco, Human Food, Animal Food 02/28/2018  
Canada

FDA [English] [French] 
CSCB [English] [French]

 Limited 3/18/2021  
Canada

FDA
[French]

CSTD
[French]

 Tobacco Products 01/2/2012  
Canada FDA
PHAC		 Human Biologics, Animal Biologics, Animal Food, Human Food 09/28/2011  
Canada FDA
CFIA		 Human Food, Animal Food 12/22/2003  
Canada FDA
HPFB		 Human Foods, Human Medical Devices, Animal Drugs, Human Biologics, Radiation-Emitting Products 11/18/2003  
Canada FDA (English) (French)
TCD (English) (French)		 Tobacco Products 4/14/2020  
Chile

FDA
[Español]

SERNAPESCA
[Español]

 Limited 05/17/2018  
Chile

FDA
[Español]

ISP
[Español]

 Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics 03/19/2012  
Croatia FDA
HALMED		 Human Drugs, Human Biologics 8/11/2017 Yes
Cyprus FDA
CVS		 Animal Drugs, Animal Biologics 11/21/2022 Yes
Cyprus FDA
Pharmaceutical Services		 Human Drugs, Human Biologics 10/04/2017 Yes
Czech Republic FDA
USKVBL		 Animal Drugs, Animal Biologics 03/17/2023  
Czech Republic FDA
SIDC		 Human Drugs, Human Biologics 11/27/2017 Yes
Czech Republic FDA
SIDC		 Human Drugs, Human Biologics 09/23/2012  
Denmark FDA
DVFA		 Animal Food, Animal Drugs, Human Foods 01/12/2015  
Denmark

FDA [Pdf 696 KB]
DMA [Pdf 1.11 MB]

 Human Biologics, Animal Biologics, Human Medical Devices, Human Drugs, Animal Drugs, Radiation-Emitting Products, Tobacco Products 05/19/2016  
Denmark FDA
DMA		 Human Drugs, Human Biologics 8/11/2017  Yes
Ecuador

FDA
VAP

FDA (Spanish)
VAP (Spanish)

 Limited 8/18/2022  
Estonia FDA
EE SAM		 Human Drugs, Human Biologics 09/18/2017 Yes
Estonia FDA
EE SAM		 Human Biologics, Animal Biologics, Human Drugs, Animal Drugs 12/02/2013  
Europe - Council of Europe FDA
EDQM		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics 05/04/2009  
European Union FDA
ECDC		 Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Food, Human Medical Devices, Animal Medical Devices 2/18/2022  
European Union
(EMA and DG SANTE)		 FDA
EMA and DG-SANTE		 Human Drugs, Human Biologics 8/11/2017 Yes
European Union FDA
DG GROWTH		 Cosmetics, Human Medical Devices 12/9/2016  
European Union (EFSA) FDA
EFSA		 Human Food, Animal Food 07/02/2007  
European Union (NCAR (National Competent Authority Report Exchange System)) FDA
EU		 Human Medical Devices 07/02/2007  
European Union
(EC, DG SANCO)

FDA
DG-SANCO - Update on European Commission Regulatory Agency

 Human Food, Animal Food, Human Biologics, Animal Biologics, Radiation-Emitting Products, Tobacco Products 06/6/2005  
European Union
(EMA)		 FDA
EMA		 Animal Biologics, Animal Drugs 09/14/2003  
France FDA
ANSES		 Animal Drugs, Animal Biologics 05/15/2018 Yes
France FDA
ANSM		 Human Drugs, Human Biologics 9/28/2017 Yes
France FDA
DGAL		 Human Food, Animal Food 12/03/2012  
France

FDA and ANSM formerly AFSSAPS
Name Change notification Pdf [137 KB]

 Human Drugs, Human Biologics, Human Medical Devices, Cosmetics Extended indefinitely
2/08/2006-2/08/2011		  
France FDA-ANSES Human Food, Animal Food, Tobacco Products 03/21/2011  
Finland FDA
FIMEA		 Human Drugs, Human Biologics 09/06/2017 Yes
Germany FDA
ZLG/Länder Authorities*
*The Confidentiality Commitment from ZLG is understood to be a commitment from ZLG and the Länder Authorities		 Human Drugs, Human Biologics 10/24/2019 Yes
Germany FDA
BfArM		 Human Drugs, Human Biologics 1/19/2018 Yes
Germany FDA
PEI		 Human Drugs, Human Biologics 10/30/2017 Yes
Germany FDA
PEI		 Human Drugs, Animal Drugs, Biologics 01/30/2006  
Germany BFUNR-FDA Radiation-Emitting Products 02/04/2005  
Germany BfArM-FDA Human Drugs, Human Medical Devices 02/02/2005  
Germany BVL Human Foods, Animal Foods,  Tobacco Products 02/12/2010  
Germany BMG Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products, Tobacco Products 01/25/2008  
Greece FDA
EOF		 Human Drugs, Human Biologics 02/28/2018 Yes
 
Guinea FDA
MOH		 Limited 09/01/2015  
Hungary FDA
NFCSO		 Animal Drugs, Animal Biologics 04/21/2023 Yes
Hungary FDA
NIPN		 Human Drugs, Human Biologics 11/06/2017 Yes
Hungary FDA [Pdf 1.02 MB]
HMOA [Pdf 677 KB]		 Human Food, Animal Food 04/02/2015  
India FDA
MPEDA		 Limited 1/19/2022  
India FDA to EIC [PDF 736KB]
EIC to FDA		 Human Food, Limited 7/20/2016  
Indonesia

FDA

FQIA

 Limited 7/10/2023  
Ireland FDA
HPRA		 Human Drugs, Human Biologics 11/27/2017 Yes
Ireland FDA
FSAI		 Human Food, Animal Food 02/26/2013  
Ireland FDA [Pdf 1.8 MB]
HPRA [Pdf 590 KB]		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics 09/20/2005  
Ireland INAB Limited 06/14/2005  
Israel FDA
The Administration
Update to Confidentiality Commitments		 Human Drugs, Medical Devices, Human Foods, Animal Drugs, Cosmetics 12/15/2005  
Italy FDA
DGSAF		 Animal Drugs, Animal Biologics 03/21/2023 Yes
Italy FDA
AIFA		 Human Drugs, Human Biologics 10/30/2017 Yes
Italy FDA
Italian Ministry of Health (IMOH)		 Human Food, Animal Food, Cosmetics, Tobacco Products, Human Medical devices, Animal Medical Devices 06/27/2014  
Italy FDA
AIFA		 Human Drugs, Human Biologics 12/04/2009  
Japan FDA
FSCAB and NVAL		 Animal Food, Animal Drugs 03/16/2012  
Japan FDA
PMDA		 Human Biologics, Human Drugs, Human Medical Devices 09/15/2004  
Japan FDA
PFSB - Update on Japan regulatory agency		 Human Biologics, Cosmetics, Human Drugs, Human Food, Human Medical Devices 09/15/2004  
Latvia FDA
[Latvian]
FVS
[Latvian]		 Animal Drugs, Animal Biologics 05/01/2018 Yes
Latvia FDA
SAM		 Human Drugs, Human Biologics 08/30/2017 Yes
Liberia

FDA
LMHRA

 Limited 02/03/2015  
Lithuania FDA
SFVS		 Animal Drugs, Animal Biologics 11/17/2017 Yes
Lithuania FDA
SMCA		 Human Drugs, Human Biologics 11/17/2017 Yes
Luxembourg FDA
Health Directorate		 Human Drugs, Human Biologics 05/30/2018 Yes
Malta FDA
MMA		 Human Drugs, Human Biologics 10/4/2017 Yes
Malta FDA
VPRD		 Animal Drugs, Animal Biologics 7/16/2019 Yes
Mexico

FDA (English) (Español)
COFEPRIS (English) (Español)

 Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products 04/15/2002  
Mexico SAGARPA - Update on Mexican Regulatory Agency Human Food, Animal Food, Animal Drugs 05/7/2004  
Mexico FDA to SENASICA (English) [Español] Human Food, Animal Food, Animal Drugs 7/31/2017  
Netherlands FDA
MEB/HYCI		 Human Drugs, Human Biologics 01/02/2018 Yes
Netherlands FDA
RIVM		 Tobacco Products, Human Biologics, Human Drugs, Human Food, Radiation-Emitting Products 12/01/2016  
Netherlands FDA
MEB-IGZ - Update on Dutch Regulatory Agency		 Human Drugs, Animal Drugs, Human Drugs, Human Biologics, Human Medical Devices, Animal Medical Devices 10/02/2006  
New Zealand FDA
The Ministry		 Tobacco Products 09/30/2011  
New Zealand FDA [Pdf 109KB]
NZ MPI [Pdf 48KB]
(formerly NZFSA, with which FDA had a Confidentiality Commitment since 2004)		 Human Food, Animal Food 05/14/2015  
New Zealand Medsafe Human Drugs, Human Biologics, Human Medical Devices 03/02/2007  
Poland FDA
[Polish]
GIF
[Polish]		 Human Drugs, Human Biologics 07/09/2018 Yes
Poland FDA
GIF		 Human Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices 08/22/2013  
Poland FDA
URPLWMiPB		 Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices 08/22/2013  
Portugal FDA
DGAV		 Animal Drugs, Animal Biologics 03/21/2023 Yes
Portugal FDA
INFARMED, I.P.		 Human Drugs, Human Biologics 10/11/2017 Yes
Portugal FDA Limited 09/11/2013  
Romania FDA
ICBMV		 Animal Drugs, Animal Biologics 03/21/2023 Yes
Romania FDA
NAMMD		 Human Drugs, Human Biologics 8/31/2017 Yes
Saudi Arabia FDA
SFDA		 Limited 10/20/2015  
Sierra Leone

FDA
PBSL

 Limited 03/15/2015  
Singapore FDA
HSA		 Human Biologics, Cosmetics, Human Drugs, Human Medical Devices, Tobacco Products 08/25/2004  
Slovakia FDA
ISCVBMN		 Animal Drugs, Animal Biologics, 03/21/2023 Yes
Slovakia FDA
SUKL		 Human Drugs, Human Biologics 8/11/2017 Yes
Slovenia FDA
JAZMP		 Human Drugs, Human Biologics 2/12/2018 Yes
South Africa FDA
SAHPRA - Update on South Africa regulatory agencies		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices 7/30/2018  
South Africa FDA
MCC - Update on South Africa regulatory agencies		 Human Drugs, Human Biologics, Human Medical Devices, Cosmetics 12/06/2004  
Spain FDA
AEMPS

Additional Requirement		 Human Drugs, Human Biologics 09/28/2017 Yes
Spain FDA
AEMPS		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics 12/18/2013  
Spain

FDA (English) [Español]
AESAN (English) [Español]

 Human Food, Animal Food 03/7/2013  
Sweden FDA
MPA		 Human Drugs, Human Biologics, Human Medical Devices, Cosmetics 03/31/2006  
Sweden FDA
MPA		 Human Drugs, Human Biologics 06/12/2019 Yes
Switzerland

FDA
Swissmedic

 Human Drugs, Human Biologics, Human Medical Devices, Animal Drugs, Animal Medical Devices, Animal Biologics 09/17/2003  
Switzerland FDA
FOPH		 Human Drugs, Animal Drugs, Human Biologics, Animal Biologics 09/02/2012  
United Kingdom FDA
MHRA		 Human Drugs, Human Biologics 11/7/2017 Yes
United Kingdom FDA
VMD		 Animal Drugs, Animal Biologics 10/16/2017 Yes
United Kingdom FDA to PHE CC
PHE to FDA CC		 Tobacco Products 2/28/2017  
United Kingdom FDA Pdf [673 KB]
HFEA Pdf [813 KB]		 Human Biologics 09/04/2015  
United Kingdom FDA
UK MHRA		 Tobacco Products 12/13/2013  
United Kingdom FDA [Pdf 317 KB]
DHSC  [Pdf 697 KB]
Update to Confidentiality Commitments		 Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products 06/16/2015  
United Kingdom FDA
NIBSC		 Human Biologics, Animal Biologics 01/05/2012  
United Kingdom FDA
VMD		 Animal Drugs, Animal Biologics 08/22/2011  
United Kingdom FDA
FSA		 Human Food, Animal Food 10/02/2008  
United Kingdom FDA
MHRA		 Human Drugs, Human Biologics, Human Medical Devices 02/14/2005  
WHO FDA-WHO/EMP Limited 09/18/2017  
WHO FDA-WHO/EMP [Pdf 550 KB] – Update on WHO/EMP Limited 08/15/2014  
WHO FDA-WHO/EHT/DLT Human Medical Devices, Human Drugs, Human Biologics 10/10/2011  
WHO FDA-WHO/TFI Tobacco Products 04/12/2011  
WHO FDA/WHO/QSM

 		 Limited

Update on FDA/WHO/QSM Confidentiality Commitment		 08/11/2005  
WHO FDA-WHO/IVB/QSS Human Drugs, Human Biologics 07/08/2008  

For additional information about Confidentiality Commitments, contact OC-OGPS-IA@fda.hhs.gov or (301) 796-4600

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