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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 FDCA 708(c) Authority
Argentina

FDA
[Spanish]

SENASA
[
Spanish]

Human Food, Animal Food 12/12/2014 No
Argentina

FDA
ANMAT

Human Food, Cosmetics, Human Medical Devices, Human Drugs, Human Biologics 4/14/2020 No
Australia FDA
DAWE - Update on Australian regulatory agencies
Human Food, Animal Food 12/10/2020 No
Australia FDA
TAAD
Human Drugs, Human Medical Devices 12/10/2020 No
Australia FDA
TGA
Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products 08/25/2014 No
Australia FDA
DHA - Update on Australian regulatory agency
Tobacco Products 08/08/2012 No
Australia FDA
NICNAS
Cosmetics 03/8/2011 No
Australia FDA
AQIS - Update on Australian regulatory agencies
Human Food, Animal Food 03/17/2009 No
Australia FDA
APVMA
Animal Drugs 10/20/2005 No
Australia FDA
TGA
Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products 08/11/2004 No
Australia / New Zealand FDA
FSANZ
Human Food, Animal Food 04/15/2008 No
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 No
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 No
Belgium [FDA, FAMH] Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices 04/23/2007 No
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 No
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]

(2023 CC supersedes 2015 CC)

Cosmetics, Animal Drugs, Radiation-Emitting Products, Tobacco Products 08/08/2023 No
Canada

FDA [English] [French]
HECSB [English] [French]

(2023 CC supersedes 2015 CC)

Cosmetics, Animal Drugs, Radiation-Emitting Products 07/08/2015 No
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 No
Canada

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

Limited 3/18/2021 No
Canada

FDA
[French]

CSTD
[French]

Tobacco Products 01/2/2012 No
Canada FDA
PHAC
Human Biologics, Animal Biologics, Animal Food, Human Food 09/28/2011 No
Canada FDA
CFIA
Human Food, Animal Food 12/22/2003 No
Canada FDA
HPFB
Human Foods, Human Medical Devices, Animal Drugs, Human Biologics, Radiation-Emitting Products 11/18/2003 No
Canada FDA (English) (French)
TCD (English) (French)
Tobacco Products 4/14/2020 No
Chile

FDA
[Español]

SERNAPESCA
[Español]

Limited 05/17/2018 No
Chile

FDA
[Español]

ISP
[Español]

Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics 03/19/2012 No
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 Yes
Czech Republic FDA
SIDC
Human Drugs, Human Biologics 11/27/2017 Yes
Czech Republic FDA
SIDC
Human Drugs, Human Biologics 09/23/2012 No
Denmark FDA
DVFA
Animal Food, Animal Drugs, Human Foods 01/12/2015 No
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 No
Denmark FDA
DMA
Human Drugs, Human Biologics 8/11/2017  Yes
Ecuador

FDA
VAP

FDA (Spanish)
VAP (Spanish)

Limited 8/18/2022 No
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 No
Europe - Council of Europe FDA
EDQM
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics 05/04/2009 No
European Union FDA
ECDC
Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Food, Human Medical Devices, Animal Medical Devices 2/18/2022 No
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 No
European Union (EFSA) FDA
EFSA
Human Food, Animal Food 07/02/2007 No
European Union (NCAR (National Competent Authority Report Exchange System)) FDA
EU
Human Medical Devices 07/02/2007 No
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 No
European Union
(EMA)
FDA
EMA
Animal Biologics, Animal Drugs 09/14/2010 No
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 No
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
No
France FDA-ANSES Human Food, Animal Food, Tobacco Products 03/21/2011 No
Finland FDA
FIMEA
Human Drugs, Human Biologics 09/06/2017 Yes
Germany

FDA

BVL

Animal Drugs, Animal Biologics 11/15/2023 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 No
Germany BFUNR-FDA Radiation-Emitting Products 02/04/2005 No
Germany BfArM-FDA Human Drugs, Human Medical Devices 02/02/2005 No
Germany BVL Human Foods, Animal Foods,  Tobacco Products 02/12/2010 No
Germany BMG Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products, Tobacco Products 01/25/2008 No
Greece FDA
EOF
Human Drugs, Human Biologics 02/28/2018 Yes
 
Guinea FDA
MOH
Limited 09/01/2015 No
Hungary FDA
NFCSO
Animal Drugs, Animal Biologics 04/21/2023 Yes
Hungary

FDA
NIPN

Update on Hungary Regulatory Agencies

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 No
India FDA
MPEDA
Limited 1/19/2022 No
India FDA to EIC [PDF 736KB]
EIC to FDA
Human Food, Limited 7/20/2016 No
Indonesia

FDA

FQIA

Update on regulatory agency

Limited 7/10/2023 No
Ireland FDA
HPRA
Human Drugs, Human Biologics 11/27/2017 Yes
Ireland FDA
FSAI
Human Food, Animal Food 02/26/2013 No
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 No
Ireland INAB Limited 06/14/2005 No
Israel

FDA 
MTIR

Cosmetics, Animal Biologics, Human Biologics, Animal Drugs, Human Drugs, Animal Medical Devices, Human Medical Devices, Radiation Emitting Devices 06/10/2024 No
Israel FDA
The Administration
Update to Confidentiality Commitments
Human Foods 12/15/2005 No
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 No
Italy FDA
AIFA
Human Drugs, Human Biologics 12/04/2009 No
Japan FDA
FSCAB and NVAL
Animal Food, Animal Drugs 03/16/2012 No
Japan FDA
PMDA
Human Biologics, Human Drugs, Human Medical Devices 09/15/2004 No
Japan FDA
PFSB - Update on Japan regulatory agency
Human Biologics, Human Drugs, Human Medical Devices, Cosmetics 09/15/2004 No
Kenya

FDA

MDIVD

Human Medical Devices 3/15/2024 No
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 No
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 No
Mexico SAGARPA - Update on Mexican Regulatory Agency Human Food, Animal Food, Animal Drugs 05/7/2004 No
Mexico FDA to SENASICA (English) [Español] Human Food, Animal Food, Animal Drugs 7/31/2017 No
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 No
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 No
New Zealand FDA
The Ministry
Tobacco Products 09/30/2011 No
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 No
New Zealand Medsafe Human Drugs, Human Biologics, Human Medical Devices 03/02/2007 No
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 No
Poland FDA
URPLWMiPB
Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices 08/22/2013 No
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 No
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 No
Sierra Leone

FDA
PBSL

Limited 03/15/2015 No
Singapore FDA
HSA
Human Biologics, Cosmetics, Human Drugs, Human Medical Devices, Tobacco Products 08/25/2004 No
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 No
South Africa FDA
MCC - Update on South Africa regulatory agencies
Human Drugs, Human Biologics, Human Medical Devices, Cosmetics 12/06/2004 No
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 No
Spain

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

Human Food, Animal Food 03/7/2013 No
Sweden FDA
MPA
Human Drugs, Human Biologics, Human Medical Devices, Cosmetics 03/31/2006 No
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 No
Switzerland FDA
FOPH
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics 09/02/2012 No
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 No
United Kingdom FDA Pdf [673 KB]
HFEA Pdf [813 KB]
Human Biologics 09/04/2015 No
United Kingdom FDA
UK MHRA
Tobacco Products 12/13/2013 No
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 No
United Kingdom FDA
NIBSC
Human Biologics, Animal Biologics 01/05/2012 No
United Kingdom FDA
VMD
Animal Drugs, Animal Biologics 08/22/2011 No
United Kingdom FDA
FSA
Human Food, Animal Food 10/02/2008 No
United Kingdom FDA
MHRA
Human Drugs, Human Biologics, Human Medical Devices 02/14/2005 No
WHO

FDA-WHO/EMP

Update to Confidentiality Commitment

Limited 09/18/2017 No
WHO FDA-WHO/EMP [Pdf 550 KB] – Update on WHO/EMP Limited 08/15/2014 No
WHO

FDA-WHO/EHT/DLT

Update to Confidentiality Commitment

Human Medical Devices, Human Drugs, Human Biologics 10/10/2011 No
WHO FDA-WHO/TFI Tobacco Products 04/12/2011 No
WHO FDA/WHO/QSM

Update to Confidentiality Commitment
Limited

 
08/11/2005 No
WHO

FDA-WHO/IVB/QSS

Update to Confidentiality Commitment

Human Drugs, Human Biologics 07/08/2008 No

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

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