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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:

CountryConfidentiality Commitment DocumentsScopeDate IssuedFDCA 708(c) Authority
Argentina

FDA
[Spanish]

SENASA
[Spanish]

Human Food, Animal Food12/12/2014No
ArgentinaFDA
ANMAT
Human Food, Cosmetics, Human Medical Devices, Human Drugs, Human Biologics4/14/2020No
AustraliaFDA
DAWE - Update on Australian regulatory agencies
Human Food, Animal Food12/10/2020No
AustraliaFDA
TAAD
Human Drugs, Human Medical Devices12/10/2020No
AustraliaFDA
TGA
Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products08/25/2014No
AustraliaFDA
DHA - Update on Australian regulatory agency
Tobacco Products08/08/2012No
AustraliaFDA
NICNAS
Cosmetics03/8/2011No
AustraliaFDA
AQIS - Update on Australian regulatory agencies
Human Food, Animal Food03/17/2009No
AustraliaFDA
APVMA
Animal Drugs10/20/2005No
AustraliaFDA
TGA
Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products08/11/2004No
Australia / New ZealandFDA
FSANZ
Human Food, Animal Food04/15/2008No
AustriaFDA
BASG
Human Drugs, Human Biologics01/2/2018Yes
AustriaFDA
BASG
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics08/18/2009No
BelgiumFDA
FAMHP
Human Drugs, Human Biologics12/22/2017Yes
BelgiumSIPHHuman Foods, Animal Foods, Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices12/15/2004No
Belgium[FDA, FAMH]Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices04/23/2007No
BrazilFDA (English) [Portuguese]
ANVISA (English) [Portuguese]
Human Drugs, Human Biologics09/30/2024Yes
BrazilFDA (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 Products09/24/2010No
BulgariaFDA
BFSA
Animal Drugs, Animal Biologics2/12/2018Yes
BulgariaFDA
BDA
Human Drugs, Human Biologics09/26/2017Yes
Canada

FDA [English][French]

HPFB and ROEB Health Canada [English][French]

Human Drugs, Human Biologics, Animal Drugs, Animal Biologics 01/14/2025

Yes

Canada

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

(2023 CC supersedes 2015 CC)

Cosmetics, Animal Drugs, Radiation-Emitting Products, Tobacco Products08/08/2023No
Canada

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

(2023 CC supersedes 2015 CC)

Cosmetics, Animal Drugs, Radiation-Emitting Products07/08/2015No
CanadaFDA [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 Food02/28/2018No
CanadaFDA [English] [French] 
CSCB [English] [French]
Limited3/18/2021No
Canada

FDA
[French]

CSTD
[French]

Tobacco Products01/2/2012No
CanadaFDA
PHAC
Human Biologics, Animal Biologics, Animal Food, Human Food09/28/2011No
CanadaFDA
CFIA
Human Food, Animal Food12/22/2003No
CanadaFDA
HPFB
Human Drugs, Human Foods, Human Medical Devices, Animal Drugs, Animal Biologics, Human Biologics, Radiation-Emitting Products11/18/2003No
CanadaFDA (English) (French)
TCD (English) (French)
Tobacco Products4/14/2020No
Chile

FDA
[Español]

SERNAPESCA
[Español]

Limited05/17/2018No
Chile

FDA
[Español]

ISP
[Español]

Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics03/19/2012No
CroatiaFDA
HALMED
Human Drugs, Human Biologics8/11/2017Yes
CyprusFDA
CVS
Animal Drugs, Animal Biologics11/21/2022Yes
CyprusFDA
Pharmaceutical Services
Human Drugs, Human Biologics10/04/2017Yes
Czech RepublicFDA
CAFIA
Human Food07/9/2024No
Czech RepublicFDA
MZCR
Human Food07/9/2024No
Czech RepublicFDA
USKVBL
Animal Drugs, Animal Biologics03/17/2023Yes
Czech RepublicFDA
SIDC
Human Drugs, Human Biologics11/27/2017Yes
Czech RepublicFDA
SIDC
Human Drugs, Human Biologics09/23/2012No
DenmarkFDA
DVFA
Animal Food, Animal Drugs, Human Foods01/12/2015No
DenmarkFDA [Pdf 696 KB]
DMA [Pdf 1.11 MB]
Human Biologics, Animal Biologics, Human Medical Devices, Human Drugs, Animal Drugs, Radiation-Emitting Products, Tobacco Products05/19/2016No
DenmarkFDA
DMA
Human Drugs, Human Biologics08/11/2017Yes
Ecuador

FDA
VAP

FDA (Spanish)
VAP (Spanish)

Limited08/18/2022No
EstoniaFDA
EE SAM
Human Drugs, Human Biologics09/18/2017Yes
EstoniaFDA
EE SAM
Human Biologics, Animal Biologics, Human Drugs, Animal Drugs12/02/2013No
Europe - Council of EuropeFDA
EDQM
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics05/04/2009No
European UnionFDA
ECDC
Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Food, Human Medical Devices, Animal Medical Devices2/18/2022No
European Union
(EMA and DG SANTE)
FDA
EMA and DG-SANTE
Human Drugs, Human Biologics8/11/2017Yes
European UnionFDA
DG GROWTH
Cosmetics, Human Medical Devices12/9/2016No
European Union (EFSA)FDA
EFSA
Human Food, Animal Food07/02/2007No
European Union (NCAR (National Competent Authority Report Exchange System))FDA
EU
Human Medical Devices07/02/2007No
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 Products06/6/2005No
European Union
(EMA)
FDA
EMA
Animal Biologics, Animal Drugs09/14/2010No
FranceFDA
ANSES
Animal Drugs, Animal Biologics05/15/2018Yes
FranceFDA
ANSM
Human Drugs, Human Biologics9/28/2017Yes
FranceFDA
DGAL
Human Food, Animal Food12/03/2012No
FranceFDA and ANSM formerly AFSSAPS
Name Change notification Pdf [137 KB]
Human Drugs, Human Biologics, Human Medical Devices, CosmeticsExtended indefinitely
2/08/2006-2/08/2011
No
FranceFDA-ANSESHuman Food, Animal Food, Tobacco Products03/21/2011No
FinlandFDA
FIMEA
Human Drugs, Human Biologics09/06/2017Yes
Germany

FDA

BVL

Animal Drugs, Animal Biologics11/15/2023Yes
GermanyFDA
ZLG/Länder Authorities*
*The Confidentiality Commitment from ZLG is understood to be a commitment from ZLG and the Länder Authorities
Human Drugs, Human Biologics10/24/2019Yes
GermanyFDA
BfArM
Human Drugs, Human Biologics1/19/2018Yes
GermanyFDA
PEI
Human Drugs, Human Biologics10/30/2017Yes
GermanyFDA
PEI
Human Drugs, Animal Drugs, Biologics01/30/2006No
GermanyBFUNR-FDARadiation-Emitting Products02/04/2005No
GermanyBfArM-FDAHuman Drugs, Human Medical Devices02/02/2005No
GermanyBVLHuman Foods, Animal Foods, Tobacco Products02/12/2010No
GermanyBMGHuman Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products, Tobacco Products01/25/2008No
Greece

FDA

EFET

Human Food07/9/2024No
GreeceFDA
EOF
Human Drugs, Human Biologics02/28/2018Yes
 
GuineaFDA
MOH
Limited09/01/2015No
HungaryFDA
NFCSO
Animal Drugs, Animal Biologics04/21/2023Yes
Hungary

FDA
NIPN

Update on Hungary Regulatory Agencies

Human Drugs, Human Biologics11/06/2017Yes
HungaryFDA [Pdf 1.02 MB]
HMOA [Pdf 677 KB]
Human Food, Animal Food04/02/2015No
IndiaFDA
MPEDA
Limited1/19/2022No
IndiaFDA to EIC [PDF 736KB]
EIC to FDA
Human Food, Limited7/20/2016No
Indonesia

FDA

FQIA

Update on regulatory agency

Limited7/10/2023No
IrelandFDA
HPRA
Human Drugs, Human Biologics11/27/2017Yes
IrelandFDA
FSAI
Human Food, Animal Food02/26/2013No
IrelandFDA [Pdf 1.8 MB]
HPRA [Pdf 590 KB]
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics09/20/2005No
IrelandINABLimited06/14/2005No
IsraelFDA 
MTIR
Cosmetics, Animal Biologics, Human Biologics, Animal Drugs, Human Drugs, Animal Medical Devices, Human Medical Devices, Radiation Emitting Devices06/10/2024No
IsraelFDA
The Administration
Update to Confidentiality Commitments
Human Foods12/15/2005No
ItalyFDA
DGSAF
Animal Drugs, Animal Biologics03/21/2023Yes
ItalyFDA
AIFA
Human Drugs, Human Biologics10/30/2017Yes
ItalyFDA
Italian Ministry of Health (IMOH)
Human Food, Animal Food, Cosmetics, Tobacco Products, Human Medical devices, Animal Medical Devices06/27/2014No
ItalyFDA
AIFA
Human Drugs, Human Biologics12/04/2009No
Japan

FDA

PHB

Human Food8/8/2024No
JapanFDA
FSCAB and NVAL
Animal Food, Animal Drugs03/16/2012No
JapanFDA
PMDA
Human Biologics, Human Drugs, Human Medical Devices09/15/2004No
JapanFDA
PFSB - Update on Japan regulatory agency
Human Biologics, Human Drugs, Human Medical Devices, Cosmetics09/15/2004No
Kenya

FDA

MDIVD

Human Medical Devices3/15/2024No
LatviaFDA
[Latvian]
FVS
[Latvian]
Animal Drugs, Animal Biologics05/01/2018Yes
LatviaFDA
SAM
Human Drugs, Human Biologics08/30/2017Yes
LiberiaFDA
LMHRA
Limited02/03/2015No
LithuaniaFDA
SFVS
Animal Drugs, Animal Biologics11/17/2017Yes
LithuaniaFDA
SMCA
Human Drugs, Human Biologics11/17/2017Yes
LuxembourgFDA
Health Directorate
Human Drugs, Human Biologics05/30/2018Yes
MaltaFDA
MMA
Human Drugs, Human Biologics10/4/2017Yes
MaltaFDA
VPRD
Animal Drugs, Animal Biologics7/16/2019Yes
MexicoFDA (English) (Español)
COFEPRIS (English) (Español)
Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products04/15/2002No
MexicoSAGARPA - Update on Mexican Regulatory AgencyHuman Food, Animal Food, Animal Drugs05/7/2004No
MexicoFDA to SENASICA (English) [Español]Human Food, Animal Food, Animal Drugs7/31/2017No
NetherlandsFDA
MEB/HYCI
Human Drugs, Human Biologics01/02/2018Yes
NetherlandsFDA
RIVM
Tobacco Products, Human Biologics, Human Drugs, Human Food, Radiation-Emitting Products12/01/2016No
NetherlandsFDA
MEB-IGZ - Update on Dutch Regulatory Agency
Human Drugs, Animal Drugs, Human Drugs, Human Biologics, Human Medical Devices, Animal Medical Devices10/02/2006No
New ZealandFDA
The Ministry
Tobacco Products09/30/2011No
New ZealandFDA [Pdf 109KB]
NZ MPI [Pdf 48KB]
(formerly NZFSA, with which FDA had a Confidentiality Commitment since 2004)
Human Food, Animal Food05/14/2015No
New ZealandMedsafeHuman Drugs, Human Biologics, Human Medical Devices03/02/2007No
PolandFDA
[Polish]
GIF
[Polish]
Human Drugs, Human Biologics07/09/2018Yes
PolandFDA
GIF
Human Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices08/22/2013No
PolandFDA
URPLWMiPB
Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices08/22/2013No
Portugal

FDA

ASAE

Human Food06/12/2024No
PortugalFDA
DGAV
Animal Drugs, Animal Biologics03/21/2023Yes
PortugalFDA
INFARMED, I.P.
Human Drugs, Human Biologics10/11/2017Yes
PortugalFDALimited09/11/2013No
RomaniaFDA
ICBMV
Animal Drugs, Animal Biologics03/21/2023Yes
RomaniaFDA
NAMMD
Human Drugs, Human Biologics8/31/2017Yes
Saudi ArabiaFDA
SFDA
Limited10/20/2015No
Sierra LeoneFDA
PBSL
Limited03/15/2015No
SingaporeFDA
HSA
Human Biologics, Cosmetics, Human Drugs, Human Medical Devices, Tobacco Products08/25/2004No
SlovakiaFDA
ISCVBMN
Animal Drugs, Animal Biologics,03/21/2023Yes
SlovakiaFDA
SUKL
Human Drugs, Human Biologics8/11/2017Yes
SloveniaFDA
JAZMP
Human Drugs, Human Biologics2/12/2018Yes
South AfricaFDA
SAHPRA - Update on South Africa regulatory agencies
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices7/30/2018No
South AfricaFDA
MCC - Update on South Africa regulatory agencies
Human Drugs, Human Biologics, Human Medical Devices, Cosmetics12/06/2004No
SpainFDA
AEMPS

Additional Requirement
Human Drugs, Human Biologics09/28/2017Yes
SpainFDA
AEMPS
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics12/18/2013No
SpainFDA (English) [Español]
AESAN (English) [Español]
Human Food, Animal Food03/7/2013No
SwedenFDA
MPA
Human Drugs, Human Biologics, Human Medical Devices, Cosmetics03/31/2006No
SwedenFDA
MPA
Human Drugs, Human Biologics06/12/2019Yes
SwitzerlandFDA
Swissmedic
Human Drugs, Human Biologics, Human Medical Devices, Animal Drugs, Animal Medical Devices, Animal Biologics09/17/2003No
SwitzerlandFDA
FOPH
Human Drugs, Animal Drugs, Human Biologics, Animal Biologics09/02/2012No
Ukraine

FDA

SECMOH

Limited07/26/2024No
United KingdomFDA
MHRA
Human Drugs, Human Biologics11/7/2017Yes
United KingdomFDA
VMD
Animal Drugs, Animal Biologics10/16/2017Yes
United KingdomFDA to PHE CC
PHE to FDA CC
Tobacco Products2/28/2017No
United KingdomFDA Pdf [673 KB]
HFEA Pdf [813 KB]
Human Biologics09/04/2015No
United KingdomFDA
UK MHRA
Tobacco Products12/13/2013No
United KingdomFDA [Pdf 317 KB]
DHSC [Pdf 697 KB]
Update to Confidentiality Commitments
Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products06/16/2015No
United KingdomFDA
NIBSC
Human Biologics, Animal Biologics01/05/2012No
United KingdomFDA
VMD
Animal Drugs, Animal Biologics08/22/2011No
United KingdomFDA
FSA
Human Food, Animal Food10/02/2008No
United KingdomFDA
MHRA
Human Drugs, Human Biologics, Human Medical Devices02/14/2005No
WHO

FDA-WHO/EMP

Update to Confidentiality Commitment

Limited09/18/2017No
WHOFDA-WHO/EMP [Pdf 550 KB] – Update on WHO/EMPLimited08/15/2014No
WHO

FDA-WHO/EHT/DLT

Update to Confidentiality Commitment

Human Medical Devices, Human Drugs, Human Biologics10/10/2011No
WHOFDA-WHO/TFITobacco Products04/12/2011No
WHOFDA/WHO/QSM

Update to Confidentiality Commitment
Limited

 
08/11/2005No
WHO

FDA-WHO/IVB/QSS

Update to Confidentiality Commitment

Human Drugs, Human Biologics07/08/2008No

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

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