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.

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Country ArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileCroatiaCyprusCzech RepublicDenmarkEcuadorEstoniaEuropean UnionFranceFinlandGuineaGermanyGreeceHungaryIndiaIndonesiaIrelandIsraelItalyJapanKenyaLatviaLiberiaLithuaniaLuxembourgMaltaMexicoNetherlandsNew ZealandPolandPortugalRomaniaSaudi ArabiaSierra LeoneSingaporeSlovakiaSloveniaSouth AfricaSpainSwedenSwitzerlandUkraineUnited KingdomWHO

Scope CosmeticsBiologics, AnimalBiologics, HumanDrugs, AnimalDrugs, HumanFood, AnimalFood, HumanMedical Devices, AnimalMedical Devices, HumanRadiation-Emitting DevicesTobacco ProductsLimited

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 Drugs, Human Biologics	09/30/2024	Yes
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] 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 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 Drugs, Human Foods, Human Medical Devices, Animal Drugs, Animal Biologics, 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 CAFIA	Human Food	07/9/2024	No
Czech Republic	FDA MZCR	Human Food	07/9/2024	No
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	08/11/2017	Yes
Ecuador	FDA VAP FDA (Spanish) VAP (Spanish)	Limited	08/18/2022	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 EFET	Human Food	07/9/2024	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 PHB	Human Food	8/8/2024	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 ASAE	Human Food	06/12/2024	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
Ukraine	FDA SECMOH	Limited	07/26/2024	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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