Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Cooperative Arrangements

Confidentiality Commitments Home
          International Programs
          International Arrangements
          Cooperative Arrangements
          Confidentiality CommitmentsCooperative Arrangements Confidentiality Commitments
  	
        Share
    Post
    Linkedin

    Email
    PrintA 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 ArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileCroatiaCyprusCzech RepublicDenmarkEcuadorEstoniaEuropean UnionFranceFinlandGuineaGermanyGreeceHungaryIndiaIndonesiaIrelandIsraelItalyJapanLatviaLiberiaLithuaniaLuxembourgMaltaMexicoNetherlandsNew ZealandPolandPortugalRomaniaSaudi ArabiaSierra LeoneSingaporeSlovakiaSloveniaSouth AfricaSpainSwedenSwitzerlandUnited KingdomWHO

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

Country
			Confidentiality Commitment Documents
			Scope
			Date Issued
			FDCA 708(c) AuthorityArgentina
			FDA
			[Spanish]

			SENASA
			[Spanish]
			Human Food, Animal Food
			12/12/2014
			NoArgentina
			FDAANMAT
			Human Food, Cosmetics, Human Medical Devices, Human Drugs, Human Biologics
			4/14/2020
			NoAustralia
			FDADAWE - Update on Australian regulatory agencies
			Human Food, Animal Food
			12/10/2020
			NoAustralia
			FDATAAD
			Human Drugs, Human Medical Devices
			12/10/2020
			NoAustralia
			FDATGA
			Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products
			08/25/2014
			NoAustralia
			FDADHA - Update on Australian regulatory agency
			Tobacco Products
			08/08/2012
			NoAustralia
			FDANICNAS
			Cosmetics
			03/8/2011
			NoAustralia
			FDAAQIS - Update on Australian regulatory agencies
			Human Food, Animal Food
			03/17/2009
			NoAustralia
			FDAAPVMA
			Animal Drugs
			10/20/2005
			NoAustralia
			FDATGA
			Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products
			08/11/2004
			NoAustralia / New Zealand
			FDAFSANZ
			Human Food, Animal Food
			04/15/2008
			NoAustria
			FDABASG
			Human Drugs, Human Biologics
			01/2/2018
			YesAustria
			FDABASG
			Human Drugs, Animal Drugs, Human Biologics, Animal Biologics
			08/18/2009
			NoBelgium
			FDAFAMHP
			Human Drugs, Human Biologics
			12/22/2017
			YesBelgium
			SIPH
			Human Foods, Animal Foods, Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices
			12/15/2004
			NoBelgium
			[FDA, FAMH]
			Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices
			04/23/2007
			NoBrazil
			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
			NoBulgaria
			FDABFSA
			Animal Drugs, Animal Biologics
			2/12/2018
			YesBulgaria
			FDABDA
			Human Drugs, Human Biologics
			09/26/2017
			YesCanada
			FDA [English] [French]HECSB [English][French]

			(2023 CC supersedes 2015 CC)
			Cosmetics, Animal Drugs, Radiation-Emitting Products, Tobacco Products
			08/08/2023
			NoCanada
			FDA [English] [French]HECSB [English] [French]

			(2023 CC supersedes 2015 CC)
			Cosmetics, Animal Drugs, Radiation-Emitting Products
			07/08/2015
			NoCanada
			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
			NoCanada
			FDA [English] [French] CSCB [English] [French]
			Limited
			3/18/2021
			NoCanada
			FDA
			[French]

			CSTD
			[French]
			Tobacco Products
			01/2/2012
			NoCanada
			FDAPHAC
			Human Biologics, Animal Biologics, Animal Food, Human Food
			09/28/2011
			NoCanada
			FDACFIA
			Human Food, Animal Food
			12/22/2003
			NoCanada
			FDAHPFB
			Human Foods, Human Medical Devices, Animal Drugs, Human Biologics, Radiation-Emitting Products
			11/18/2003
			NoCanada
			FDA (English) (French)
			TCD (English) (French)
			Tobacco Products
			4/14/2020
			NoChile
			FDA
			[Español]

			SERNAPESCA
			[Español]
			Limited
			05/17/2018
			NoChile
			FDA
			[Español]

			ISP
			[Español]
			Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics
			03/19/2012
			NoCroatia
			FDAHALMED
			Human Drugs, Human Biologics
			8/11/2017
			YesCyprus
			FDACVS
			Animal Drugs, Animal Biologics
			11/21/2022
			YesCyprus
			FDAPharmaceutical Services
			Human Drugs, Human Biologics
			10/04/2017
			YesCzech Republic
			FDAUSKVBL
			Animal Drugs, Animal Biologics
			03/17/2023
			YesCzech Republic
			FDASIDC
			Human Drugs, Human Biologics
			11/27/2017
			YesCzech Republic
			FDASIDC
			Human Drugs, Human Biologics
			09/23/2012
			NoDenmark
			FDADVFA
			Animal Food, Animal Drugs, Human Foods
			01/12/2015
			NoDenmark
			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
			NoDenmark
			FDADMA
			Human Drugs, Human Biologics
			8/11/2017
			YesEcuador
			FDAVAP

			FDA (Spanish)VAP (Spanish)
			Limited
			8/18/2022
			NoEstonia
			FDAEE SAM
			Human Drugs, Human Biologics
			09/18/2017
			YesEstonia
			FDAEE SAM
			Human Biologics, Animal Biologics, Human Drugs, Animal Drugs
			12/02/2013
			NoEurope - Council of Europe
			FDAEDQM
			Human Drugs, Animal Drugs, Human Biologics, Animal Biologics
			05/04/2009
			NoEuropean Union
			FDAECDC
			Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Food, Human Medical Devices, Animal Medical Devices
			2/18/2022
			NoEuropean Union
			(EMA and DG SANTE)
			FDAEMA and DG-SANTE
			Human Drugs, Human Biologics
			8/11/2017
			YesEuropean Union
			FDADG GROWTH
			Cosmetics, Human Medical Devices
			12/9/2016
			NoEuropean Union (EFSA)
			FDAEFSA
			Human Food, Animal Food
			07/02/2007
			NoEuropean Union (NCAR (National Competent Authority Report Exchange System))
			FDAEU
			Human Medical Devices
			07/02/2007
			NoEuropean Union
			(EC, DG SANCO)
			FDADG-SANCO - Update on European Commission Regulatory Agency
			Human Food, Animal Food, Human Biologics, Animal Biologics, Radiation-Emitting Products, Tobacco Products
			06/6/2005
			NoEuropean Union
			(EMA)
			FDAEMA
			Animal Biologics, Animal Drugs
			09/14/2010
			NoFrance
			FDAANSES
			Animal Drugs, Animal Biologics
			05/15/2018
			YesFrance
			FDAANSM
			Human Drugs, Human Biologics
			9/28/2017
			YesFrance
			FDADGAL
			Human Food, Animal Food
			12/03/2012
			NoFrance
			FDA and ANSM formerly AFSSAPSName Change notification Pdf [137 KB]
			Human Drugs, Human Biologics, Human Medical Devices, Cosmetics
			**Extended indefinitely**
			2/08/2006-2/08/2011
			NoFrance
			FDA-ANSES
			Human Food, Animal Food, Tobacco Products
			03/21/2011
			NoFinland
			FDAFIMEA
			Human Drugs, Human Biologics
			09/06/2017
			YesGermany
			FDA

			BVL
			Animal Drugs, Animal Biologics
			11/15/2023
			YesGermany
			FDAZLG/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
			YesGermany
			FDABfArM
			Human Drugs, Human Biologics
			1/19/2018
			YesGermany
			FDAPEI
			Human Drugs, Human Biologics
			10/30/2017
			YesGermany
			FDAPEI
			Human Drugs, Animal Drugs, Biologics
			01/30/2006
			NoGermany
			BFUNR-FDA
			Radiation-Emitting Products
			02/04/2005
			NoGermany
			BfArM-FDA
			Human Drugs, Human Medical Devices
			02/02/2005
			NoGermany
			BVL
			Human Foods, Animal Foods,  Tobacco Products
			02/12/2010
			NoGermany
			BMG
			Human Drugs, Human Biologics, Human Medical Devices, Radiation-Emitting Products, Tobacco Products
			01/25/2008
			NoGreece
			FDAEOF
			Human Drugs, Human Biologics
			02/28/2018
			YesGuinea
			FDAMOH
			Limited
			09/01/2015
			NoHungary
			FDANFCSO
			Animal Drugs, Animal Biologics
			04/21/2023
			YesHungary
			FDANIPN

			Update on Hungary Regulatory Agencies
			Human Drugs, Human Biologics
			11/06/2017
			YesHungary
			FDA [Pdf 1.02 MB]HMOA [Pdf 677 KB]
			Human Food, Animal Food
			04/02/2015
			NoIndia
			FDAMPEDA
			Limited
			1/19/2022
			NoIndia
			FDA to EIC [PDF 736KB]EIC to FDA
			Human Food, Limited
			7/20/2016
			NoIndonesia
			FDA

			FQIA

			Update on regulatory agency
			Limited
			7/10/2023
			NoIreland
			FDAHPRA
			Human Drugs, Human Biologics
			11/27/2017
			YesIreland
			FDAFSAI
			Human Food, Animal Food
			02/26/2013
			NoIreland
			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
			NoIreland
			INAB
			Limited
			06/14/2005
			NoIsrael
			FDAThe AdministrationUpdate to Confidentiality Commitments
			Human Drugs, Medical Devices, Human Foods, Animal Drugs, Cosmetics
			12/15/2005
			NoItaly
			FDADGSAF
			Animal Drugs, Animal Biologics
			03/21/2023
			YesItaly
			FDAAIFA
			Human Drugs, Human Biologics
			10/30/2017
			YesItaly
			FDAItalian Ministry of Health (IMOH)
			Human Food, Animal Food, Cosmetics, Tobacco Products, Human Medical devices, Animal Medical Devices
			06/27/2014
			NoItaly
			FDAAIFA
			Human Drugs, Human Biologics
			12/04/2009
			NoJapan
			FDAFSCAB and NVAL
			Animal Food, Animal Drugs
			03/16/2012
			NoJapan
			FDAPMDA
			Human Biologics, Human Drugs, Human Medical Devices
			09/15/2004
			NoJapan
			FDAPFSB - Update on Japan regulatory agency
			Human Biologics, Human Drugs, Human Medical Devices, Cosmetics
			09/15/2004
			NoLatvia
			FDA[Latvian]FVS[Latvian]
			Animal Drugs, Animal Biologics
			05/01/2018
			YesLatvia
			FDASAM
			Human Drugs, Human Biologics
			08/30/2017
			YesLiberia
			FDALMHRA
			Limited
			02/03/2015
			NoLithuania
			FDASFVS
			Animal Drugs, Animal Biologics
			11/17/2017
			YesLithuania
			FDASMCA
			Human Drugs, Human Biologics
			11/17/2017
			YesLuxembourg
			FDAHealth Directorate
			Human Drugs, Human Biologics
			05/30/2018
			YesMalta
			FDAMMA
			Human Drugs, Human Biologics
			10/4/2017
			YesMalta
			FDAVPRD
			Animal Drugs, Animal Biologics
			7/16/2019
			YesMexico
			FDA (English) (Español)COFEPRIS (English) (Español)
			Human Food, Human Drugs, Human Medical Devices, Human Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products
			04/15/2002
			NoMexico
			SAGARPA - Update on Mexican Regulatory Agency
			Human Food, Animal Food, Animal Drugs
			05/7/2004
			NoMexico
			FDA to SENASICA (English) [Español]
			Human Food, Animal Food, Animal Drugs
			7/31/2017
			NoNetherlands
			FDAMEB/HYCI
			Human Drugs, Human Biologics
			01/02/2018
			YesNetherlands
			FDARIVM
			Tobacco Products, Human Biologics, Human Drugs, Human Food, Radiation-Emitting Products
			12/01/2016
			NoNetherlands
			FDAMEB-IGZ - Update on Dutch Regulatory Agency
			Human Drugs, Animal Drugs, Human Drugs, Human Biologics, Human Medical Devices, Animal Medical Devices
			10/02/2006
			NoNew Zealand
			FDAThe Ministry
			Tobacco Products
			09/30/2011
			NoNew 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
			NoNew Zealand
			Medsafe
			Human Drugs, Human Biologics, Human Medical Devices
			03/02/2007
			NoPoland
			FDA
			[Polish]GIF
			[Polish]
			Human Drugs, Human Biologics
			07/09/2018
			YesPoland
			FDAGIF
			Human Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices
			08/22/2013
			NoPoland
			FDAURPLWMiPB
			Human Biologics, Animal Biologics, Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices
			08/22/2013
			NoPortugal
			FDADGAV
			Animal Drugs, Animal Biologics
			03/21/2023
			YesPortugal
			FDAINFARMED, I.P.
			Human Drugs, Human Biologics
			10/11/2017
			YesPortugal
			FDA
			Limited
			09/11/2013
			NoRomania
			FDAICBMV
			Animal Drugs, Animal Biologics
			03/21/2023
			YesRomania
			FDANAMMD
			Human Drugs, Human Biologics
			8/31/2017
			YesSaudi Arabia
			FDASFDA
			Limited
			10/20/2015
			NoSierra Leone
			FDAPBSL
			Limited
			03/15/2015
			NoSingapore
			FDAHSA
			Human Biologics, Cosmetics, Human Drugs, Human Medical Devices, Tobacco Products
			08/25/2004
			NoSlovakia
			FDAISCVBMN
			Animal Drugs, Animal Biologics,
			03/21/2023
			YesSlovakia
			FDASUKL
			Human Drugs, Human Biologics
			8/11/2017
			YesSlovenia
			FDAJAZMP
			Human Drugs, Human Biologics
			2/12/2018
			YesSouth Africa
			FDASAHPRA - Update on South Africa regulatory agencies
			Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices
			7/30/2018
			NoSouth Africa
			FDAMCC - Update on South Africa regulatory agencies
			Human Drugs, Human Biologics, Human Medical Devices, Cosmetics
			12/06/2004
			NoSpain
			FDAAEMPSAdditional Requirement
			Human Drugs, Human Biologics
			09/28/2017
			YesSpain
			FDAAEMPS
			Human Drugs, Animal Drugs, Human Biologics, Animal Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics
			12/18/2013
			NoSpain
			FDA (English) [Español]AESAN (English) [Español]
			Human Food, Animal Food
			03/7/2013
			NoSweden
			FDAMPA
			Human Drugs, Human Biologics, Human Medical Devices, Cosmetics
			03/31/2006
			NoSweden
			FDAMPA
			Human Drugs, Human Biologics
			06/12/2019
			YesSwitzerland
			FDASwissmedic
			Human Drugs, Human Biologics, Human Medical Devices, Animal Drugs, Animal Medical Devices, Animal Biologics
			09/17/2003
			NoSwitzerland
			FDAFOPH
			Human Drugs, Animal Drugs, Human Biologics, Animal Biologics
			09/02/2012
			NoUnited Kingdom
			FDAMHRA
			Human Drugs, Human Biologics
			11/7/2017
			YesUnited Kingdom
			FDAVMD
			Animal Drugs, Animal Biologics
			10/16/2017
			YesUnited Kingdom
			FDA to PHE CCPHE to FDA CC
			Tobacco Products
			2/28/2017
			NoUnited Kingdom
			FDA Pdf [673 KB]HFEA Pdf [813 KB]
			Human Biologics
			09/04/2015
			NoUnited Kingdom
			FDAUK MHRA
			Tobacco Products
			12/13/2013
			NoUnited 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
			NoUnited Kingdom
			FDANIBSC
			Human Biologics, Animal Biologics
			01/05/2012
			NoUnited Kingdom
			FDAVMD
			Animal Drugs, Animal Biologics
			08/22/2011
			NoUnited Kingdom
			FDAFSA
			Human Food, Animal Food
			10/02/2008
			NoUnited Kingdom
			FDAMHRA
			Human Drugs, Human Biologics, Human Medical Devices
			02/14/2005
			NoWHO
			FDA-WHO/EMP
			Limited
			09/18/2017
			NoWHO
			FDA-WHO/EMP [Pdf 550 KB] – Update on WHO/EMP
			Limited
			08/15/2014
			NoWHO
			FDA-WHO/EHT/DLT
			Human Medical Devices, Human Drugs, Human Biologics
			10/10/2011
			NoWHO
			FDA-WHO/TFI
			Tobacco Products
			04/12/2011
			NoWHO
			FDA/WHO/QSM
			LimitedUpdate on FDA/WHO/QSM Confidentiality Commitment
			08/11/2005
			NoWHO
			FDA-WHO/IVB/QSS
			Human Drugs, Human Biologics
			07/08/2008
			NoFor additional information about Confidentiality Commitments, contact OC-OGPS-IA@fda.hhs.gov or (301) 796-4600

Resources For You

Information Exchange with Other Regulators: Medical Devices
	International Programs
	International and Interagency Coordination: Food
	More Information about FDA Cooperative Arrangements
	Office of Trade, Mutual Recognition, and International Arrangements
	FDA Globalization
	News and Events

                                                                                  Content current as of:
      11/28/2023Confidentiality Commitments
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop