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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Scope

Country	Confidentiality Commitment Documents	Scope	Date Issued
Saudi Arabia	FDA SFDA	Medical Products	10/20/2015
Australia	FDA DAWE - Update on Australian regulatory agencies	Foods, Animal	12/10/2020
Australia	FDA TAAD	Medical Products/Drugs	12/10/2020
Germany	FDA ZLG/Länder Authorities* *The Confidentiality Commitment from ZLG is understood to be a commitment from ZLG and the Länder Authorities	Drugs	10/24/2019
Switzerland	FDA to Swissmedic	Drugs, Biologics, Medical Devices, Animal & Veterinary	9/17/2003
Argentina	FDA [Spanish] SENASA [Spanish]	Human Food, Animal Food	12/12/2014
Argentina	FDA ANMAT	Human Food, Cosmetics, Human Medical Devices, Human Drugs, and Biologics	4/14/2020
Austria	FDA BASG	Drugs	01/2/2018
Australia	FDA TGA	Human Drugs, 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, 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, Animal Drugs Biologics	08/18/2009
Brazil	FDA [Portuguese] ANVISA [Portuguese]	Human Foods, Animal Foods, Human Drugs, Animal Drugs, Biologics, Human Medical Devices, Animal Medical Devices, Cosmetics, Radiation-Emitting Products, Tobacco Products	09/24/2010
Belgium	FDA FAMHP	Human Drugs	12/22/2017
Belgium	[SIPH]	Human Foods, Human Drugs, Biologics, Medical Devices	12/15/2004
Belgium	[FDA, FAMH]	Human Drugs, Animal Drugs, Human Medical Devices, Animal Medical Devices	04/23/2007
Bulgaria	FDA BFSA	Veterinary Drugs	2/12/2018
Bulgaria	FDA BDA	Human Drugs	09/26/2017
Canada	FDA [French] HECSB [French]	Controlled Substances, Cosmetics, Animal and Veterinary, Radiation-Emitting Products	07/08/2015
Canada	FDA [French] RORB [French] Update to Confidentiality Commitments	Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary	02/28/2018
Canada	FDA [French] CSCB [French]	Limited	3/18/2021
Canada	FDA [French] CSTD [French]	Tobacco Products	01/2/2012
Canada	FDA PHAC	Biologics, Animal Food, Human Food	09/28/2011
Canada	FDA CFIA	Human Food, Animal Food	12/22/2003
Canada	FDA HPFB of Health Canada	Human Foods, Human Medical Devices, Animal Drugs, 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, Biologics, Cosmetics	03/19/2012
Croatia	FDA HALMED	Human Drugs	8/11/2017
Cyprus	FDA Pharmaceutical Services	Human Drugs	10/04/2017
Czech Republic	FDA SIDC	Human Drugs	11/27/2017
Czech Republic	FDA SIDC	Human Drugs, Biologics	09/23/2012
Denmark	FDA DVFA	Animal Food, Animal Drugs	01/12/2015
Denmark	FDA [Pdf 696 KB] DMA [Pdf 1.11 MB]	Biologics, Human Medical Devices, Animal Drugs, Radiation-Emitting Products, Tobacco Products	05/19/2016
Denmark	FDA DMA	Human Drugs	8/11/2017
Estonia	FDA EE SAM	Human Drugs	09/18/2017
Estonia	FDA EE SAM	Biologics, Animal Drugs	12/02/2013
Europe - Council of Europe	FDA EDQM	Human Drugs, Animal Drugs, Biologics	05/04/2009
European Union (EMA and DG SANTE)	FDA EMA and DG-SANTE	Human Drugs	8/11/2017
European Union	FDA to DG GROWTH DG GROWTH to FDA	Cosmetics, 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	Human Food, Animal Food, Biologics, Radiation-Emitting Products, Tobacco Products	06/6/2005
European Union (EMA)	FDA EMA	Biologics, Animal Drugs	09/14/2003
France	FDA ANSES	Animal Drugs	05/15/2018
France	FDA ANSM	Human Drugs	9/28/2017
France	FDA DGAL	Human Food, Animal Food	12/03/2012
France	FDA and ANSM formerly AFSSAPS Name Change notification Pdf [137 KB]	Human Drugs, Biologics, 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	09/06/2017
Germany	FDA BfArM	Human Drugs	1/19/2018
Germany	FDA PEI	Human Drugs	10/30/2017
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, Biologics, Human Medical Devices, Radiation-Emitting Products, Tobacco Products	01/25/2008
Greece	FDA EOF	Human Drugs	2/28/2018
Hungary	FDA NIPN	Human Drugs	11/06/2017
Hungary	FDA [Pdf 1.02 MB] HMOA [Pdf 677 KB]	Human Food, Animal Food	04/02/2015
India	FDA to EIC [PDF 736KB] EIC to FDA	Human Food, Limited	7/20/2016
Ireland	FDA HPRA	Human Drugs	11/27/2017
Ireland	FDA FSAI	Human Food, Animal Food	02/26/2013
Ireland	FDA [Pdf 1.8 MB] HPRA [Pdf 590 KB]	Human Drugs, Animal Drugs, 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 AIFA	Human Drugs	10/30/2017
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	12/04/2009
Japan	FDA FSCAB and NVAL	Animal Food, Animal Drugs	03/16/2012
Japan	FDA PMDA	Biologics, Human Drugs, Human Medical Devices	09/15/2004
Japan	FDA PFSB - Update on Japan regulatory agency	Biologics, Cosmetics, Human Drugs, Food and Medical Devices	09/15/2004
Latvia	FDA [Latvian] FVS [Latvian]	Animal Drugs	05/01/2018
Latvia	FDA SAM	Human Drugs	08/30/2017
Lithuania	FDA SFVS	Animal Drugs	11/17/2017
Lithuania	FDA SMCA	Human Drugs	11/17/2017
Luxembourg	FDA Health Directorate	Human Drugs	05/30/2018
Malta	FDA MMA	Human Drugs	10/4/2017
Malta	FDA VPRD	Animal Drugs	7/16/2019
Mexico	FDA – COFEPRIS (English) [FDA – COFEPRIS (Espanol)] COFEPRIS – FDA (English) [COFEPRIS – FDA (Espanol)]	Human Food, Human Drugs, Human Medical Devices, Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products	04/15/2002
Mexico	SAGARPA	Foods, Animal & Veterinary	05/7/2004
Mexico	FDA to SENASICA [Español]	Human Food, Animal Food, Veterinary Drugs	7/31/2017
Netherlands	FDA MEB/HYCI	Human Drugs	01/02/2018
Netherlands	FDA to RIVM RIVM to FDA	Tobacco Products, Biologics, Human Drugs, Human Food, Radiation-Emitting Products	12/01/2016
Netherlands	FDA MEB-IGZ	Human Drugs, Animal Drugs Biologics, Human Medical Devices, Animal Medical Devices Animal Foods	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, Biologics, Human Medical Devices	03/02/2007
Poland	FDA [Polish] GIF [Polish]	Drugs	07/09/2018
Poland	FDA GIF	Biologics, Medical Products for Human and Veterinary Use, Medical Devices	08/22/2013
Poland	FDA URPLWMiPB	Biologics, Medical Products for Human and Veterinary Use, Medical Devices	08/22/2013
Portugal	FDA INFARMED, I.P.	Human Drugs	10/11/2017
Portugal	FDA	Seafood	09/11/2013
Romania	FDA NAMMD	Limited	8/31/2017
Singapore	FDA HSA	Biologics, Cosmetics, Human Drugs, Human Medical Devices and Tobacco Products	08/25/2004
Slovakia	FDA SUKL	Human Drugs	8/11/2017
Slovenia	FDA JAZMP	Human Drugs	2/12/2018
South Africa	FDA SAHPRA - Update on South Africa regulatory agencies	Human Drugs, Veterinary Drugs Biologics, Medical Devices	7/30/2018
South Africa	FDA MCC - Update on South Africa regulatory agencies	Human Drugs, Biologics, Medical Devices, Cosmetics	12/06/2004
Spain	FDA AEMPS Additional Requirement	Human Drugs	09/28/2017
Spain	FDA AEMPS	Human Drugs, Animal Drugs Biologics, Medical Devices, Cosmetics	12/18/2013
Spain	FDA [Español] AESAN [Español]	Human Food, Animal Food	03/7/2013
Sweden	FDA MPA	Human Drugs, Biologics, Human Medical Devices, Cosmetics	03/31/2006
Sweden	FDA MPA	Human Drugs	06/12/2019
Switzerland	Swissmedic	Human Drugs, Biologics, Medical Devices, Veterinary Drugs	09/17/2003
Switzerland	FDA FOPH	Human Drugs, Animal Drugs, Biologics	09/02/2012
United Kingdom	FDA MHRA	Human Drugs	11/7/2017
United Kingdom	FDA VMD	Animal Drugs	10/16/2017
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]	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, Biologics, Human Medical Devices, Radiation-Emitting Products	06/16/2015
United Kingdom	FDA NIBSC	Biologics	01/05/2012
United Kingdom	FDA VMD	Animal Drugs	08/22/2011
United Kingdom	FDA FSA	Human Food, Animal Food	10/02/2008
United Kingdom	FDA MHRA	Human Drugs, Biologics, Human Medical Devices	02/14/2005
WHO	FDA-WHO/EMP	INN Program	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, Biologics	10/10/11
WHO	FDA-WHO/TFI	Tobacco Products	04/12/2011
WHO	FDA/WHO/QSM	Prequalification of Medical Products Update on FDA/WHO/QSM Confidentiality Commitment	08/11/2005
WHO	FDA-WHO/IVB/QSS	Human Drugs, Biologics	07/08/2008

For additional information about Confidentiality Commitments, contact [email protected] or (301) 796-4600

U.S. Food and Drug Administration

Confidentiality Commitments

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