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 | Human Food, Animal Food | 12/12/2014 | No | |
Argentina | 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 | 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 | 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 | Animal Drugs, Animal Biologics | 2/12/2018 | Yes | |
Bulgaria | Human Drugs, Human Biologics | 09/26/2017 | Yes | |
Canada |
FDA [English] [French] (2023 CC supersedes 2015 CC) |
Cosmetics, Animal Drugs, Radiation-Emitting Products, Tobacco Products | 08/08/2023 | No |
Canada |
FDA [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 | Limited | 3/18/2021 | No | |
Canada | 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 | Limited | 05/17/2018 | No | |
Chile | 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] |
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 | 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 |
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Limited | 09/18/2017 | No | |
WHO | FDA-WHO/EMP [Pdf 550 KB] – Update on WHO/EMP | Limited | 08/15/2014 | No |
WHO | 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 | 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