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Confidentiality Commitments

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
Switzerland FDA to Swissmedic Drugs, Biologics, Medical Devices, Animal & Veterinary 9/17/2003
Argentina

FDA
[Spanish]

SENASA
[
Spanish]

Foods, Animal & Veterinary 12/12/2014
Austria FDA
BASG
Drugs 01/2/2018
Australia FDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products 08/25/2014
Australia FDA
DHA
Tobacco 08/08/2012
Australia FDA
NICNAS
Cosmetics 03/8/2011
Australia FDA
AQIS
Foods, Animal 03/17/2009
Australia FDA
APVMA
Animal & Veterinary 10/20/2005
Australia FDA
TGA
Drugs, Biologics, Medical Devices, Radiation-Emitting Products 08/11/2004
Australia / New Zealand FDA
FSANZ
Foods 04/15/2008
Austria

FDA

BASG

Drugs, Medical Devices, Animal & Veterinary 08/18/2009
Brazil

FDA
[Portuguese]

ANVISA
[Portuguese]

Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products 09/24/2010
Belgium FDA
FAMHP
Drugs 12/22/2017
Belgium [SIPH] Foods, Drugs, Biologics, Medical Devices 12/15/2004
Belgium [FDA, FAMH] Drugs, Medical Devices, Animal & Veterinary 04/23/2007
Bulgaria

FDA
BFSA

Veterinary Drugs 2/12/2018
Bulgaria

FDA
BDA

Drugs 09/26/2017
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 [Pdf 786KB]
[French] [Pdf 864KB]

HECSB [Pdf 907KB]
[French] [Pdf 1MB]

Cosmetics, Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary 07/8/2015
Canada

FDA
[French]

CSTD
[French]

Tobacco 01/2/2012
Canada FDA
PHAC
Biologics, Food Safety 09/28/2011
Canada FDA
CFIA
Foods, Animal & Veterinary 12/22/2003
Canada FDA
HPFB of Health Canada
Foods, Medical Devices, Animal & Veterinary Drugs, Biologics, Radiation-Emitting Products 11/18/2003
Chile

FDA
[Español]

SERNAPESCA
[Español]

Seafood 05/17/2018
Chile

FDA
[Español]

ISP
[Español]

Foods, Drugs, Medical Device, biologics, and Cosmetics 03/19/2012
Croatia FDA
HALMED
Drugs 8/11/2017
Cyprus FDA
Pharmaceutical Services
Drugs 10/04/2017
Czech Republic FDA
SIDC
Drugs 11/27/2017
Czech Republic FDA
SIDC
Drugs, Biologics and Vaccines 09/23/2012
Denmark FDA
DVFA
Foods, Animal & Veterinary Products 01/12/2015
Denmark

FDA [Pdf 696 KB]
DMA [Pdf 1.11 MB]

Foods, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products 05/19/2016
Denmark FDA
DMA
Drugs 8/11/2017
Estonia FDA
EE SAM
Drugs 09/18/2017
Estonia FDA
EE SAM
Biologics, Animal & Veterinary Medical Products 12/02/2013
Europe - Council of Europe FDA
EDQM
Drugs, Biologics, Animal & Veterinary Products 05/04/2009
European Union
(EMA and DG SANTE)
FDA
EMA and DG-SANTE
Drug 8/11/2017
European Union FDA to DG GROWTH
DG GROWTH to FDA
Cosmetics and Medical Devices 12/9/2016
European Union (EFSA) FDA
EFSA
Foods 07/02/2007
European Union (NCAR(National Competent Authority Report Exchange System)) FDA
EU
Medical Devices 07/02/2007
European Union
(EC, DG SANCO)
FDA
DG-SANCO
Foods, Biologics, Animal & Veterinary, Radiation-Emitting Products, Tobacco Products 06/6/2005
European Union
(EMA)
FDA
EMA
Biologics, Animal & Veterinary Products 09/14/2003
France FDA
ANSES
Veterinary Drugs 05/15/2018
France FDA
ANSM
Drugs 9/28/2017
France FDA
DGAL
Foods 12/03/2012
France

FDA and ANSM formerly AFSSAPS

Name Change notification Pdf [137 KB]

Drugs, Biologics, Medical Devices, Cosmetics Extended indefinitely
2/08/2006-2/08/2011
France FDA-ANSES Foods, Animal & Veterinary, Tobacco 03/21/2011
Finland FDA
FIMEA
Drugs 09/06/2017
Germany FDA
BfArM
Drugs 1/19/2018
Germany FDA
PEI
Drugs 10/30/2017
Germany FDA
PEI
Drugs, Biologics and Animal & Veterinary 01/30/2006
Germany BFUNR-FDA Foods and Radiation-Emitting Products 02/04/2005
Germany BfArM-FDA Drugs, Medical Devices 02/02/2005
Germany BVL Foods, Animal & Veterinary and Tobacco Products 02/12/2010
Germany BMG Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting and Tobacco Products 01/25/2008
Greece FDA
EOF
Drugs 2/28/2018
Hungary FDA
NIPN
Drugs 11/06/2017
Hungary FDA [Pdf 1.02 MB]
HMOA [Pdf 677 KB]
Foods 04/02/2015
India FDA to EIC [PDF 736KB]
EIC to FDA
Food, Limited 7/20/2016
Ireland FDA
HPRA
Drugs 11/27/2017
Ireland FDA
FSAI
Foods 02/26/2013
Ireland FDA [Pdf 1.8 MB]
HPRA [Pdf 590 KB]
Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics 09/20/2005
Ireland INAB Good laboratory practices 06/14/2005
Israel FDA
The Administration
Drugs, Medical Devices, Foods, Veterinary Drugs, Cosmetics, Radiation-Emitting Products 12/15/2005
Italy FDA
AIFA
Drugs 10/30/2017
Italy FDA
Italian Ministry of Health (IMOH)
Food, animal & veterinary, cosmetics, Tobacco, IMOH-regulated medical devices 06/27/2014
Italy FDA
AIFA
Drugs 12/04/2009
Japan FDA
FSCAB and NVAL
Animal Foods and feeds, Veterinary drugs 03/16/2012
Japan FDA
PMDA
Biologics, Human Drugs, and Medical Devices 09/15/2004
Japan FDA
PFSB
Biologics, Cosmetics, Human Drugs, Food and Medical Devices 09/15/2004
Latvia FDA
[Latvian]
FVS
[Latvian]
Veterinary Drugs 05/01/2018
Latvia FDA
SAM
Drugs 08/30/2017
Lithuania FDA
SFVS
Veterinary Drugs 11/17/2017
Lithuania FDA
SMCA
Drugs 11/17/2017
Luxembourg FDA
Health Directorate
Drugs 05/30/2018
Malta FDA
MMA
Drugs 10/04/2017
Mexico

FDA
[Español]

COFEPRIS
[Español]

Foods, Drugs, 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]
Foods, Animal & Veterinary 7/31/2017
Netherlands FDA
MEB/HYCI
Drugs 01/02/2018
Netherlands FDA to RIVM
RIVM to FDA
Tobacco Products, Biologics, Drugs, Food, Radiation-Emitting Products 12/01/2016
Netherlands FDA
MEB-IGZ
Drugs, Biologics, Medical Devices, Animal & Veterinary, 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)
Foods 05/14/2015
New Zealand Medsafe Drugs, Biologics, Medical Devices, Radiation-Emitting Products 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.
Drugs 10/11/2017
Portugal FDA Seafood 09/11/2013
Romania FDA
NAMMD
Drugs 8/31/2017
Singapore FDA
HSA
Biologics, Cosmetics, Human Drugs, Medical Devices and Tobacco Products 08/25/2004
Slovakia FDA
SUKL
Drugs 8/11/2017
Slovenia FDA
JAZMP
Drugs 2/12/2018
South Africa FDA
SAHPRA - Update on South Africa regulatory agencies
Drugs, Biologics, Medical Devices (including in vitro diagnostics and radiological health products), Cosmetics and Dietary Supplements  7/30/2018
South Africa FDA
MCC - Update on South Africa regulatory agencies
Biologics and Human Drugs, and Veterinary Products 12/06/2004
Spain FDA
AEMPS

Additional Requirement
Drugs 09/28/2017
Spain FDA
AEMPS
Drugs, Biologics, Medical Devices, Cosmetics, Animal & Veterinary Medicines, and Radiation-Emitting Products 12/18/2013
Spain

FDA
[Español]

AESAN
[Español]

Foods 03/7/2013
Sweden FDA
MPA
Drugs, Biologics, Medical Devices, Cosmetics 03/31/2006
Sweden FDA
MPA
Drugs 06/12/2019
Switzerland Swissmedic Drugs, Biologics, Medical Devices, Animal & Veterinary 09/17/2003
Switzerland FDA
FOPH
Foods & Public Health 09/02/2012
United Kingdom FDA
MHRA
Drugs 11/7/2017
United Kingdom FDA
VMD
Veterinary 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 12/13/2013
United Kingdom FDA [Pdf 317 KB]
DH [Pdf 697 KB]
Drugs, Biologics, Medical Devices, Radiation-Emitting Products, Tobacco, Foods, Animal & Veterinary 06/16/2015
United Kingdom FDA
NIBSC
Biologics 01/05/2012
United Kingdom FDA
VMD
Animal & Veterinary 08/22/2011
United Kingdom FDA
FSA
Foods 10/02/2008
United Kingdom FDA
MHRA
Drugs, Biologics, Medical Devices 02/14/2005
WHO FDA-WHO/EMP INN Program 09/18/2017
WHO FDA-WHO/EMP [Pdf 550 KB] Medical Products 08/15/2014
WHO FDA-WHO/EHT/DLT Medical Devices, Drugs,andBiologics 10/10/11
WHO FDA-WHO/TFI Tobacco 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 Drugs, human Biologics 07/08/2008

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

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