International Programs

Memoranda of Understanding and Other Cooperative Arrangements

COUNTRYSUBJECTLINKSCONTACTDATES
Effective/Expiration
Australia, Brazil, and Canada (Multilateral)Cooperation in the Medical Device Single Audit ProgramEnglish: [HTML]
French: [HTML]
Portuguese: [HTML]
Katherine Cooper 11/17/2012
In effect indefinitely
AustraliaPharmaceutical Good Manufacturing Practice Inspections 
 
[HTML]Sema Hashemi 10/11/2000
In effect indefinitely
AustraliaDry Milk Products


 
[HTML]Sema Hashemi 

11/28/1979 

In effect Indefinitely

AustraliaShellfish Safety


 
[HTML]Sema Hashemi 9/12/1986
In effect indefinitely
AustraliaAnimal Pharmaceuticals Exchange of Information 

 
[HTML]Sema Hashemi 2/18/1997
In effect indefinitely
AustraliaMedical Device Good Manufacturing Practices Inspection Information 

 
[HTML]Sema Hashemi 2/17/1993
In effect indefinitely
AustraliaOrphan Products[HTML]Sema Hashemi 8/13/1997
In effect indefinitely
BrazilCooperation to Enhance Activities of Mutual InterestEnglish [HTML]
Portuguese [HTML]
Ana María Osorio11/26/2012
-
11/26/2017
Brazil, Australia, and Canada (Multilateral)Cooperation in the Medical Device Single Audit ProgramEnglish: [HTML]
French: [HTML]
Portuguese: [HTML]
Katherine Cooper
 
11/17/2012
In effect indefinitely
BelgiumDry Milk Products[HTML]Angela Byrod 
11/6/1974
In effect indefinitely
Canada, Australia, and Brazil (Multilateral)Cooperation in the Medical Device Single Audit ProgramEnglish: [HTML]
French: [HTML]
Portuguese: [HTML]
Katherine Cooper
 
11/17/2012
In effect indefinitely
CanadaProprietary Software to Minimize Medication Errors[HTML]Sema D. Hashemi
 
12/01/2005
-
12/01/2015
CanadaSharing and Exchange of Information about Therapeutic Products[HTML]Sema D. Hashemi 12/01/2005
In effect indefinitely
CanadaFood Emergency Situations[HTML]Sema D. Hashemi
 
1/5/1998
In effect indefinitely
CanadaDrug Plan/Inspection Good Manufacturing Practices[HTML]Sema D. Hashemi
 
10/1/1973
In effect indefinitely
CanadaExchange of Information on Radiological Health Compliance Programs 

 
[HTML]Sema D. Hashemi
 
12/16/1974
In effect indefinitely
CanadaShellfish Safety[HTML]Sema D. Hashemi
 
In effect indefinitely
CanadaGood Laboratory Practices Phase I/Non-Clinical Labs[HTML]Sema D. Hashemi
 
5/10/1979
In effect indefinitely
CanadaAgricultural Trade (Veterinary Drugs and Pesticides)[HTML]Sema D. Hashemi 12/4/1998
In effect indefinitely
CanadaExchange of Information About Therapeutic Products

 
Amended:
[FDA Amendments]
[HPFB Amendments]
[MOU as Amended]
Original MOU: [Original MOU]
Sema D. Hashemi 
 
11/18/2003
-
11/18/2013
Canada and MexicoScientific and Regulatory Fields of Health: Cooperation[HTML]Katherine Cooper 
 
10/30/1995
In effect indefinitely
ChinaFood safety risk assessment, management, and communication[[Pdf 846 KB]]Katherine Cooper
 
12/11/2013
In effect Indefinitely
ChinaSafety of drugs and medical devices[HTML]Astrid L. Szeto
 
12/11/2007
-
12/11/2009
Automatically Extended to:
12/11/2013
ChinaSafety of Food and feed[HTML]Astrid L. Szeto 12/11/2007
-
12/11/2017
ChinaCeramicware intended for use in the preparation, serving or storage of food or drink and offered for export to the United States of America[HTML]Astrid L. Szeto 11/09/2010
-
11/09/2015
Costa RicaTo facilitate the exchange of information and the development of projects of mutual interest[HTML]Bruce Ross  4/15/2011
-
4/14/2016
DenmarkDry Milk Products[HTML]Angela Byrod 1/19/1979
In effect indefinitely
European Union
(EC, DG SANCO)
Food Safety[HTML]Angela Byrod  9/23/2005
In effect indefinitely
FinlandImported Food Products Certification[HTML]Angela Byrod  3/4/1984
In effect indefinitely
FranceGood Laboratory Practices Phase II/Non-Clinical Labs[HTML]Angela Byrod 3/18/1986
In effect indefinitely
FranceCaseins[HTML]Angela Byrod 1/15/1987
In effect indefinitely
FranceCheese Certification Program for Listeria[HTML]Angela Byrod  1/21/1987
In effect indefinitely
GermanyGood Laboratory Practices Phase II/Non-Clinical Labs[HTML]Angela Byrod  12/23/1988
In effect indefinitely
IcelandShellfish Safety[HTML]Angela Byrod 12/28/1978
In effect indefinitely
IndiaCooperation on Medical Products[[Pdf 2MB]]Katherine Cooper 2/10/2014
-
2/10/2019
IrelandCertification requirements for caseins, caseinates, and mixtures exported from Ireland

FDA [HTML

DAFF [HTML]

Angela Byrod 11/10/2010
-
11/10/2015
ItalyGood Laboratory Practices Phase II/Non-Clinical Labs[HTML]Angela Byrod 12/19/1989
In effect indefinitely
JapanShellfish Safety 

 
[HTML]Sema D. Hashemi 10/24/1962
In effect indefinitely
JapanGood Laboratory Practices Phase I/Non-Clinical Labs[HTML]Sema D. Hashemi 4/15/1983
In effect indefinitely
JapanPuffer Fish[HTML]Sema D. Hashemi 10/24/1988
In effect indefinitely
JapanExchange of Good Manufacturing Practices Inspection Information

1. Japan/US Letter

2. US/Japan Letter

[HTML

[HTML]

Sema D. Hashemi12/27/2000
In effect indefinitely
MexicoCooperation on the Produce Safety Partnership for Fresh and Minimally Processed ProduceEnglish [HTML]
Español [HTML]
Bruce Ross7/24/2014
In effect indefinitely
MexicoCantaloupe

NEW
FDA-SENASICA
[HTML] English 
[HTML] Español  

 

Extended
FDA-SENASICA
English [HTML]
Español [HTML]
 

Extended
FDA-SENASICA
English [HTML]
Español [HTML]


Extended
FDA-SENASICA
English [HTML]
Español [HTML]


Extended
FDA-SENASICA
English [HTML]
Español [HTML]



Amended 
FDA [HTML
SENASICA [HTML]



Original MOU
FDA - SENASICA [HTML]

Bruce Ross 

New

11/16/2012
-
in Effect Indefinitely

 
Extended

8/28/2012
-
11/25/2012



Extended

10/28/2011
-
4/28/2012
 

Extended

10/28/2010
-
10/28/2011

Amended

4/19/2007
-
10/26/2010

Original MOU

10/26/2005
-
10/26/2010

 

MexicoSafety and Quality of Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican Sates to the United States of America[HTML] English
[HTML] Español
Bruce Ross  6/26/2012
-
6/26/2017
MexicoCooperation to Enhance Activities of Mutual Interest in the Area of the Safety of Foods for Human Consumption[HTML] English
[HTML] Español
Bruce Ross 6/13/2012
-
6/13/2017
Mexico and CanadaScientific and Regulatory Fields of Health[HTML]Naomi Kawin 10/30/1995
In effect indefinitely
Multilateral: Australia, Brazil, and CanadaCooperation in the Medical Device Single Audit ProgramEnglish: [HTML]
French: [HTML]
Portuguese: [HTML]
Katherine Cooper11/17/2012
In effect indefinitely
NetherlandsDry Milk Products[HTML]Angela Byrod  1/8/1979
In effect indefinitely
NetherlandsGood Laboratory Practices Phase II/Non-Clinical Labs[HTML]Angela Byrod  12/20/1988
In effect indefinitely
New ZealandFood Safety Systems Recognition
 
[HTML]Sema Hashemi12/10/2012
In effect indefinitely
New ZealandShellfish Safety 

 
[HTML]Sema Hashemi10/30/1980
In effect indefinitely
New ZealandDry Milk Products[HTML]Sema Hashemi11/11/1975
In effect indefinitely
New ZealandFish and Fishery Products[HTML]Sema Hashemi 12/20/1995
In effect indefinitely
New ZealandHorticultural Produce (strawberries/kiwifruit); Pesticides[HTML]Sema Hashemi 3/13/1995
In effect indefinitely
NorwayRennet Casein[HTML]Angela Byrod  2/26/1982
In effect indefinitely
NorwaySmoked Salmon[HTML]Angela Byrod  10/15/1996
PhilippinesFood Products[HTML]Sema D. Hashemi 9/18/1986
In effect indefinitely
RussiaFood Products 

 
[HTML]Angela Byrod  3/29/1996
In effect indefinitely
RussiaDrug Products, Good Clinical Practices[HTML](English)
[HTML] (Russian)
Angela Byrod  05/27/2010
In effect indefinitely
SingaporeMedical Products[HTML]Sema D. Hashemi 6/24/2005
-
6/24/2010
SpainClementines[HTML]Angela Byrod  9/27/2000
In effect indefinitely
SwedenDry Milk Products[HTML]Angela Byrod  11/2/1977
In effect indefinitely
SwedenGood Laboratory Practices Phase I/Non-Clinical Labs[HTML]Angela Byrod  5/25/1979
In effect indefinitely
SwedenDrug Plant Inspections Good Manufacturing Practices; Exchange of Information [subject matter is covered by the U.S.-EU Pharmaceuticals Good Manufacturing Practices Annex][HTML]Angela Byrod  10/17/1972
In effect indefinitely
SwitzerlandDrug Plant Inspections[HTML]Angela Byrod  10/28/1968
In effect indefinitely
SwitzerlandGood Laboratory Practices Phase II/Non-Clinical Labs[HTML]Angela Byrod  4/29/1985
In effect indefinitely
SwitzerlandDrug Plant Inspections; Regulatory Cooperation (Agreed Minutes) 

 
[HTML]Angela Byrod  8/7/1998
In effect indefinitely
SwitzerlandExchange of information about pharmaceutical products for human and animal use, and medical devices[HTML]Angela Byrod  09/22/2003
-
09/22/2013
Taiwan (Taipei)Medical Device Inspections 

 
[HTML]Astrid L. Szeto 1/9/1998
In effect indefinitely
United KingdomShellfish Safety[HTML]Angela Byrod  9/7/1982
In effect indefinitely
United KingdomMedical Device Inspection of Manufacturers[HTML]Angela Byrod  6/6/1986
In effect indefinitely

For additional information about the International Arrangements listed above, please contact Marie Mbaye at Marie.Mbaye@fda.hhs.gov or (301) 796 4600

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Page Last Updated: 08/01/2014
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