International Programs

Cooperative Arrangements

A Cooperative Arrangement is a written understanding that FDA can establish with one or more foreign governments or international partners that describes the willingness and good-faith intentions of FDA and its counterpart(s) to engage in cooperative activities. Cooperative Arrangements can have a variety of titles, including "Memorandum of Understanding."

Even with a Cooperative Arrangement in place, the FDA cannot share non-public information unless a Confidentiality Commitment exists.

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COUNTRYSUBJECTEFFECTIVE DATEEXPIRATION DATE
Canada

Food Safety Systems Recognition

05/04/2016Indefinite
Australia, Brazil, and Canada (Multilateral)

Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012Indefinite
AustraliaPharmaceutical Good Manufacturing Practice Inspections10/11/2000Indefinite
AustraliaDry Milk Products11/28/1979Indefinite
AustraliaShellfish Safety09/12/1986Indefinite
AustraliaAnimal Pharmaceuticals Exchange of Information02/18/1997Indefinite
AustraliaMedical Device Good Manufacturing Practices Inspection Information02/17/1993Indefinite
AustraliaOrphan Products08/13/1997Indefinite
Brazil

Cooperation to Enhance Activities of Mutual Interest

Portuguese

11/26/201211/26/2017
Brazil, Australia, and Canada (Multilateral)

Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012Indefinite
BelgiumDry Milk Products11/06/1974Indefinite
Canada, Australia, and Brazil (Multilateral)Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012Indefinite
CanadaProprietary Software to Minimize Medication Errors12/01/200512/01/2015
CanadaSharing and Exchange of Information about Therapeutic Products12/01/2005Indefinite
CanadaFood Emergency Situations01/05/1998Indefinite
CanadaDrug Plan/Inspection Good Manufacturing Practices10/01/1973Indefinite
CanadaExchange of Information on Radiological Health Compliance Programs12/16/1974Indefinite
CanadaShellfish Safety04/30/1948Indefinite
CanadaGood Laboratory Practices Phase I/Non-Clinical Labs05/10/1979Indefinite
CanadaAgricultural Trade (Veterinary Drugs and Pesticides)12/04/1998Indefinite
Canada

Exchange of Information About Therapeutic Products

Amended:
[FDA Amendments]
[HPFB Amendments]
[MOU as Amended]

Original MOU

11/18/200311/18/2013
Canada and MexicoScientific and Regulatory Fields of Health: Cooperation10/30/1995Indefinite
China

Implementing Arrangements:
CFDA
AQSIQ

FDA-CFDA [Pdf 846 KB]
Chinese [Pdf 861 KB]

FDA-AQSIQ [Pdf 351 KB]
Chinese [Pdf 474 KB]

11/21/201412/16/2014
ChinaFood safety risk assessment, management, and communication [Pdf 846 KB]12/11/2013Indefinite
ChinaSafety of drugs and medical devices12/11/200712/11/2009
Automatically Extended to:
12/11/2013
ChinaSafety of Food and feed12/11/200712/11/2017
ChinaCeramicware intended for use in the preparation, serving or storage of food or drink and offered for export to the United States of America11/09/201011/09/2015
Costa RicaTo facilitate the exchange of information and the development of projects of mutual interest04/15/201104/14/2016
DenmarkDry Milk Products01/19/1979Indefinite
European Union
(EC, DG SANCO)
Food Safety09/23/2005Indefinite
FinlandImported Food Products Certification03/04/1984Indefinite
FranceLaw Enforcement Cooperation

French

12/02/2014Indefinite
FranceGood Laboratory Practices Phase II/Non-Clinical Labs03/18/1986Indefinite
FranceCaseins01/15/1987Indefinite
FranceCheese Certification Program for Listeria01/21/1987Indefinite
GermanyGood Laboratory Practices Phase II/Non-Clinical Labs12/23/1988Indefinite
IcelandShellfish Safety12/28/1978Indefinite
IndiaCooperation on Medical Products [Pdf 2MB]02/10/201402/10/2019
IndiaFood Safety [Pdf 901 KB]

Hindi [Pdf 935 KB]

03/23/201503/23/2020
IrelandCertification requirements for caseins, caseinates, and mixtures exported from Ireland

FDA

DAFM

08/25/201608/25/2021
ItalyLaboratory Practices Phase II/Non-Clinical Labs12/19/1989Indefinite
JapanShellfish Safety10/24/1962Indefinite
JapanGood Laboratory Practices Phase I/Non-Clinical Labs04/15/1983Indefinite
JapanPuffer Fish10/24/1988Indefinite
Japan

Exchange of Good Manufacturing Practices Inspection Information

1. Japan/US Letter
2. US/Japan Letter

12/27/2000Indefinite
KoreaFresh and Fresh Frozen Molluscan Shellfish06/15/201506/15/2020
Mexico

Cooperation on the Produce Safety Partnership for Fresh and Minimally Processed Produce

Español

07/24/2014Indefinite
Mexico

Cantaloupe

NEW

FDA-SENASICA
Español

11/16/2012Indefinite
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

08/28/201211/25/2012
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

04/30/2012Indefinite
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

10/28/201104/28/2012
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

10/28/201010/28/2011
Mexico

Cantaloupe

Amended

FDA
SENASICA

04/19/200710/26/2010
Mexico

Cantaloupe

Original MOU

FDA - SENASICA

10/26/200510/26/2010
Mexico

Safety and Quality of Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican Sates to the United States of America

Español

06/26/201206/26/2017
Mexico

Cooperation to Enhance Activities of Mutual Interest in the Area of the Safety of Foods for Human Consumption

Español

06/13/201206/13/2017
Mexico and CanadaScientific and Regulatory Fields of Health10/30/1995Indefinite
Multilateral: Australia, Brazil, and Canada

Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012Indefinite
NetherlandsDry Milk Products01/08/1979Indefinite
NetherlandsGood Laboratory Practices Phase II/Non-Clinical Labs12/20/1988Indefinite
New ZealandFood Safety Systems Recognition12/10/2012Indefinite
New ZealandHorticultural Produce (strawberries/kiwifruit); Pesticides03/13/1995Indefinite
New ZealandSafety and Defense of Foods for Human Consumption and Animal Feeds09/30/2015Indefinite
NorwayRennet Casein02/26/1982Indefinite
NorwaySmoked Salmon10/15/1996 
PAHORegulatory Exchange Platform05/05/2016Indefinite
PhilippinesFood Products09/18/1986Indefinite
RussiaFood Products03/29/1996Indefinite
Russia

Drug Products, Good Clinical Practices

Russian

05/27/2010Indefinite
SingaporeMedical Products06/24/200506/24/2010
SpainClementines09/27/2000Indefinite
SwedenDry Milk Products11/02/1977Indefinite
SwedenGood Laboratory Practices Phase I/Non-Clinical Labs05/25/1979Indefinite
SwedenDrug Plant Inspections Good Manufacturing Practices; Exchange of Information [subject matter is covered by the U.S.-EU Pharmaceuticals Good Manufacturing Practices Annex]10/17/1972Indefinite
SwitzerlandDrug Plant Inspections10/28/1968Indefinite
SwitzerlandGood Laboratory Practices Phase II/Non-Clinical Labs04/29/1985Indefinite
SwitzerlandDrug Plant Inspections; Regulatory Cooperation (Agreed Minutes)08/07/1998Indefinite
SwitzerlandExchange of information about pharmaceutical products for human and animal use, and medical devices09/22/200309/22/2013
Taiwan (Taipei)Medical Device Inspections01/09/1998Indefinite
United KingdomShellfish Safety09/07/1982Indefinite
United KingdomMedical Device Inspection of Manufacturers06/06/1986Indefinite
 

For addtional information about the International Arrangements, contact OC-OIP-IAD@fda.hhs.gov.

Page Last Updated: 09/16/2016
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