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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COUNTRY SUBJECT EFFECTIVE DATE EXPIRATION DATE
Canada

Food Safety Systems Recognition

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

Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012 Indefinite
Australia Pharmaceutical Good Manufacturing Practice Inspections 10/11/2000 Indefinite
Australia Dry Milk Products 11/28/1979 Indefinite
Australia Shellfish Safety 09/12/1986 Indefinite
Australia Animal Pharmaceuticals Exchange of Information 02/18/1997 Indefinite
Australia Medical Device Good Manufacturing Practices Inspection Information 02/17/1993 Indefinite
Australia Orphan Products 08/13/1997 Indefinite
Brazil

Cooperation to Enhance Activities of Mutual Interest

Portuguese

11/26/2012 11/26/2017
Brazil, Australia, and Canada (Multilateral)

Cooperation in the Medical Device Single Audit Program

French
Portuguese

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

French
Portuguese

11/17/2012 Indefinite
Canada Proprietary Software to Minimize Medication Errors 12/01/2005 12/01/2015
Canada Sharing and Exchange of Information about Therapeutic Products 12/01/2005 Indefinite
Canada Food Emergency Situations 01/05/1998 Indefinite
Canada Drug Plan/Inspection Good Manufacturing Practices 10/01/1973 Indefinite
Canada Exchange of Information on Radiological Health Compliance Programs 12/16/1974 Indefinite
Canada Shellfish Safety 04/30/1948 Indefinite
Canada Good Laboratory Practices Phase I/Non-Clinical Labs 05/10/1979 Indefinite
Canada Agricultural Trade (Veterinary Drugs and Pesticides) 12/04/1998 Indefinite
Canada

Exchange of Information About Therapeutic Products

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

Original MOU

11/18/2003 11/18/2013
Canada and Mexico Scientific and Regulatory Fields of Health: Cooperation 10/30/1995 Indefinite
China

Implementing Arrangements:
CFDA
AQSIQ

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

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

11/21/2014 12/16/2014
China Food safety risk assessment, management, and communication [Pdf 846 KB] 12/11/2013 Indefinite
China Safety of drugs and medical devices 12/11/2007 12/11/2009
Automatically Extended to:
12/11/2013
China Safety of Food and feed 12/11/2007 12/11/2017
China Ceramicware intended for use in the preparation, serving or storage of food or drink and offered for export to the United States of America 11/09/2010 11/09/2015
Costa Rica To facilitate the exchange of information and the development of projects of mutual interest 04/15/2011 04/14/2016
Denmark Dry Milk Products 01/19/1979 Indefinite
European Union
(EC, DG SANCO)
Food Safety 09/23/2005 Indefinite
Finland Imported Food Products Certification 03/04/1984 Indefinite
France Law Enforcement Cooperation

French

12/02/2014 Indefinite
France Good Laboratory Practices Phase II/Non-Clinical Labs 03/18/1986 Indefinite
France Caseins 01/15/1987 Indefinite
France Cheese Certification Program for Listeria 01/21/1987 Indefinite
Germany Good Laboratory Practices Phase II/Non-Clinical Labs 12/23/1988 Indefinite
Iceland Shellfish Safety 12/28/1978 Indefinite
India Cooperation on Medical Products [Pdf 2MB] 02/10/2014 02/10/2019
India Food Safety [Pdf 901 KB]

Hindi [Pdf 935 KB]

03/23/2015 03/23/2020
Ireland Certification requirements for caseins, caseinates, and mixtures exported from Ireland

FDA

DAFF

11/10/2010 11/10/2015
Italy Laboratory Practices Phase II/Non-Clinical Labs 12/19/1989 Indefinite
Japan Shellfish Safety 10/24/1962 Indefinite
Japan Good Laboratory Practices Phase I/Non-Clinical Labs 04/15/1983 Indefinite
Japan Puffer Fish 10/24/1988 Indefinite
Japan

Exchange of Good Manufacturing Practices Inspection Information

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

12/27/2000 Indefinite
Korea Fresh and Fresh Frozen Molluscan Shellfish 06/15/2015 06/15/2020
Mexico

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

Español

07/24/2014 Indefinite
Mexico

Cantaloupe

NEW

FDA-SENASICA
Español

11/16/2012 Indefinite
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

08/28/2012 11/25/2012
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

04/30/2012 Indefinite
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

10/28/2011 04/28/2012
Mexico

Cantaloupe

Extended

FDA-SENASICA
Español

10/28/2010 10/28/2011
Mexico

Cantaloupe

Amended

FDA
SENASICA

04/19/2007 10/26/2010
Mexico

Cantaloupe

Original MOU

FDA - SENASICA

10/26/2005 10/26/2010
Mexico

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

Español

06/26/2012 06/26/2017
Mexico

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

Español

06/13/2012 06/13/2017
Mexico and Canada Scientific and Regulatory Fields of Health 10/30/1995 Indefinite
Multilateral: Australia, Brazil, and Canada

Cooperation in the Medical Device Single Audit Program

French
Portuguese

11/17/2012 Indefinite
Netherlands Dry Milk Products 01/08/1979 Indefinite
Netherlands Good Laboratory Practices Phase II/Non-Clinical Labs 12/20/1988 Indefinite
New Zealand Food Safety Systems Recognition 12/10/2012 Indefinite
New Zealand Horticultural Produce (strawberries/kiwifruit); Pesticides 03/13/1995 Indefinite
New Zealand Safety and Defense of Foods for Human Consumption and Animal Feeds 09/30/2015 Indefinite
Norway Rennet Casein 02/26/1982 Indefinite
Norway Smoked Salmon 10/15/1996  
Philippines Food Products 09/18/1986 Indefinite
Russia Food Products 03/29/1996 Indefinite
Russia

Drug Products, Good Clinical Practices

Russian

05/27/2010 Indefinite
Singapore Medical Products 06/24/2005 06/24/2010
Spain Clementines 09/27/2000 Indefinite
Sweden Dry Milk Products 11/02/1977 Indefinite
Sweden Good Laboratory Practices Phase I/Non-Clinical Labs 05/25/1979 Indefinite
Sweden Drug Plant Inspections Good Manufacturing Practices; Exchange of Information [subject matter is covered by the U.S.-EU Pharmaceuticals Good Manufacturing Practices Annex] 10/17/1972 Indefinite
Switzerland Drug Plant Inspections 10/28/1968 Indefinite
Switzerland Good Laboratory Practices Phase II/Non-Clinical Labs 04/29/1985 Indefinite
Switzerland Drug Plant Inspections; Regulatory Cooperation (Agreed Minutes) 08/07/1998 Indefinite
Switzerland Exchange of information about pharmaceutical products for human and animal use, and medical devices 09/22/2003 09/22/2013
Taiwan (Taipei) Medical Device Inspections 01/09/1998 Indefinite
United Kingdom Shellfish Safety 09/07/1982 Indefinite
United Kingdom Medical Device Inspection of Manufacturers 06/06/1986 Indefinite
 

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

Page Last Updated: 05/04/2016
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