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  1. International Arrangements

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.

Narrow results by:

COUNTRY/ORGANIZATION SUBJECT EFFECTIVE DATE EXPIRATION DATE
Mexico  Safety and Sanitary Quality of Refrigerated Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican States to the United States of America

Español
11/01/2018 11/1/2023
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 Food Safety Systems Recognition 04/18/2017 Indefinite
Australia Pharmaceutical Good Manufacturing Practice Inspections 10/11/2000 Indefinite
Australia Animal Pharmaceuticals Exchange of Information 02/18/1997 Indefinite
Australia Orphan Products 08/13/1997 Indefinite
Australia Medical Device Good Manufacturing Practices Inspection Information 02/17/1993 Indefinite
Australia Shellfish Safety 09/12/1986 Indefinite
Australia Dry Milk Products 11/28/1979 Indefinite
Brazil

Cooperation to Enhance Activities of Mutual Interest

Portuguese

11/26/2012 11/26/2017
Belgium Dry Milk Products 11/06/1974 Indefinite
Canada Sharing Information And Facilitation of Collaborative Research Projects
FDA/CFIA
CFIA/FDA
10/18/2017 10/18/2022
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

Registration of U.S. Food Manufacturers Exporting to China
FDA-CFDA MOU English (Pdf 2.96MB]
CNCA FDA MOU-Chinese (HTML)
CNCA-FDA MOU Chinese [Pdf 2.77MB]

6/15/2017 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
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
Inter-American Institute for Cooperation on Agriculture To facilitate the exchange of information and the development of projects of mutual interest 04/15/2011 04/14/2016
Ireland Certification requirements for caseins, caseinates, and mixtures exported from Ireland

FDA

DAFM

08/25/2016 08/25/2021
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
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  
PAHO

Regulatory Exchange Platform (MDSAP)

Amendment No 1 (PDF 24KB)

05/05/2016
 

07/30/2019

Indefinite
 

Indefinite

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 additional information about Cooperative Arrangements, contact OC-OGPS-IA@fda.hhs.gov.

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