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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 

 

Extended

Español

 

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

 

11/01/2023

 

11/01/2018

 

 

11/01/2028

 

11/1/2023

 

 

European Union (DG SANTE) Shellfish Safety 07/31/2020 Indefinite
India Medical Products Safety
FDA/CDSCO (Hindi) [Pdf 1.8MB]
CDSCO/FDA (Hindi) [Pdf 1.7MB]
02/24/2020 Indefinite
Mexico  Food Safety Partnership

Español
09/29/2020 Indefinite
Canada

Food Safety Systems Recognition

04/25/2016 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 - Update on Australian regulatory agencies 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

Statement of Cooperation to Enhance Activities of Mutual Interest

Portuguese

12/21/2021 12/21/2026
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 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 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 Automatically renews every 5 years
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 Automatically renews every 2 years
China Safety of Food and feed 12/11/2007 Automatically renews every 5 years
Denmark Dry Milk Products 01/19/1979 Indefinite
Ecuador

Shrimp Safety

Español

08/24/2023 08/24/2028
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
Germany Sharing of Information and Facilitation of Collaborative Research Projects 08/31/2021 08/31/2026
Iceland Shellfish Safety 12/28/1978 Indefinite
Ireland

Certification requirements for caseins, caseinates, and mixtures exported from Ireland

FDA

DAFM

07/01/2022 07/01/2027
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

Japan/US Letter
US/Japan Letter

12/27/2000 Indefinite
Korea

Fresh and Fresh Frozen Molluscan Shellfish

Extended

Extended

06/15/2015

06/15/2020

06/15/2023

06/15/2020

06/15/2023

06/15/2028

Mexico

Cantaloupe

NEW

FDA-SENASICA
Español

11/16/2012 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 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
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 Good Laboratory Practices Phase II/Non-Clinical Labs 04/29/1985 Indefinite
Switzerland Drug Plant Inspections; Regulatory Cooperation (Agreed Minutes) 08/07/1998 Indefinite
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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