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International Programs
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Memoranda of Understanding and Other Cooperative Arrangements
| COUNTRY | SUBJECT | LINKS | CONTACT | DATES Effective/Expiration |
|---|---|---|---|---|
| Australia | Regulation of Animal Drugs | APVMA [HTML] | Michael J. Airumian |
10/20/2005 - 10/20/2010 |
| Australia | Pharmaceutical Good Manufacturing Practice Inspections |
[HTML] | Michael J. Airumian |
10/11/2000 In effect indefinitely |
| Australia | Dry Milk Products |
[HTML] | Michael J. Airumian |
11/28/1979 In effect Indefinitely |
| Australia | Shellfish Safety |
[HTML] | Michael J. Airumian |
9/12/1986 In effect indefinitely |
| Australia | Animal Pharmaceuticals Exchange of Information |
[HTML] | Michael J. Airumian |
2/18/1997 In effect indefinitely |
| Australia | Medical Device Good Manufacturing Practices Inspection Information |
[HTML] | Michael J. Airumian |
2/17/1993 In effect indefinitely |
| Australia | Orphan Products | [HTML] | Michael J. Airumian |
8/13/1997 In effect indefinitely |
| Belgium | Dry Milk Products | [HTML] | David P. Kelly |
11/6/1974 In effect indefinitely |
| Canada | Proprietary Software to Minimize Medication Errors | [HTML] | Charles A. Gaylord |
12/01/2005 - 12/01/2015 |
| Canada | Sharing and Exchange of Information about Therapeutic Products | [HTML] | Charles A. Gaylord |
12/01/2005 In effect indefinitely |
| Canada | Food Emergency Situations | [HTML] | Charles A. Gaylord |
1/5/1998 In effect indefinitely |
| Canada | Drug Plan/Inspection Good Manufacturing Practices | [HTML] | Charles A. Gaylord |
10/1/1973 In effect indefinitely |
| Canada | Exchange of Information on Radiological Health Compliance Programs |
[HTML] | Charles A. Gaylord | 12/16/1974 In effect indefinitely |
| Canada | Shellfish Safety | [HTML] | Charles A. Gaylord |
In effect indefinitely |
| Canada | Good Laboratory Practices Phase I/Non-Clinical Labs | [HTML] | Charles A. Gaylord |
5/10/1979 In effect indefinitely |
| Canada | Agricultural Trade (Veterinary Drugs and Pesticides) | [HTML] | Charles A. Gaylord |
12/4/1998 In effect indefinitely |
| Canada | Exchange of Information About Therapeutic Products |
Amended: [FDA Amendments] [HPFB Amendments] [MOU as Amended] Original MOU: [Original MOU] |
Charles A. Gaylord |
11/18/2003 - 11/18/2013 |
| Canada and Mexico | Scientific and Regulatory Fields of Health: Cooperation | [HTML] | Sheri L. Schwartzback |
10/30/1995 In effect indefinitely |
| China | Safety of drugs and medical devices | [HTML] | Astrid L. Szeto |
12/11/2007 - 12/11/2009 Automatically Extended to: 12/11/2011 |
| China | Safety of Food and feed | [HTML] | Adam W. Tewell |
12/11/2007 - 12/11/2012 |
| 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 | [HTML] | Astrid L. Szeto |
1/06/2006 [Last signature date of the Chinese version MOU] - 1/06/2011 |
| Denmark | Dry Milk Products | [HTML] | David P. Kelly |
1/19/1979 In effect indefinitely |
| European Union (EC, DG SANCO) |
Food Safety | [HTML] | David P. Kelly |
9/23/2005 In effect indefinitely |
| Finland | Imported Food Products Certification | [HTML] | David P. Kelly |
3/4/1984 In effect indefinitely |
| France | Good Laboratory Practices Phase II/Non-Clinical Labs | [HTML] | Shena Arellano |
3/18/1986 In effect indefinitely |
| France | Caseins | [HTML] | David P. Kelly |
1/15/1987 In effect indefinitely |
| France | Cheese Certification Program for Listeria | [HTML] | David P. Kelly |
1/21/1987 In effect indefinitely |
| Germany | Good Laboratory Practices Phase II/Non-Clinical Labs | [HTML] | Shena Arellano |
12/23/1988 In effect indefinitely |
| Iceland | Shellfish Safety | [HTML] | Shena Arellano |
12/28/1978 In effect indefinitely |
| Ireland | Certification requirements for caseins, caseinates, and mixtures exported from Ireland |
FDA [HTML] DAF [HTML] |
David P. Kelly |
6/29/2007 - 6/29/2012 |
| Italy | Good Laboratory Practices Phase II/Non-Clinical Labs | [HTML] | Shena Arellano |
12/19/1989 In effect indefinitely |
| Japan | Shellfish Safety |
[HTML] | Sema D. Hashemi |
10/24/1962 In effect indefinitely |
| Japan | Good Laboratory Practices Phase I/Non-Clinical Labs | [HTML] | Sema D. Hashemi |
4/15/1983 In effect indefinitely |
| Japan | Puffer Fish | [HTML] | Sema D. Hashemi |
10/24/1988 In effect indefinitely |
| Japan | Exchange of Good Manufacturing Practices Inspection Information 1. Japan/US Letter 2. US/Japan Letter |
[HTML] [HTML] |
Sema D. Hashemi |
12/27/2000 In effect indefinitely |
| Mexico | Cantaloupe |
Amended FDA [HTML] SAGARPA [HTML] MOU [HTML] |
Naomi Kawin |
4/19/2007 - 4/19/2012 |
| Mexico | Safety and Quality of Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican Sates to the United States of America | Extended [HTML] MOU [HTML] Spanish Version[HTML] | Naomi Kawin |
6/18/2008 - 6/18/2013 |
| Mexico | Cooperation to Enhance Activities of Mutual Interest in the Area of the Safety of Foods for Human Consumption | [HTML] | Naomi Kawin |
9/4/2001 - 9/4/2011 |
| Mexico and Canada | Scientific and Regulatory Fields of Health | [HTML] | Naomi Kawin |
10/30/1995 In effect indefinitely |
| Netherlands | Dry Milk Products | [HTML] | David P. Kelly |
1/8/1979 In effect indefinitely |
| Netherlands | Good Laboratory Practices Phase II/Non-Clinical Labs | [HTML] | Shena Arellano |
12/20/1988 In effect indefinitely |
| New Zealand | Shellfish Safety |
[HTML] | Michael J. Airumian |
10/30/1980 In effect indefinitely |
| New Zealand | Dry Milk Products | [HTML] | Michael J. Airumian |
11/11/1975 In effect indefinitely |
| New Zealand | Fish and Fishery Products | [HTML] | Michael J. Airumian |
12/20/1995 In effect indefinitely |
| New Zealand | Horticultural Produce (strawberries/kiwifruit); Pesticides | [HTML] | Michael J. Airumian |
3/13/1995 In effect indefinitely |
| New Zealand | Cooperation to enhance activities of mutual interest in the area of the safety and defense of foods for human consumption and animal feeds |
Amended (Exchange of letters) FDA [HTML] NZFSA [HTML] MOU[HTML] |
Michael J. Airumian |
3/18/2005 - 3/17/2010 |
| Norway | Rennet Casein | [HTML] | David P. Kelly |
2/26/1982 In effect indefinitely |
| Norway | Smoked Salmon | [HTML] | David P. Kelly |
10/15/1996 |
| Philippines | Food Products | [HTML] | Sema D. Hashemi |
9/18/1986 In effect indefinitely |
| Russia | Food Products |
[HTML] | David P. Kelly |
3/29/1996 In effect indefinitely |
| Singapore | Medical Products | [HTML] | Matthew E. Eckel |
6/24/2005 - 6/24/2010 |
| Spain | Clementines | [HTML] | David P. Kelly |
9/27/2000 In effect indefinitely |
| Sweden | Dry Milk Products | [HTML] | David P. Kelly |
11/2/1977 In effect indefinitely |
| Sweden | Good Laboratory Practices Phase I/Non-Clinical Labs | [HTML] | Shena Arellano |
5/25/1979 In effect indefinitely |
| Sweden | Drug Plant Inspections Good Manufacturing Practices; Exchange of Information [subject matter is covered by the U.S.-EU Pharmaceuticals Good Manufacturing Practices Annex] | [HTML] | Shena Arellano | 10/17/1972 In effect indefinitely |
| Switzerland | Drug Plant Inspections | [HTML] | David P. Kelly | 10/28/1968 In effect indefinitely |
| Switzerland | Good Laboratory Practices Phase II/Non-Clinical Labs | [HTML] | David P. Kelly | 4/29/1985 In effect indefinitely |
| Switzerland | Drug Plant Inspections; Regulatory Cooperation (Agreed Minutes) |
[HTML] | David P. Kelly | 8/7/1998 In effect indefinitely |
| Switzerland | Exchange of information about pharmaceutical products for human and animal use, and medical devices | [HTML] | David P. Kelly |
09/22/2003 - 09/22/2013 |
| Taiwan (Taipei) | Medical Device Inspections |
[HTML] | Astrid L. Szeto |
1/9/1998 In effect indefinitely |
| Trilateral Cooperation Mexico, Canada, and United States |
Trilateral Cooperation Charter to increase communication, collaboration, and exchange of information in the areas of drugs, biologic, medical devices, food safety, and nutrition |
[HTML] (English) HTML] (French) HTML] (Spanish) |
Sheri L. Schwartzback |
10/14/2009 In effect indefinitely |
| United Kingdom | Food Safety Analytical Methods | [HTML] | David P. Kelly |
10/29/03 - 10/29/08 |
| United Kingdom | Shellfish Safety | [HTML] | David P. Kelly |
9/7/1982 In effect indefinitely |
| United Kingdom | Medical Device Inspection of Manufacturers | [HTML] | David P. Kelly |
6/6/1986 In effect indefinitely |
| Vietnam | Food, animal, feed, and medical product safety | [HTML] | Russell C. Campbell | 06/28/2008 - 06/28/2011 |
For additional information about the International Arrangements listed above, please contact Marie Mbaye at Marie.Mbaye@fda.hhs.gov or (301) 827 4480
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