Memoranda of Understanding and Other Cooperative Arrangements

COUNTRY	SUBJECT	LINKS	CONTACT	DATES Effective/Expiration
Australia, Brazil, and Canada (Multilateral)	Cooperation in the Medical Device Single Audit Program	English: [HTML] French: [HTML] Portuguese: [HTML]	Katherine Cooper	11/17/2012 In effect indefinitely
Australia	Pharmaceutical Good Manufacturing Practice Inspections	[HTML]	Sema Hashemi	10/11/2000 In effect indefinitely
Australia	Dry Milk Products	[HTML]	Sema Hashemi	11/28/1979  In effect Indefinitely
Australia	Shellfish Safety	[HTML]	Sema Hashemi	9/12/1986 In effect indefinitely
Australia	Animal Pharmaceuticals Exchange of Information	[HTML]	Sema Hashemi	2/18/1997 In effect indefinitely
Australia	Medical Device Good Manufacturing Practices Inspection Information	[HTML]	Sema Hashemi	2/17/1993 In effect indefinitely
Australia	Orphan Products	[HTML]	Sema Hashemi	8/13/1997 In effect indefinitely
Brazil	Cooperation to Enhance Activities of Mutual Interest	English [HTML] Portuguese [HTML]	Ana María Osorio	11/26/2012 - 11/26/2017
Brazil, Australia, and Canada (Multilateral)	Cooperation in the Medical Device Single Audit Program	English: [HTML] French: [HTML] Portuguese: [HTML]	Katherine Cooper	11/17/2012 In effect indefinitely
Belgium	Dry Milk Products	[HTML]	Shena Arellano	11/6/1974 In effect indefinitely
Canada, Australia, and Brazil (Multilateral)	Cooperation in the Medical Device Single Audit Program	English: [HTML] French: [HTML] Portuguese: [HTML]	Katherine Cooper	11/17/2012 In effect indefinitely
Canada	Proprietary Software to Minimize Medication Errors	[HTML]	Sema D. Hashemi	12/01/2005 - 12/01/2015
Canada	Sharing and Exchange of Information about Therapeutic Products	[HTML]	Sema D. Hashemi	12/01/2005 In effect indefinitely
Canada	Food Emergency Situations	[HTML]	Sema D. Hashemi	1/5/1998 In effect indefinitely
Canada	Drug Plan/Inspection Good Manufacturing Practices	[HTML]	Sema D. Hashemi	10/1/1973 In effect indefinitely
Canada	Exchange of Information on Radiological Health Compliance Programs	[HTML]	Sema D. Hashemi	12/16/1974 In effect indefinitely
Canada	Shellfish Safety	[HTML]	Sema D. Hashemi	In effect indefinitely
Canada	Good Laboratory Practices Phase I/Non-Clinical Labs	[HTML]	Sema D. Hashemi	5/10/1979 In effect indefinitely
Canada	Agricultural Trade (Veterinary Drugs and Pesticides)	[HTML]	Sema D. Hashemi	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]	Sema D. Hashemi	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: 12/11/2013
China	Safety of Food and feed	[HTML]	Astrid L. Szeto	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	[HTML]	Astrid L. Szeto	11/09/2010 - 11/09/2015
Costa Rica	To facilitate the exchange of information and the development of projects of mutual interest	[HTML]	Moises O'Neill	4/15/2011 - 4/14/2016
Denmark	Dry Milk Products	[HTML]	Shena Arellano	1/19/1979 In effect indefinitely
European Union (EC, DG SANCO)	Food Safety	[HTML]	Shena Arellano	9/23/2005 In effect indefinitely
Finland	Imported Food Products Certification	[HTML]	Shena Arellano	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]	Shena Arellano	1/15/1987 In effect indefinitely
France	Cheese Certification Program for Listeria	[HTML]	Shena Arellano	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]  DAFF [HTML]	Shena Arellano	11/10/2010 - 11/10/2015
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	NEW FDA-SENASICA [HTML] English  [HTML] Español     Extended FDA-SENASICA English [HTML] Español [HTML]   Extended FDA-SENASICA English [HTML] Español [HTML] Extended FDA-SENASICA English [HTML] Español [HTML] Extended FDA-SENASICA English [HTML] Español [HTML] Amended  FDA [HTML]  SENASICA [HTML] Original MOU FDA - SENASICA [HTML]	Phyllis Marquitz	New 11/16/2012 - in Effect Indefinitely   Extended 8/28/2012 - 11/25/2012 Extended 10/28/2011 - 4/28/2012   Extended 10/28/2010 - 10/28/2011 Amended 4/19/2007 - 10/26/2010 Original MOU 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	[HTML] English [HTML] Español	Phyllis Marquitz	6/26/2012 - 6/26/2017
Mexico	Cooperation to Enhance Activities of Mutual Interest in the Area of the Safety of Foods for Human Consumption	[HTML] English [HTML] Español	Phyllis Marquitz	6/13/2012 - 6/13/2017
Mexico and Canada	Scientific and Regulatory Fields of Health	[HTML]	Naomi Kawin	10/30/1995 In effect indefinitely
Multilateral: Australia, Brazil, and Canada	Cooperation in the Medical Device Single Audit Program	English: [HTML] French: [HTML] Portuguese: [HTML]	Katherine Cooper	11/17/2012 In effect indefinitely
Netherlands	Dry Milk Products	[HTML]	Shena Arellano	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	Food Safety Systems Recognition	[HTML]	Sema Hashemi	12/10/2012 In effect indefinitely
New Zealand	Shellfish Safety	[HTML]	Sema Hashemi	10/30/1980 In effect indefinitely
New Zealand	Dry Milk Products	[HTML]	Sema Hashemi	11/11/1975 In effect indefinitely
New Zealand	Fish and Fishery Products	[HTML]	Sema Hashemi	12/20/1995 In effect indefinitely
New Zealand	Horticultural Produce (strawberries/kiwifruit); Pesticides	[HTML]	Sema Hashemi	3/13/1995 In effect indefinitely
Norway	Rennet Casein	[HTML]	Shena Arellano	2/26/1982 In effect indefinitely
Norway	Smoked Salmon	[HTML]	Shena Arellano	10/15/1996
Philippines	Food Products	[HTML]	Sema D. Hashemi	9/18/1986 In effect indefinitely
Russia	Food Products	[HTML]	Shena Arellano	3/29/1996 In effect indefinitely
Russia	Drug Products, Good Clinical Practices	[HTML](English) [HTML] (Russian)	Shena Arellano	05/27/2010 In effect indefinitely
Singapore	Medical Products	[HTML]	Sema D. Hashemi	6/24/2005 - 6/24/2010
Spain	Clementines	[HTML]	Shena Arellano	9/27/2000 In effect indefinitely
Sweden	Dry Milk Products	[HTML]	Shena Arellano	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]	Shena Arellano	10/28/1968 In effect indefinitely
Switzerland	Good Laboratory Practices Phase II/Non-Clinical Labs	[HTML]	Shena Arellano	4/29/1985 In effect indefinitely
Switzerland	Drug Plant Inspections; Regulatory Cooperation (Agreed Minutes)	[HTML]	Shena Arellano	8/7/1998 In effect indefinitely
Switzerland	Exchange of information about pharmaceutical products for human and animal use, and medical devices	[HTML]	Shena Arellano	09/22/2003 - 09/22/2013
Taiwan (Taipei)	Medical Device Inspections	[HTML]	Astrid L. Szeto	1/9/1998 In effect indefinitely
United Kingdom	Shellfish Safety	[HTML]	Shena Arellano	9/7/1982 In effect indefinitely
United Kingdom	Medical Device Inspection of Manufacturers	[HTML]	Shena Arellano	6/6/1986 In effect indefinitely

For additional information about the International Arrangements listed above, please contact Marie Mbaye at Marie.Mbaye@fda.hhs.gov or (301) 796 4600