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The referenced International Arrangements documents are in Adobe Acrobat PDF format. To download the latest version of the free Adobe Acrobat Reader, please click here. |
COUNTRY |
SUBJECT |
LINKS |
CONTACT |
DATES Effective/Expiration |
|---|---|---|---|---|
| Australia | Regulation of Animal Drugs | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/20/2005 - 10/20/2010 |
|
| Australia | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/20/2005 In effect indefinitely |
|
| Australia | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
08/11/2004 In effect indefinitely |
|
| Australia | Pharmaceutical Good Manufacturing Practice Inspections |
Joseph Famulare (301) 827-8940 Joseph.Famulare@fda.hhs.gov |
10/11/2000 |
|
| Australia | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
11/28/1979 | |
| Australia | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
9/12/1986 | |
| Australia | Animal Pharmaceuticals Exchange of Information |
Merton Smith (240) 276-9025 Merton.Smith@fda.hhs.gov |
2/18/1997 | |
| Australia | Medical Device Good Manufacturing Practices Inspection Information |
Lillian Gill (301) 827-7975 Lillian.Gill@fda.hhs.gov |
2/17/1993 | |
| Australia | Orphan Products |
Marlene Haffner ( 301) 827-3666 Marlene.Haffner@fda.hhs.gov |
8/13/1997 | |
| Australia | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
03/17/2009 In effect indefinitely |
|
| Australia/New Zealand | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
04/15/2008 In effect indefinitely |
|
| Belgium | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
11/6/1974 | |
| Belgium | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/15/2004 In effect indefinitely |
|
| Belgium | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
04/23/2007 In effect indefinitely |
|
| Canada | Proprietary Software to Minimize Medication Errors | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/01/2005 - 12/01/2015 |
|
| Canada | Sharing and Exchange of Information about Therapeutic Products | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/01/2005 In effect indefinitely |
|
| Canada | Food Emergency Situations |
Ellen Morrison (301) 827-5660 Ellen.Morrison@fda.hhs.gov |
1/5/1998 | |
| Canada | Drug Plan/Inspection Good Manufacturing Practices |
Joseph Famulare (301) 827-8940 Joseph.Famulare@fda.hhs.gov |
10/1/1973 | |
| Canada | Exchange of Information on Radiological Health Compliance Programs |
John Stigi (301) 443-0806 John.Stigi@fda.hhs.gov |
12/16/1974 | |
| Canada | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
4/30/1948 | |
| Canada | Good Laboratory Practices Phase I/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
5/10/1979 | |
| Canada | Agricultural Trade (Veterinary Drugs and Pesticides) |
Merton Smith (240) 276-9025 Merton.Smith@fda.hhs.gov |
12/4/1998 | |
| Canada | Exchange of Information About Therapeutic Products |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
11/18/2003 - 11/18/2013 |
|
| Canada | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/22/2003 In effect indefinitely |
|
| Canada and Mexico | Scientific and Regulatory Fields of Health: Cooperation | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/30/1995 | |
| Canada, Mexico and United States | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
06/21/2004 In effect indefinitely |
|
| Canada | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
11/18/2003 In effect indefinitely |
|
| China | Safety of drugs and medical devices | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/11/2007 - 12/11/2009 |
|
| China | Safety of Food and feed | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
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 | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
1/06/2006 [Last signature date of the chinese version MOU] - 1/06/2011 |
|
| Denmark | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
1/19/1979 | |
| Denmark | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
11/14/2007 In effect indefinitely |
|
| European Community | A. Framework B. Pharmaceuticals Good Manufacturing Practices Annex C. Medical Device Annex |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov Joseph Famulare (301) 827-8940 Joseph.Famulare@fda.hhs.gov John Stigi (301) 443-0806 John.Stigi@fda.hhs.gov |
6/20/1997 | |
| European Community | Veterinary Equivalence Framework Agreement |
Merton Smith (240) 276-9025 Merton.Smith@fda.hhs.gov Catherine Carnevale (301) 436-2380 Catherine.Carnevale@fda.hhs.gov |
7/20/1999 | |
| European Union EC, DG Enterprise | Information Sharing related to Medical Devices | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
07/02/2007 - 07/02/2012 |
|
| European Union EC, DG Enterprise | Information Sharing related to Cosmetics | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
07/02/2007 - 07/02/2012 |
|
| European Union (EFSA) | Information Sharing related to food and feed | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
07/02/2007 In effect indefinitely |
|
| European Union (EC, DG Enterprise/EMEA) |
Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
9/12/2003 - 9/12/2005 Extended 9/15/2005 - 9/15/2010 |
|
| European Union (EC, DG SANCO) |
Food Safety | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
9/23/2005 In effect indefinitely |
|
| European Union (EC, DG SANCO) |
Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
6/6/2005 In effect indefinitely |
|
| Finland | Imported Food Products Certification |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
3/4/1984 | |
| France | Good Laboratory Practices Phase II/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
3/18/1986 | |
| France | Caseins |
[PDF] |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
1/15/1987 |
| France | Cheese Certification Program for Listeria |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
1/21/1987 | |
| France | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
2/08/2006 - 2/08/2011 |
|
| France | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
0/07/2005 In effect indefinitely |
|
| Germany | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
1/30/2006 In effect indefinitely |
|
| Germany | Good Laboratory Practices Phase II/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
12/23/1988 | |
| Germany | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
02/04/2005 In effect indefinitely |
|
| Germany | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
02/02/2005 In effect indefinitely |
|
| Iceland | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
12/28/1978 | |
| Ireland | Certification requirements for caseins, caseinates, and mixtures exported from Ireland | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
6/29/2007 - 6/29/2012 |
|
| Ireland | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
9/20/2005 In effect indefinitely |
|
| Ireland | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
06/14/2005 In effect indefinitely |
|
| Israel | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/15/2005 In effect indefinitely |
|
| Italy | Good Laboratory Practices Phase II/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
12/19/1989 | |
| Japan | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
10/24/1962 | |
| Japan | Good Laboratory Practices Phase I/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
4/15/1983 | |
| Japan | Puffer Fish |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
10/24/1988 | |
| Japan | Exchange of Good Manufacturing Practices Inspection Information 1. Japan/US Letter 2. US/Japan Letter |
Joseph Famulare (301) 827-8940 Joseph.Famulare@fda.hhs.gov |
12/27/2000 | |
| Japan | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
09/15/2004 In effect indefinitely |
|
| Japan | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
09/15/2004 In effect indefinitely |
|
| korea | Safety and Quality of Fresh and Fresh Frozen Molluscan Shellfish | [PDF608KB] |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/28/2003 - 10/28/2008 |
| Mexico | Cantaloupe | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
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 | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
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 |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
9/4/2001 - 9/4/2011 |
|
| Mexico | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
04/15/2002 In effect indefinitely |
|
| Mexico | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
5/7/2004 In effect indefinitely |
|
| Mexico and Canada | Scientific and Regulatory Fields of Health |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/30/1995 | |
| Netherlands | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
1/8/1979 | |
| Netherlands | Good Laboratory Practices Phase II/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.govv |
12/20/1988 | |
| Netherlands | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/02/2006 In effect indefinitely |
|
| New Zealand | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
10/30/1980 | |
| New Zealand | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
11/11/1975 | |
| New Zealand | Horticultural Produce (strawberries/kiwifruit); Pesticides |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
3/13/1995 | |
| New Zealand | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/28/2004 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 | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
3/18/2005 - 3/17/2010 |
|
| New Zealand | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
03/02/2007 In effect indefinitely |
|
| Norway | Rennet Casein |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
2/26/1982 | |
| Norway | Smoked Salmon |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
10/15/1996 | |
| Philippines | Food Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
9/18/1986 | |
| Russia | Food Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
3/29/1996 | |
| Singapore | Medical Products | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
6/24/2005 - 6/24/2010 |
|
| Singapore | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
8/25/2004 In effect indefinitely |
|
| South Africa | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
12/06/2004 In effect indefinitely |
|
| Spain | Clementines |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
9/27/2000 | |
| Sweden | Dry Milk Products |
Robin W. Woo (301) 436-2776 Robin.Woo@fda.hhs.gov |
11/2/1977 | |
| Sweden | Good Laboratory Practices Phase I/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
5/25/1979 | |
| Sweden | Drug Plant Inspections Good Manufacturing Practices; Exchange of Information [subject matter is covered by the U.S.-EU Pharmaceuticals Good Manufacturing Practices Annex] |
Joseph Famulare (301) 827-8940 Joseph.Famulare@fda.hhs.gov |
10/17/1972 | |
| Sweden | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
03/31/2006 In effect indefinitely |
|
| Switzerland | Drug Plant Inspections |
Steven Solomon (301) 443-6230 Steven.Solomon@fda.hhs.gov |
10/28/1968 | |
| Switzerland | Good Laboratory Practices Phase II/Non-Clinical Labs |
Lana L. Ogram (240) 632-6852 Lana.Ogram@fda.hhs.gov |
4/29/1985 | |
| Switzerland | Drug Plant Inspections; Regulatory Cooperation (Agreed Minutes) |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
8/7/1998 | |
| Switzerland | Exchange of information about pharmaceutical products for human and animal use, and medical devices | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
09/22/2003 - 09/22/2013 |
|
| Switzerland | Information sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
9/17/2003 In effect indefinitely |
|
| Taiwan (Taipei) | Medical Device Inspections |
John Stigi (301) 443-0806 John.Stigi@fda.hhs.gov |
1/9/1998 | |
| United Kingdom | Food Safety Analytical Methods | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
10/29/03 - 10/29/08 |
|
| United Kingdom | Information Sharing | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.gov |
02/14/05 In effect indefinitely |
|
| United Kingdom | Shellfish Safety |
Philip Spiller (301) 436-2300 Phillip.Spiller@fda.hhs.gov |
9/7/1982 | |
| United Kingdom | Medical Device Inspection of Manufacturers |
Lillian Gill (301) 827-7975 Lillian.Gill@fda.hhs.govov |
6/6/1986 | |
| Vietnam | Food, animal, feed, and medical product safety | [HTML] |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.go |
06/28/2008 - 06/28/2011 |
| WHO | Products Approved under PEPFAR and WHO’s Prequalification Program | Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.go |
8/11/2005 In effect indefinitely |
|
| WHO | Information sharing | [PDF300KB] |
Matthew E. Eckel (301) 827-4480 Matthew.Eckel@fda.hhs.go |
07/08/2008 In effect indefinitely |
For additional information about the International Arrangements listed above, please contact Marie Mbaye at Marie.Mbaye@fda.hhs.gov or (301) 827 4480
