Confidentiality Commitments

COUNTRY	SUBJECT	Scope	LINKS	CONTACT	DATES Effective - Expiration
Australia	Information Sharing	Cosmetics	FDA [HTML] NICNAS [HTML]	Michael J. Airumian	03/8/2011 In effect indefinitely
Australia	Information Sharing	Foods, Animal	FDA [HTML] AQIS [HTML]	Michael J. Airumian	03/17/2009 In effect indefinitely
Australia	Information Sharing	Animal & Veterinary	FDA [HTML] APMVA [HTML]	Michael J. Airumian	10/20/2005 In effect indefinitely
Australia	Information Sharing	Drugs, Biologics, Medical Devices, Radiation-Emitting Products	FDA [HTML] TGA [HTML]	Michael J. Airumian	08/11/2004 In effect indefinitely
Australia / New Zealand	Information Sharing	Foods	FDA [HTML] FSANZ [HTML]	Michael J. Airumian	04/15/2008 In effect indefinitely
Austria	Information Sharing	Drugs, Medical Devices, Animal & Veterinary	FDA [HTML] BASG [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	08/18/2009 In effect indefinitely
Brazil	Information Sharing	Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products	FDA English [HTML] Portuguese [HTML] ANVISA Portuguese [HTML] English [HTML]	Jorge Christian	09/24/2010 In effect indefinitely
Belgium	Information Sharing	Foods, Drugs, Biologics, Medical Devices	[HTML]	Shena Arellano	12/15/2004 In effect indefinitely
Belgium	Information Sharing	Drugs, Medical Devices, Animal & Veterinary	[HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	04/23/2007 In effect indefinitely
Canada	Information Sharing	Tobacco	FDA English [HTML] French [HTML] CSTD English [HTML] French [HTML]	Michael J. Airumian	1/2/2012 In effect indefinitely
Canada	Information Sharing	Biologics, Food Safety	FDA [HTML] PHAC [HTML]	Michael J. Airumian	9/28/2011 In effect indefinitely
Canada	Information Sharing	Foods	FDA [HTML] CFIA [HTML]	Michael J. Airumian	12/22/2003 In effect indefinitely
Canada	Information Sharing	Foods, Medical Devices, Animal & Veterinary Drugs, Biologics, Radiation-Emitting Products	FDA [HTML] HPFB of Health Canada [HTML]	Michael J. Airumian	11/18/2003 In effect indefinitely
Chile	Information Sharing	Foods, Drugs, Medical Device, biologics, and Cosmetics	FDA English [HTML] Spanish [HTML] ISP Spanish [HTML] English [HTML]	Edmundo Garcia	03/19/2012 In effect indefinitely
Denmark	Information sharing	Drugs and Medical Devices	FDA [HTML] DMA [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	11/14/2007 In effect indefinitely
Europe - Council of Europe	Information Sharing	Drugs, Biologics, Animal & Veterinary Products	FDA [HTML] EDQM [HTML]	Shena Arellano	05/04/2009 In effect indefinitely
European Union EC, DG Enterprise	Information Sharing related to Medical Devices	N/A, responsibilities transferred to DG SANCO	FDA [HTML] DG-Enterprise [HTML]	Shena Arellano	07/02/2007 - 07/02/2012
European Union EC, DG Enterprise	Information Sharing related to Cosmetics	N/A, Responsibilities transferred to DG SANCO	FDA [HTML] DG-Enterprise [HTML]	Shena Arellano	07/02/2007 - 07/02/2012
European Union (EFSA)	Information Sharing related to food and feed	Foods	FDA [HTML] EFSA [HTML]	Shena Arellano	07/02/2007 In effect indefinitely
European Union (EMA)	Information Sharing	Drugs, Biologics, Animal & Veterinary Products	FDA [HTML] EMA [HTML]	Shena Arellano	In effect indefinitely
European Union (EC, DG SANCO)	Information Sharing	Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products, tobacco products	FDA [HTML] DG-SANCO [HTML]	Shena Arellano	6/6/2005 In effect indefinitely
France	Information Sharing	Drugs, Biologics, Medical Devices, Cosmetics	FDA and ANSM formerly AFSSAPS [HTML] Name Change notification Pdf [137 KB]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	Extended indefinitely 2/08/2006 - 2/08/2011
France	Information Sharing	Foods, Animal & Veterinary	FDA-ANSES [HTML]	Shena Arellano	3/21/2011 In effect indefinitely
Germany	Information Sharing	Drugs, Biologics and Animal & Veterinary	FDA [HTML] PEI [HTML]	Shena Arellano	1/30/2006 In effect indefinitely
Germany	Information Sharing	Foods and Radiation-Emitting Products	BFUNR-FDA [HTML]	Shena Arellano	02/04/2005 In effect indefinitely
Germany	Information Sharing	Drugs, Medical Devices	BfArM-FDA [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	02/02/2005 In effect indefinitely
Germany	Information Sharing	Foods, Animal & Veterinary and Tobacco Products	BVL [HTML]	Shena Arellano (Drugs and Biologics)	02/12/2010 In effect indefinitely
Germany	Information Sharing	Foods, Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics, Radiation-Emitting Products and  Tobacco Products	BMG [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	01/25/2008 In effect indefinitely
Ireland	Information Sharing	Drugs, Biologics, Medical Devices, Animal & Veterinary, Cosmetics,	FDA [HTML] IMB [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	9/20/2005 In effect indefinitely
Ireland	Information Sharing	Good laboratory practices	INAB [HTML]	Shena Arellano	06/14/2005 In effect indefinitely
Israel	Information Sharing	Drugs, Medical Devices, Foods, Veterinary Drugs, Cosmetics, Radiation-Emitting Products	FDA [HTML] The Administration [HTML]	Layla I. Batarseh	12/15/2005 In effect indefinitely
Italy	Information Sharing	Drugs	FDA [HTML]  AIFA [HTML]	Shena Arellano	12/04/2009 In effect indefinitely
Japan	Information Sharing	Animal Foods and feeds, Veterinary drugs	FDA [HTML] FSCAB and NVAL [HTML]	Sema D. Hashemi	3/16/2012 In effect indefinitely
Japan	Information Sharing	Biologics, Human Drugs, and Medical Devices	FDA [HTML] PMDA [HTML]	Sema D. Hashemi	09/15/2004 In effect indefinitely
Japan	Information Sharing	Biologics, Cosmetics, Human Drugs, Food and Medical Devices	FDA [HTML] PFSB[HTML]	Sema D. Hashemi	09/15/2004 In effect indefinitely
Mexico	Information sharing	Foods, Drugs, Medical Devices, Biologics, Cosmetics, Radiation-Emitting Products, Tobacco Products	FDA [HTML] En Español COFEPRIS [HTML] En Español	Phyllis Marquitz	04/15/2002 In effect indefinitely
Mexico	Information sharing	Foods, Animal & Veterinary	SAGARPA [HTML]	Phyllis Marquitz	5/7/2004 In effect indefinitely
Netherlands	Information sharing	Drugs, Biologics, Medical Devices, Animal & Veterinary, Foods	FDA [HTML] MEB-IGZ [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	10/02/2006 In effect indefinitely
New Zealand	Information sharing	Tobacco Products	FDA [HTML] The Ministry [HTML]	Michael J. Airumian	9/30/2011 In effect indefinitely
New Zealand	Information sharing	Foods	FDA [HTML] NZFSA [HTML]	Michael J. Airumian	10/28/2004 In effect indefinitely
New Zealand	Information sharing	Drugs, Biologics, Medical Devices, Radiation-Emitting Products	Medsafe [HTML]	Michael J. Airumian	03/02/2007 In effect indefinitely
Panama	Information sharing		FDA [HTML] ARAP [HTML]	Phyllis Marquitz	06/28/2012 In effect indefinitely
Singapore	Information sharing	Biologics, Cosmetics, Human Drugs, Medical Devices and Tobacco Products	FDA [HTML]  HSA [HTML]	Russell C. Campbell	8/25/2004 In effect indefinitely
South Africa	Information sharing	Biologics and Human Drugs, and Veterinary Products	FDA [HTML]  MCC [HTML]	Russell C. Campbell	12/06/2004 In effect indefinitely
Sweden	Information Sharing	Drugs, Biologics, Medical Devices, Cosmetics	FDA [HTML]  MPA [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	03/31/2006 In effect indefinitely
Switzerland	Information sharing	Drugs, Biologics, Medical Devices, Animal & Veterinary	Swissmedic [HTML]	Shena Arellano	9/17/2003 In effect indefinitely
United Kingdom	Information Sharing	Biologics	FDA [HTML] NIBSC [HTML]	Shena Arellano	01/05/2012 In effect indefinitely
United Kingdom	Information Sharing	Foods	FDA [HTML] FSA [HTML]	Shena Arellano	10/02/2008 In effect indefinitely
United Kingdom	Information Sharing	Drugs, Biologics, Medical Devices	FDA [HTML] MHRA [HTML]	Shena Arellano (Drugs and Biologics) Shena Arellano (Medical Devices)	04/29/2010 In effect indefinitely
United Kingdom	Information Sharing	Animal & Veterinary	FDA [HTML] VMD [HTML]	Shena Arellano	08/22/2011 In effect indefinitely
WHO	Information Sharing	Medical Devices, Drugs, and Biologics	FDA-WHO/EHT/DLT [HTML]	Tammie J. Bell	10/10/11 In effect indefinitely
WHO	Information sharing	Tobacco	FDA-WHO/TFI [HTML]	Tammie J. Bell	04/12/2011 In effect indefinitely
WHO	Products Approved under PEPFAR and WHO’s Prequalification Program	Health related products (PEPFAR)	FDA/WHO [HTML]	Russell C. Campbell	8/11/2005 In effect indefinitely
WHO	Information sharing	Drugs, human Biologics	FDA-WHO/IVB/QSS [HTML]	Tammie J. Bell	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) 796-4600