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International Programs
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Confidentiality Commitments
| COUNTRY | SUBJECT | LINKS | CONTACT | DATES Effective/Expiration |
|---|---|---|---|---|
| Australia | Information Sharing | FDA [HTML] APMVA [HTML] |
Michael J. Airumian |
10/20/2005 In effect indefinitely |
| Australia | Information Sharing | [HTML] | Michael J. Airumian |
08/11/2004 In effect indefinitely |
| Australia/New Zealand | Information Sharing | FDA [HTML] FSANZ [HTML] |
Michael J. Airumian |
04/15/2008 In effect indefinitely |
| Austria | Information Sharing |
FDA [HTML] BASG [HTML] |
Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
08/18/2009 In effect indefinitely |
| Belgium | Information Sharing | [HTML] | Shena Arellano |
12/15/2004 In effect indefinitely |
| Belgium | Information Sharing | [HTML] | Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
04/23/2007 In effect indefinitely |
| Canada | Information Sharing | FDA [HTML] CFIA [HTML] |
Charles A. Gaylord |
12/22/2003 In effect indefinitely |
| Canada, Mexico and United States | Information Sharing | FDA [HTML] Health Canada [HTML] COFEPRIS [HTML] |
Sheri L. Schwartzback |
06/21/2004 In effect indefinitely |
| Canada | Information Sharing | FDA [HTML] HPFB of Health Canada [HTML] |
Charles A. Gaylord |
11/18/2003 In effect indefinitely |
| Denmark | Information sharing | FDA [HTML] DMA [HTML] | Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
11/14/2007 In effect indefinitely |
| Council of Europe | Information Sharing | FDA [HTML] EDQM [HTML] | Shena Arellano |
05/04/2009 In effect indefinitely |
| European Union EC, DG Enterprise | Information Sharing related to Medical Devices | FDA [HTML] DG-Enterprise [HTML] | David P. Kelly |
07/02/2007 - 07/02/2012 |
| European Union EC, DG Enterprise | Information Sharing related to Cosmetics | FDA [HTML] DG-Enterprise [HTML] |
David P. Kelly |
07/02/2007 - 07/02/2012 |
| European Union (EFSA) | Information Sharing related to food and feed | FDA [HTML] EFSA [HTML] | David P. Kelly |
07/02/2007 In effect indefinitely |
| European Union (EC, DG Enterprise/EMEA) |
Information Sharing | FDA [HTML] EMEA [HTML] Extension [HTML] | Shena Arellano |
9/12/2003 - 9/12/2005 Extended 9/15/2005 - 9/15/2010 |
| European Union (EC, DG SANCO) |
Information Sharing | FDA [HTML]DGSANCO [HTML] | David P. Kelly |
6/6/2005 In effect indefinitely |
| France | Information Sharing | FDA and AFSSAPS [HTML] | Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
2/08/2006 - 2/08/2011 |
| France | Information Sharing | AFSSA-FDA [HTML] | Shena Arellano |
0/07/2005 In effect indefinitely |
| Germany | Information Sharing | FDA [HTML] PEI [HTML] | Shena Arellano |
1/30/2006 In effect indefinitely |
| Germany | Information Sharing | BFUNR-FDA [HTML] | Shena Arellano |
02/04/2005 In effect indefinitely |
| Germany | Information Sharing | BfArM-FDA [HTML] | Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
02/02/2005 In effect indefinitely |
| Ireland | Information Sharing | FDA [HTML] IMB [HTML] |
Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
9/20/2005 In effect indefinitely |
| Ireland | Information Sharing | INAB [HTML] | Shena Arellano |
06/14/2005 In effect indefinitely |
| Israel | Information Sharing |
FDA [HTML] The Administration [HTML] |
Layla I. Batarseh |
<>12/15/2005 In effect indefinitely |
| Japan | Information Sharing |
FDA [HTML] PMDA [HTML] |
Sema D. Hashemi | 09/15/2004 In effect indefinitely |
| Japan | Information Sharing |
FDA [HTML] PFSB[HTML] |
Sema D. Hashemi | 09/15/2004 In effect indefinitely |
| Mexico | Information sharing | COFEPRIS [HTML] | Naomi Kawin |
04/15/2002 In effect indefinitely |
| Mexico | Information sharing | SAGARPA [HTML] | Naomi Kawin |
5/7/2004 In effect indefinitely |
| Netherlands |
FDA [HTML] MEB-IGZ [HTML] |
Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
10/02/2006 In effect indefinitely |
|
| New Zealand | Information sharing |
FDA [HTML] NZFSA [HTML] |
Michael J. Airumian |
10/28/2004 In effect indefinitely |
| New Zealand | Information sharing | Medsafe [HTML] | Michael J. Airumian |
03/02/2007 In effect indefinitely |
| Singapore | Information sharing |
FDA [HTML] HSA [HTML] |
Russell C. Campbell |
8/25/2004 In effect indefinitely |
| South Africa | Information sharing |
FDA [HTML] MCC [HTML] |
Russell C. Campbell |
12/06/2004 In effect indefinitely |
| Sweden | Information Sharing |
FDA [HTML] MPA [HTML] |
Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
03/31/2006 In effect indefinitely |
| Switzerland | Information sharing | Swissmedic [HTML] | David P. Kelly |
9/17/2003 In effect indefinitely |
| United Kingdom | Information Sharing |
FDA [HTML] MHRA [HTML] |
Shena Arellano (Drugs and Biologics) David P. Kelly (Medical Devices) |
02/14/05 In effect indefinitely |
| WHO | Products Approved under PEPFAR and WHO’s Prequalification Program | FDA/WHO [HTML] | Russell C. Campbell | 8/11/2005 In effect indefinitely |
| WHO | Information sharing | 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)
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