FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

U.S. Food and Drug Administration	European Commission	European Agency for the Evaluation of Medicinal Products

_______________________________________________________

U.S. FDA - EUROPEAN UNION

European Commission and
European Agency for the Evaluation of Medicinal Products

_______________________________________________________

COSMETICS

DRUGS AND BIOLOGICAL PRODUCTS

FOOD

MEDICAL DEVICES

VETERINARY MEDICAL PRODUCTS

Confidentiality Commitments on Cosmetics

• USFDA - [PDF 129KB] (July 2, 2007)
• EC - Entreprise and Industry Directorate-General - [PDF 118KB] (July 2, 2007)

DRUGS AND BIOLOGICAL PRODUCTS

USFDA and European Agency for the Evaluation of Medicinal Products

• Update on a pilot project to collaborate on international GMP inspection activities (January 8, 2009)



• EU Pilot Project on active pharmaceutical ingredient (API) manufacturer inspections [PDF 105KB]; Invitation letter [PDF 47KB]; and FDA Response [PDF 25KB]



• Medicines Regulation: Transatlantic Administration Simplification Action Plan [PDF 42KB] (June 17, 2008)



• Transatlantic Cooperation in Pharmaceutical Regulation: Identifying Opportunities for Administrative Simplification (December 4, 2007)



• Confidentiality Arrangements Concluded between the EU (EC and EMEA) and the US FDA/DHHS - Implementation Plan for Medicinal Products for Human Use (Updated June 2007)



• Project Outline: A common application format for orphan medicinal product designation in the European Union and the United States (June, 2007)



• Principles of Interactions: between EMEA and FDA Pediatric Therapeutics (June, 2007)



• EU (European Commission and EMEA) and FDA Agree on Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings (May 21, 2006)



• Cooperation on Drug Regulation Strengthened (March 14, 2006)



• General Principles EMEA - FDA Parallel Scientific Advice Meetings Pilot Program (September 17, 2004)



• Confidentiality Arrangements Concluded Between The EU (EC and EMEA) and AND The US FDA/DHHS Implementation Plan for Medicinal Products for Human Use (September 16, 2004)



• Arrangements
  
  • Extension (Letter of Exchange) - [PDF 94KB] (September 12, 2005)
  • FDA - Letter of Exchange - [PDF 193KB] (September 12, 2003)
  • EC/EMEA - Letter of Exchange (pdf) (September 12, 2003)

FOOD

USFDA and Health and Consumer Protection Directorate-General, (DG SANCO)

• Confidentiality Commitments
  • FDA Commitment (June 6, 2005) [PDF 56KB]
  • DG SANCO Commitment [PDF 34KB] (June 6, 2005)
    


• Implementation Plan on the Sharing of Confidential Information [PDF 217KB] (September 23, 2005)

MEDICAL DEVICES

Confidentiality Commitments on Medical Devices

• USFDA - [PDF306KB] (July 2, 2007)
• EC - Entreprise and Industry Directorate-General - [PDF 92KB] (July 2, 2007)

GHTF - Pilot Program

• FDA Extends Pilot Program for Evaluation of Globally Harmonized Medical Device Premarket Applications Until July 2006 (The STED Initiative).

VETERINARY MEDICAL PRODUCTS

Implementation Work Plan for Veterinary Medicinal Products

• Confidentiality Arrangements Concluded between the US Food and Drug Administration/DHHS and the European Union (EC and EMEA) - Implementation Procedures for Veterinary Medicinal Products Cluste (May 22, 2008)

Parallel Scientific Advice for Veterinary Medicinal Products

• General Principles - FDA/Center for Veterinary Medicine - EMEA/Veterinary Medicines and Inspections Unit - Parallel Scientific Advice Meetings (May 22, 2008).

OIP Home Page

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

Office of International Programs