European Commission

U.S. FDA - EUROPEAN UNION

Table of Contents

Cosmetics

Drugs and Biological Products

Food

Medical Devices

Veterinary Medical Products 

Cosmetics
 

Confidentiality Commitments on Cosmetics
 

• USFDA (July 2, 2007)
   

DRUGS AND BIOLOGICAL PRODUCTS
 

USFDA and European Agency for the Evaluation of Medicinal Products
 

• Program to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers - February 2012
   
• Enhancing GMP Inspection Cooperation between EMA and FDA, December 5 2011
   
• Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011
   
• Frequently Asked Questions and Answers for the Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011 
   
• Final report on the International API inspection Pilot Programme, May 2011 
   
• Medicines Regulation: Transatlantic Administration Simplification Action Plan: Implementation Report - 2010 (Published July 27, 2011) | Pdf Format [98 KB]
   
• Interactions between the European Medicines Agency and U.S. Food and Drug Administration September 2009-September 2010  (June 2011)
   
• Announcement that the FDA and EMA have received first parallel quality-by-design application
   
• EMA-FDA pilot program for parallel assessment of Quality by Design applications (March 16, 2011)
   
• FDA New Release: FDA, EMA announce pilot for parallel assessment of Quality by Design applications (March 16, 2011)
   
• U.S.FDA - European Medicines Agency Good Clinical Practice Initiative Frequently Asked Questions and Answers
   
• EMA-FDA GCP Initiative - Terms of engagement and procedures for participating authorities (Pilot Phase (18 months): Start date 01 September 2009)
   
• Medicines Regulation: Transatlantic Administration Simplification Action Plan: Implementation Report - 2009 (October 26, 2009) 
   
• General Principles EMA - FDA Parallel Scientific Advice (July 22, 2009) 
   
• 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
  
  • Invitation letter
     
  • FDA Response 
     
  • API Interim Report
     
• Transatlantic Cooperation in Pharmaceutical Regulation: Identifying Opportunities for Administrative Simplification (December 4, 2007) 
   
• Confidentiality Arrangements Concluded between the EU (EC and EMA) 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 EMA and FDA Pediatric Therapeutics (June, 2007) 
   
• EU (European Commission and EMA) and FDA Agree on Guiding Principles for Joint FDA EMA Voluntary Genomic Data Submission Briefing Meetings (May 21, 2006) 
   
• Cooperation on Drug Regulation Strengthened (March 14, 2006) 
   
• Confidentiality Arrangements Concluded Between The EU (EC and EMA) and AND The US FDA/DHHS Implementation Plan for Medicinal Products for Human Use (September 16, 2004) 
   
• Arrangements 
  • Extension (Letter of Exchange) - (September 12, 2005) 
     
  • FDA - Letter of Exchange - (September 12, 2003) 
     
  • EC/EMA - Letter of Exchange (September 12, 2003)
     

FOOD
 

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

• Confidentiality Commitments 
  
  • FDA Commitment (June 6, 2005) 
     
  • DG SANCO Commitment (June 6, 2005) 
     
• Implementation Plan on the Sharing of Confidential Information (September 23, 2005)
   

MEDICAL DEVICES
 

Confidentiality Commitments on Medical Devices 
 

• USFDA - (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 EMA) - Implementation Procedures for Veterinary Medicinal Products Cluste (May 22, 2008)
   

Parallel Scientific Advice for Veterinary Medicinal Products
 

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