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U.S. Department of Health and Human Services

International Programs

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Transatlantic Economic Council High Level Regulatory Cooperation Forum

Believing that transatlantic economic integration will maximize economic benefits for their citizens through competition and stronger growth, while maintaining high standards of safety and protection, at their Summit meeting in April 2007, the leaders of the EU and the US committed their governments to increasing the efficiency and transparency of transatlantic economic cooperation and to accelerating the reduction and elimination of barriers to international trade and investment with the ultimate objective of achieving a barrier-free transatlantic market.

The leaders of the EU and the US agreed on a framework for advancing transatlantic economic integration and established the Transatlantic Economic Council (TEC) to oversee the efforts outlined in the framework, with the goal of accelerating progress and guiding work between EU-US Summits.

FDA has reported under the TEC umbrella for several areas of EU-US cooperation. The most robust of these concern FDA activities with the European Medicines Agency and the European Commission. Those projects include the following:

  1. Collaboration on inspections
  2. Collaboration on third country inspections
  3. Dedicated facilities for high risk products
  4. Biomarkers
  5. Regulatory collaboration on the outputs of the Critical Path and Innovative Medicines Initiatives
  6. Combating counterfeit medicines
  7. Collaboration on product specific risk management activities
  8. Convergence of risk management formats
  9. Parallel scientific advice
  10. Exchange of information on herbal medicines
  11. Collaboration on biosimilar medicinal products / follow-on biologics
  12. Collaboration on development of medicinal products for children
  13. Advanced therapy medicinal products
  14. Safety reporting from clinical trials
     

Transatlantic Task Force on Antimicrobial Resistance (TATFAR)

 


 

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