New Report on EU/EMEA and FDA Collaboration published

Currently, there are quite a few activities carried out by the EU and the U.S. Food and Drug Administration (FDA) to simplify administrative burden involved in medicines regulation. To give an overview about the activities, an implementation report on the 'Transatlantic Administrative Simplification Action Plan' has now been published. This report is a result of the recent annual EU-EMEA/ FDA bilateral meeting in September, where the parties updated on the progress and status of the various projects, like for example:

  • Collaboration on inspections in the US and EU (joint inspections of companies manufacturing pharmaceuticals in the U.S. and in the EU)
  • Collaboration on 3rd country inspections of APIs (exchange of inspection schedules, results and information on inspections of API manufacturing sites in third countries)
  • Dedicated facilities for high risk products (sharing experience with a view towards determining the best international approach)
  • Combating counterfeit medicines (exchange of information)
  • Collaboration on the development of medicinal products for children (bilateral discussion on the development of specific medicinal products for children)
  • Convergence in paediatric submissions (identifying opportunities for transatlantic convergence of submission format)

Summarised by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

P.S. EMEA and FDA speakers at FDA events:

  • Dr Janice M. Soreth, Deputy Director of the Europe/US FDA, Liaison to EMEA, located in London will talk about the international programs of the FDA at the 4th QP Forum of the European QP Association on 3-4 December 2009 in Barcelona.
  • Both EMEA PDCO and FDA representatives will speak at the ECA Good Development Practice Conference on Formulation Development & Manufacturing of Paediatric Drugs, 19-20 May 2010 in Vienna.

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