FDA and EU Commission inform about Collaboration on Inspections

To foster the transatlantic co-operation between the European Medicines Agency (EMEA) and the US Food & Drug Administration (FDA) both agencies agreed on a "Transatlantic Administrative Simplification Ation Plan" (June 2008). To get a picture of the progress in implementing administrative simplification projects and to identify the opportunities at a practical level - meaning administrative practices and guidelines - the two authorities conducted a bilateral meeting in September. The projects highly relevant for the GMP environment according to the "Implementation Report 2009" are as follows (text taken from press release):

"1) Collaboration on inspections in the US and EU

The Commission/EMEA and the FDA have piloted joint inspections of companies manufacturing pharmaceuticals in the U.S. and in the EU. Two joint inspections of manufacturing sites in the EU were completed successfully in April and July 2009 respectively. An observed inspection was carried out in the US. The experience from these inspections has resulted in some agreed opportunities for improvement which will be developed as part of the ongoing collaborative activities.

2) Collaboration on 3rd country inspections of API´s

In November 2008, the Commission/EMEA and the FDA, in collaboration with TGA, Australia, published an 18 month pilot project for exchange of inspection schedules, results, and information on inspections of active pharmaceutical ingredient manufacturing sites in third countries. Information is exchanged on an ongoing basis. To-date 80 sites have been identified for joint collaboration, 4 inspection reports have been exchanged and 1 joint inspection performed in June 2009, thus facilitating better use of EU/FDA combined inspectional resources.

3) Dedicated facilities for high risk products

The Commission/EMEA and the FDA continue to share experience with a view towards determining the best international approach to the extent to which dedicated production facilities may be necessary for certain pharmaceuticals taking into account a risk based approach."

More details can be found at the European Commission Webpage.

Prepared by
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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