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FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

Aug 12th, 2010

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The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products.  In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot.

The two agencies are conducting joint inspections to help both agency and industry participants save resources and avoid duplication of effort and to determine if the collaboration will help to more effectively deploy inspection resources and allow more manufacturing sites to be inspected.  EMA is taking the lead in coordinating the joint inspections.

The request for participants is the latest development in the pilot, begun two years ago as one outcome of the Transatlantic Administrative Simplification (TAS) initiative which involved US and EU regulators and industry (IPQ Report Nov./Dec. 2008).

[More on the EMA/FDA joint inspection pilot procedures and participation,  and links to the referenced documents, are provided for subscribers on page 2.]

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