FDA TO TEAM UP WITH EUROPE ON INSPECTIONS

JULY 01, 2008

The FDA and the European Medicines Agency plan to pilot a joint inspections program of facilities manufacturing pharmaceuticals in the United States and the European Union, as well as companies manufacturing active pharmaceutical ingredients (API) in third countries. The plan was announced following a recent meeting of the Transatlantic Economic Council in Brussels.

The project will include the exchange of inspection schedules, results, and information on inspected manufacturing sites. The FDA expects the collaboration will yield important benefits for industry and patients and result in more effective use of resources and a higher safety level of products from third countries.

Concern over the quality of API manufactured abroad was heightened after numerous adverse reactions and deaths were linked to contaminated heparin produced in China (see www.PharmacyTimes.com/OverseasInspections for more information).

A budget amendment to increase FDA appropriations by an additional $275 million in fiscal year (FY) 2009 is moving through Congress. The agency plans to use the additional funding, in part, to expand its reach beyond American borders by establishing a presence in several countries and through other measures that will help ensure greater foreign compliance with FDA standards. The increase would bring the FDA's proposed total budget increase to $404.7 million, a 17.8% boost in funding from FY 2008.



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