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Focus on Regulation

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition for pharmaceutical manufacturing inspections.  The amended agreement will allow FDA and EU regulators to rely upon information from drug inspections conducted within each other’s borders.  According to FDA, over the last 5 years, about 40 percent of FDA’s drug inspections were performed in the EU.  Although FDA inspections in the EU are sure to continue, this agreement now allows FDA to shift even more inspections to China, India, and Asia more broadly, where drug manufacturing has greatly increased along with FDA’s enforcement focus.