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[Alpha Biz= Kim Jisun] The U.S. government has announced plans to intensify surprise inspections of overseas pharmaceutical manufacturing facilities, as part of a broader effort to bolster domestic drug production and address national security concerns related to pharmaceutical imports.



This move follows directives from former President Donald Trump, who previously indicated intentions to impose tariffs on imported pharmaceuticals and prioritize domestic manufacturing. To that end, the U.S. Department of Commerce has been instructed to investigate the national security implications of pharmaceutical imports.



According to the Korea Biotechnology Industry Organization (KoBioLabs) on May 11, the U.S. Food and Drug Administration (FDA) recently announced its plan to expand unannounced inspections of foreign drug manufacturing sites. Martin Makary, Director of the FDA, stated that the measure is aimed at "leveling the playing field between domestic and international pharmaceutical manufacturers."



Traditionally, the FDA has conducted surprise inspections of domestic facilities without prior notice, while inspections of overseas facilities were typically scheduled in advance, raising concerns about fairness. While pilot unannounced inspections have been carried out in China and India, the FDA now plans to extend these inspections to other countries.



KoBioLabs commented that the move appears to be aligned with President Trump’s agenda to encourage domestic production of critical medicines. Korean biopharmaceutical companies are also expected to be affected by the expanded inspections and policy shift.

 

 

 

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