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  • U.S. issues orders to produce pharmaceuticals domestically
  • by Kim, Jin-Gu | translator Hong, Ji Yeon | May 9, 2025 06:00am
U.S. President Donald Trump issues orders to promote domestic production of medicines¡¦separate measure from tariffs on pharmaceuticals
"Includes details on requirement to strengthen inspections of manufacturing facilities overseas¡¦strengthened FDA audits and potentially higher related fees."

An executive order issued by U.S. President Donald Trump to promote domestic production of medicines could impose additional burdens on Korean pharmaceutical and biotech companies seeking entry into the U.S. market.

Included among the order¡¯s provisions is a requirement to strengthen inspections of manufacturing facilities outside the United States, a move analysts say will lead to more rigorous FDA audits and potentially higher related fees.

On the 8th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) released an analysis of the impact on Korea¡¯s pharmaceutical ¡©and biotech industry of the U.S. administration¡¯s 'Regulatory Relief to Promote Domestic Production of Critical Medicin
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