The U.S. government has decided to strengthen unannounced inspections of overseas pharmaceutical manufacturing facilities. Previously, U.S. President Donald Trump indicated that tariffs would be imposed on overseas pharmaceuticals and that policies would be pursued to produce more pharmaceuticals domestically. To this end, he instructed the U.S. Department of Commerce to investigate the impact of pharmaceutical imports on national security.
According to the Korea Bio Association on the 11th, the U.S. Food and Drug Administration (FDA) recently announced plans to expand unannounced inspections of overseas manufacturing facilities producing pharmaceuticals. FDA Director Martin Makary said it is "a measure to level the playing field between U.S. and foreign (pharmaceutical) competition."
The U.S. Food and Drug Administration has conducted unannounced inspections of domestic pharmaceutical manufacturing facilities without exception. There were concerns that overseas facilities were inspected after advance notice, which was deemed unfair. As a result, unannounced inspections were being piloted in China and India, but it will now expand to other countries.
The Korea Bio Association noted that this is interpreted as a measure to promote the core production of pharmaceuticals in the U.S. Domestic corporations producing biopharmaceuticals are also expected to be affected.