President Lee Jae-myung on the 16th called for an overhaul of the entire approval and review system, saying at a Ministery of Food and Drug Safety work briefing, "Speed up approvals and reviews for biopharmaceuticals and medical devices so we can process reviews the fastest in the world."
At the Ministery of Food and Drug Safety work briefing held that afternoon at the Government Sejong Convention Center, the president, referring to the approval and review period for pharmaceuticals including therapeutics and new drugs, as well as medical devices, said, "On the premise of safety, push measures to cut the timeline to the shortest possible period," and "Expand staffing to support this at the same time." This is to check on the implementation progress of directives personally issued at the "Bio Innovation Forum" in Sep. last year.
In response, Minister Oh Yu-Kyoung of the Ministery of Food and Drug Safety said, "While placing safety first, we will drastically shorten approval and review times," and "We will improve the review system, which has been relatively slower than the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and build a system to process within 240 days, the world's shortest level, down from the current average of 420 days." She added, "We will achieve innovation across food and drug administration by using AI."
To shorten approval and review periods, the Ministery of Food and Drug Safety raised new drug review fees from the current 8.83 million won to as much as 410 million won. The increased fees will be used to expand specialized staff, including those with experience at contract research organizations (CROs).
Minister Oh explained, "We have finalized the first round of hiring for 207 positions and will begin posting notices starting in Jan. next year," adding, "We will proceed with a second round of hiring next year as well." In response, the president emphasized quick results, saying, "We need to pick up the pace."
Plans for AI-based administrative innovation were also included as a key report item. Minister Oh presented plans to introduce ▲"Online AI Cops," which monitors real-time online sales of narcotics and illegal medicines ▲"AI Import Inspector," which precisely blocks hazardous imported foods ▲"AI Foreign Matter Investigator," which improves the accuracy of foreign matter detection. The Ministery of Food and Drug Safety plans to invest 15 billion won next year to commercialize AI medical devices.
The president also reviewed measures to strengthen narcotics safety management. The Ministery of Food and Drug Safety reported measures to strengthen systems to prevent misuse and abuse of medical narcotics, as well as plans for prevention and rehabilitation support.
On the genetically modified organism (GMO) labeling system, the president emphasized consumers' right to know. The president said, "People must be able to know and judge whether the food I eat is genetically modified or natural." Minister Oh explained, "Currently, six genetically modified grains are approved by the Ministery of Food and Drug Safety in Korea, and the inflow of unapproved varieties is being blocked through next-generation sequencing."
Meanwhile, the president noted that when an administrative system disruption occurred due to the National Information Resources Service fire in Sep. last year, the Ministery of Food and Drug Safety separated and operated service windows for food, pharmaceuticals, and medical devices, saying, "On-site response in a crisis was swift and appropriate."