[2026 Parliamentary Audit] Hyundai Pharmaceutical to Submit Supplementary Approval Materials for Mifegymiso Next Month... Safety and Bridging Study Debate

Lee Sangjun Appears at Health and Welfare Committee Audit
Minister Jeong Eunkyung: "Women's Safety Is the Top Priority"

Hyundai Pharmaceutical said it would submit supplementary materials by next month to obtain domestic marketing approval for Mifegymiso, a medication for terminating a pregnancy. As the government pursues the relevant procedures with a view to introducing the drug in the first quarter of next year, debate continued over the need to verify its safety and conduct a bridging study.

Lee Sangjun, CEO of Hyundai Pharmaceutical, answers a question from Lee Manhee, chair of the National Assembly Health and Welfare Committee, after appearing as a witness at the committee's comprehensive audit on the 27th. National Assembly Broadcasting.

Lee Sangjun, CEO of Hyundai Pharmaceutical, appeared at the National Assembly Health and Welfare Committee's comprehensive audit on the 27th. Asked about the timeline for submitting materials related to Mifegymiso's approval, he said, "We are preparing to submit them without fail by next month at the latest."

Hyundai Pharmaceutical is seeking to introduce Mifegymiso, an oral medication for terminating a pregnancy developed by the UK's Linepharma International. Mifegymiso is a combination drug containing mifepristone and misoprostol. The government is proceeding with the relevant procedures with the aim of introducing it in the first quarter of next year, but the actual distribution timeline depends on subsequent steps, including approval by the Ministry of Food and Drug Safety.

Concerns about the drug's safety were raised during the audit. Kim Jaeyeon, president of the Korean Association of Obstetricians and Gynecologists, said it was concerning that the country was rushing to introduce the drug while the U.S. Food and Drug Administration (FDA) was conducting a safety review. "It is testing on the public," he said, criticizing the plan: "I wonder if this is not tantamount to conducting a kind of experiment on women who are highly vulnerable and sensitive when it comes to childbirth."

Whether sufficient consideration had been given to response measures for emergencies following use of the drug also became an issue. "There is no control tower among the relevant agencies," Kim said, questioning whether there had been sufficient consultation with the medical community during the process.

Ruling and opposition lawmakers took opposing positions on whether a bridging study should be conducted for the drug. A bridging study assesses whether a drug's safety and efficacy differ depending on race or country. Lee Manhee , chair of the Health and Welfare Committee and a member of the People Power Party, said, "In clinical trials in Japan, adverse events such as lower abdominal pain and vomiting occurred in about 57% of cases," and argued that "a bridging study is also necessary in Korea."

In contrast, Nam Insoon, a lawmaker from the Democratic Party of Korea, explained, "When Hyundai Pharmaceutical first applied for marketing approval in July 2021, a bridging clinical trial was discussed, but the Central Pharmaceutical Affairs Council decided not to conduct one in September of that year."

In response, Lee said, "We are discussing with the Ministry of Food and Drug Safety how to manage risks after the drug is launched." He added, "We are aware of concerns about the risks of the drug itself, as well as distribution and misuse," and said, "The Ministry of Food and Drug Safety is taking a very conservative approach and discussing how to manage it safely."

Lee took a cautious stance on sales projections following Mifegymiso's approval. "It is difficult to find accurate statistics on the number of abortions (pregnancy terminations)," he said. "Past studies gave an estimate of about 30,000 cases, but specific information, such as the figures by week of pregnancy, was lacking."

Health and Welfare Minister Jeong Eunkyung said, "Women's safety is paramount, so we will consult with the medical community and prepare to establish a system for safe use." She added, "Regarding amendments to laws related to pregnancy termination, the Ministry of Justice is preparing the revision to the Criminal Act, while the government will actively cooperate as the National Assembly reviews relevant bills concerning the Mother and Child Health Act."

This content was produced with the assistance of AI translation services.