Korea to introduce Mifegyne abortion pill without domestic safety trial
The Food and Drug Safety Ministry says Mifegyne's decades of use abroad makes a separate Korean safety study unnecessary before its planned introduction.
Food and Drug Safety Minister Oh Yu-Kyoung speaks during a parliamentary Health and Welfare Committee meeting held at the National Assembly on Sept. 17.YONHAP
Korea would not conduct a separate clinical trial to assess the safety of the abortion pill Mifegyne before its domestic introduction, the Ministry of Food and Drug Safety said Thursday.
“Mifegyne has been used since 1988 among people of various racial backgrounds in about 100 countries, including Japan, European countries and the United States,” Food and Drug Safety Minister Oh Yu-Kyoung said during a parliamentary Health and Welfare Committee meeting held at the National Assembly in western Seoul.
“We concluded that a bridging study was unnecessary based on consultations with experts. We, therefore, did not conduct one,” Oh said.
A bridging study evaluates the safety and efficacy of a drug developed overseas on the local population.
Rep. Cho Bae-sook of the main opposition People Power Party raised questions about Mifegyne’s safety and cited an ongoing review by the U.S. Food and Drug Administration. The ministry responded that the issue concerns how the drug is distributed.
“In the United States, telemedicine expanded during the Covid-19 pandemic, and Mifegyne is now delivered remotely,” said Oh. “My understanding is that the post-marketing safety review has to do with how the drug is distributed.”
Abortion pill MifegyneJOONGANG ILBO
The Korean government announced Wednesday that it would move to make abortion medication legally available within the health care system. The ministry has set a target of introducing the drug by the first quarter of next year.
The minister held off on setting a specific timeline for the drug’s approval.
“We cannot say exactly which month the drug will be approved because the pharmaceutical company still has to provide additional information that satisfies our requirements,” said Oh. “But we will move as quickly as we can on our end.”
Lawmakers at Thursday’s meeting also questioned the ministry over Covid-19 vaccine maker Genencell’s omission of findings from an animal study. The company has separately faced allegations that Justice Minister nominee Kim Seung-won sought favors to secure approval for a clinical trial of its ultimately failed drug.
A court ruling involving Genencell showed that one of five Covid-19-infected hamsters treated with the drug candidate vomited blood and died. That information was omitted from the materials submitted to the ministry.
“We only became aware of this after a court ruling was issued in 2024, so it was not something we knew during the 2021 review,” Oh said. “We regret that we learned of it later and will look carefully at how our policies should be improved.”
This article was originally written in Korean and translated by a bilingual reporter with the help of generative AI tools. It was then edited by a native English-speaking editor. All AI-assisted translations are reviewed and refined by our newsroom.
