The South Korean government has decided to move toward approving the domestic introduction of Mifegymiso, an abortion pill regimen known in Korea as "Mifegyne", according to government officials. The decision comes seven years after the Constitutional Court ruled in 2019 that the criminal abortion ban was unconstitutional, a decision that triggered debate over introducing the medication.
Related ministries, including the Prime Minister's Office, have settled on allowing the drug into the country, government agencies said on the 9th. Under Prime Minister Han Seong-sook, the Ministry of Health and Welfare, the Ministry of Gender Equality and Family, the Ministry of Justice and the Ministry of Food and Drug Safety are discussing import approval and guidelines for Mifegymiso.
The government has set the limit for use at nine weeks of pregnancy or less and plans to require prescription and preparation within hospitals for the first two years, officials said. Doctors would prescribe and prepare the drug at hospitals initially, shifting after two years to a system in which doctors prescribe and pharmacies dispense it.
The Ministry of Food and Drug Safety is continuing its review of the drug, for which Hyundai Pharmaceutical (004310) filed a product approval application in December 2024. The regimen combines mifepristone and misoprostol. Mifepristone blocks the hormonal activity needed to sustain a pregnancy, after which misoprostol induces uterine contractions to expel the pregnancy tissue.
Discussion of introducing the pill gained momentum after the Constitutional Court's 2019 ruling that the criminal abortion provision was unconstitutional. The provision lost legal force in 2021 under that decision, but follow-up legislation defining the scope and procedures for terminating a pregnancy has been delayed, leaving the question of the drug unresolved for years.
Introduction of the pill, part of the government's policy agenda, picked up speed after President Lee Jae-myung called for early adoption at a Cabinet meeting in July. The prime minister then held a series of meetings with the relevant ministries to reconcile differences, producing a concrete plan within two months.
"Final approval will be granted after the drug safety ministry completes its risk assessment," a Health and Welfare Ministry official said. The government plans to revise the Mother and Child Health Act this year so the system can be implemented on a stable footing, while also working on amendments to the criminal code.
