A box containing a Mifepristone tablet is seen at Blue Mountain Clinic in Missoula, Montana, on Feb. 28, 2023.REUTERS/YONHAP
Korea could allow the use of the abortion pill Mifegyne as early as this year, as the government nears the end of its approval review.
“Government ministries are discussing guidelines for the safe use of Mifegyne and are considering allowing it for pregnancies of up to nine weeks,” a government official told the JoongAng Ilbo. “It could become available in Korea as early as this year.”
The Ministry of Food and Drug Safety is reviewing Hyundai Pharm’s application to approve Mifegymiso tablets, filed in December 2024.
The medication is taken in two steps: one tablet of mifepristone blocks the hormone needed to sustain a pregnancy, followed by four tablets of misoprostol that trigger uterine contractions to expel the pregnancy tissue.
The World Health Organization recommends the combination for abortion in early pregnancy. It added the two drugs to its Model List of Essential Medicines in 2005. The regimen is approved for use in about 100 countries, including the United States, Japan, France and Britain.
The Korean Drug Ministry had maintained that it could not proceed with its review until lawmakers passed legislation defining when and how abortions are permitted.
Although Hyundai Pharm first sought approval in 2021, the drug’s introduction has been delayed by requests for additional data and the absence of legislation. The pharmaceutical company withdrew its initial application after it was unable to provide the additional data requested at the time, then resubmitted its application with the required materials in 2024.
The Drug Ministry shifted its position after the Ministry of Government Legislation concluded that abortion medication could be approved before amendments to the Mother and Child Health Act.
An advertisement for Mifepristone written in Korean in 2019SCREEN CAPTURE
A governmentwide review began after President Lee Jae Myung ordered officials in July to examine introducing Mifegyne. Through discussions coordinated by the Office for Government Policy Coordination, relevant ministries arrived at a legal interpretation that allowed the approval process to move ahead before the law is revised.
“The scope of the review extends beyond approval itself to what measures are possible before legislation and how the drug can be used safely,” a Drug Ministry official said.
The Ministry of Health and Welfare — in parallel with the Drug Ministry’s review — is working with the medical community to create guidelines for prescribing and using Mifegyne. They are expected to cover eligibility, gestational limits, preuse testing, follow-up care and how to manage adverse effects.
The government plans to keep both prescribing and dispensing of Mifegyne within medical institutions until lawmakers revise the Mother and Child Health Act. That would allow tighter safety controls at the outset while sidestepping potential criminal liability for pharmacists.
In 2019, the Constitutional Court found unconstitutional the provision that punished women for having abortions, as well as a provision from the Criminal Act that applied to physicians performing abortions. The two provisions became invalid when lawmakers failed to replace them by the end of 2020.
The court’s ruling did not extend to the part of the law covering pharmacists, which leaves them punishable by up to two years in prison for assisting in an abortion at a woman’s request or with her consent.
The government’s own legal consultations reached a similar conclusion: Pharmacists could be subject to criminal punishment if they dispense abortion medication.
“For Mifegyne to be used under the current legal framework, prescriptions and dispensing would initially have to take place within hospitals,” a Health Ministry official said.
Mifegyne would be prescribed and dispensed only within hospitals during its first two years of availability, Lee said during a meeting with civic groups on Friday. After that initial period, the government plans to allow patients to fill hospital-issued prescriptions at outside pharmacies.
That shift would require lawmakers to revise relevant laws, including the provision that leaves pharmacists open to criminal penalties.
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.
