Will Abortion Pill 'Mifjimiso' Finally Be Launched in Korea After 5 Years?

Hyundae Pharm Under Third Review for Marketing Approval
Key Issues: Prescription, Distribution, and Health Insurance Coverage

As the government officially moves to introduce abortion drugs, "Mifjimiso" by Hyundai Pharm, which has been undergoing approval procedures in Korea for five years, is once again drawing attention. There is growing interest in when approval might be granted and how the medication will be supplied to medical institutions after approval.

Oh Youkyung, Commissioner of the Ministry of Food and Drug Safety (right), is attending the National Policy Coordination Meeting held at the Government Seoul Office Building in Jongno-gu, Seoul on September 16, 2026. Photo by Jo Yongjun

According to the government and pharmaceutical industry on September 16, Hyundai Pharm has secured the exclusive domestic rights for the oral abortion drug "Mifjimiso" through a contract with the UK-based pharmaceutical company Linepharma International. However, despite applying for marketing authorization three times since 2021, the drug has not yet been introduced in Korea due to legal and regulatory gaps and requests for additional documentation.

Mifjimiso is a combination pack consisting of one tablet of mifepristone 200mg and four tablets of misoprostol 200mcg. Mifepristone works by blocking the action of progesterone, a hormone necessary to sustain pregnancy, while misoprostol induces uterine contractions to facilitate abortion. These drugs, commonly referred to as "Mifjin" in Korea, refer collectively to either mifepristone monotherapy or abortion drugs based on mifepristone.

Hyundai Pharm first applied for marketing authorization for Mifjimiso in July 2021, but voluntarily withdrew the application after being asked by the Ministry of Food and Drug Safety to provide additional safety, efficacy, and quality data. In March 2023, the company filed a second application, but the process was temporarily halted because revisions to criminal and maternal and child health laws regarding abortion needed to be prioritized.

Subsequently, in December 2024, Hyundai Pharm submitted a third marketing authorization application with the condition that the drug could be used within 63 days (9 weeks) of pregnancy, and the approval process for this application is currently ongoing. The Ministry of Food and Drug Safety has stated that it will thoroughly review safety, efficacy, quality, and risk management plans in the authorization submission related to abortion drugs.

Even after obtaining drug approval, there remain additional issues before patients can actually receive prescriptions. During the National Policy Coordination Meeting on September 16, the Ministry of Health and Welfare reported plans to implement a principle of physician-direct prescription and dispensing within medical institutions for the first two years after introducing abortion drugs, with a gradual expansion after monitoring safety and side effects.

The pharmaceutical industry predicts that once approval is granted, Hyundai Pharm will secure products and begin supplying them to medical institutions, marking the start of domestic distribution.

Whether the medication will be covered by national health insurance and the pricing decisions are also variables. If Mifjimiso is introduced as a non-reimbursed drug, it can be supplied to medical institutions after marketing authorization, preparation for manufacturing/import, and distribution procedures. However, if it is designated as an insured medication, additional procedures such as setting the insurance price will be needed, potentially extending the timeline for its actual launch.

Oh Youkyung, Commissioner of the Ministry of Food and Drug Safety, stated, "We will conduct a thorough review of all authorization materials for abortion drugs, prioritizing public safety above all else."

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