‘Mifegyne set for Q1 launch next year’

MFDS nearing completion of review for use through 9 weeks of pregnancy…launch likely without reimbursement

Pharmacy dispensing to be excluded for first 2 years due to potential pharmacist liability and safety concerns

Physician dispensing may be extended if legal amendments are delayed or safety concerns remain

Guidelines to address prescriber qualifications and criteria for minors

MOHW Soon Hun Kwak, Director General for Health Care Policy, is briefing on the domestic introduction plan for Mifegyne.

The Korean government plans to officially introduce the medical abortion drug Mifegyne (mifepristone/misoprostol) as early as Q1 next year. For the first 2 years following its introduction, pharmacy dispensing will be excluded, with physicians directly prescribing and dispensing the drug within medical institutions. The period could be extended depending on legislative changes and the incidence of adverse events.

The exact timing of the launch will depend on cooperation between the pharmaceutical company that filed for approval and the government. Authorities plan to expedite administrative procedures, with a focus on safety and efficacy, in an effort to secure Korean approval as early as the beginning of next year.

The government said the decision to require in-hospital dispensing for the first 2 years was based on two considerations: an existing Ministry of Justice interpretation that pharmacists could face criminal liability because the Criminal Act and the Mother and Child Health Act have yet to be amended, and the need to prioritize patient safety.

The government plans to assess safety and monitor progress on the relevant legislative amendments during the first two years before deciding whether to gradually expand dispensing. Officials said the 2 years could be extended if legislative changes are delayed or concerns over adverse events remain unresolved. Under the regimen currently under review, patients take the first drug, mifepristone, followed by the second drug, misoprostol, 24 to 48 hours later, and return to the hospital within 7 to 14 days for follow-up.

On the 16th, the Ministry of Food and Drug Safety (MFDS), Ministry of Health and Welfare, and Ministry of Gender Equality, among other relevant government agencies, provided an update on the regulatory review and outlined plans for the phased introduction of the medical abortion drug in Korea.

Launch possible as early as Q1 next year…use through 9 weeks of pregnancy

The MFDS is currently reviewing supplementary materials and a risk management plan for the imported drug application submitted in December 2024.

The proposed indication covers pregnancies of up to 9 weeks, in line with the submitted application. The regimen consists of mifepristone followed by misoprostol 24 to 48 hours later, with a hospital follow-up visit within 7 to 14 days.

Jun-soo Shin, Director-General of the Pharmaceutical Safety Bureau at the MFDS, said, “If the company’s submission of supplementary documents and the import process, including quality testing and securing supply, proceed without disruption, we will work to make the drug available in Korea as early as the beginning of next year, no later than the first quarter.”

Physician dispensing within hospitals required for 2 years… legislative developments to be considered

For the first 2 years after the drug is introduced, the government plans to require physicians to prescribe and dispense it directly within medical institutions. The decision reflects both the Ministry of Justice’s interpretation that pharmacists could potentially face criminal liability while the Criminal Act and the Mother and Child Health Act remain unchanged, and the government’s emphasis on patient safety.

In fact, the Constitutional Court’s 2019 decision finding the abortion ban unconstitutional was applied only to pregnant women and physicians. This is why the Ministry of Justice has interpreted the current Criminal Act as leaving open the possibility that pharmacists could be punished for dispensing or selling the medication.

From a patient safety and adverse-event monitoring perspective, the government also believes that medical professionals capable of determining gestational age through ultrasound and ruling out ectopic pregnancy should directly supervise treatment during the initial rollout.

The 2-year in-hospital dispensing policy is a temporary measure, but it is not subject to an automatic sunset and could remain in place longer depending on circumstances.

A government official said, “We will assess safety over the 2 years and monitor progress on the relevant legislative amendments before deciding whether to expand dispensing in stages. If legislative amendments are delayed or concerns about adverse events remain unresolved, the 2-year in-hospital dispensing requirement could be extended.”

Guidelines to be set for prescriber qualifications and minors…non-reimbursed launch likely

Rather than limiting prescribing to obstetricians and gynecologists, the government plans to work with the medical community to establish standard clinical guidelines centered on physicians capable of interpreting ultrasound findings and identifying contraindications. The guidelines will also address whether parental consent should be required when the drug is administered to minors, taking into account youth protection systems and psychological and emotional support measures.

Pricing and National Health Insurance coverage will depend on whether the pharmaceutical company applies for reimbursement, but the drug is considered likely to launch on a non-reimbursed basis.

If launched without reimbursement, medical institutions will be required to disclose the price and provide information to patients in advance, while the Health Insurance Review & Assessment Service will publish comparative pricing information. Separate consideration will be given to insurance coverage for procedures conducted before treatment, including ultrasound examinations.

The government also plans to establish a monitoring system and continue developing measures to address potential access barriers among vulnerable populations, including women living in rural areas with limited access to hospitals, adolescents and low-income patients. The government said it would actively participate in National Assembly discussions on amendments to the Mother and Child Health Act in the second half of the year in an effort to address the existing legal gap.