The South Korean government has announced plans to introduce abortion medication, drawing attention to the timeline for Hyundai Pharmaceutical's distribution of 'Mifepristone.' Hyundai Pharmaceutical has applied for approval for Mifepristone three times since 2021, with the most recent application currently under review after being submitted in December of last year.
On September 16, during the 14th National Policy Coordination Meeting held at the Government Seoul Building, the Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety reported on the introduction of abortion medication. This marks the first concrete plan from the government since the Constitutional Court's ruling on abortion in 2019.
The abortion medication under review is being considered for approval based on clinical trial data, with a proposed usage limit of up to 63 days, or nine weeks, into pregnancy. If approved by the Ministry of Food and Drug Safety, it is expected to be introduced under these conditions.
Shin Jun-soo, director of the Ministry of Food and Drug Safety's Drug Safety Bureau, stated during the briefing, "We aim to introduce the medication in the first quarter of next year, provided that all related procedures are thoroughly followed." He added, "While much of the review has progressed, there are still aspects such as the risk management plan that need to be approved. After approval, additional safety and quality inspections will be required, and we will do our utmost to ensure it is introduced by the first quarter of next year."
The pharmaceutical industry is closely watching Hyundai Pharmaceutical's Mifepristone. The company first applied for approval in July 2021 but withdrew the application due to requests for additional data. In 2023, another application was submitted, but the process was halted. In December 2024, a third application was made, again under the condition of use within 63 days of pregnancy.
Hyundai Pharmaceutical has previously signed an exclusive licensing and supply agreement for Mifepristone with the UK-based company Linepharma International.
Mifepristone is a combination product consisting of one 200 mg tablet of mifepristone and four 200 mcg tablets of misoprostol. Mifepristone blocks the hormone necessary for maintaining pregnancy, while misoprostol induces uterine contractions.
However, the actual launch date may vary depending on the Ministry of Food and Drug Safety's assessments of safety, efficacy, and quality, as well as the review of the risk management plan and import procedures following approval. The inclusion of the medication in health insurance and the pricing process may also impact the launch schedule.
The government plans to manage the introduction of abortion medication by allowing doctors to prescribe and dispense it directly within medical institutions for the first two years. After monitoring for side effects and safety, the government will consider expanding access to pharmacies.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.