The government is set to officially integrate abortion medications, which have been illegally distributed and posed safety risks to women, into the national healthcare system.
On September 16, the Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Korea Food and Drug Administration jointly reported a plan for the introduction of abortion medications during the 14th National Policy Coordination Meeting held at the Government Seoul Complex.
This initiative follows a directive from the President in July to explore the possibility of allowing abortion medications, marking the first institutional improvement in seven years since the Constitutional Court's ruling on the unconstitutionality of the abortion law in April 2019.
The government's decision to formally introduce these medications comes amid concerns that unregulated and unsafe alternatives have proliferated during a prolonged legislative gap, severely threatening women's health. According to the Ministry of Gender Equality and Family, the lack of a proper system has significantly restricted women's choices regarding surgical and medication options tailored to their health needs, leading to increased socioeconomic burdens due to rising costs associated with delayed abortions. The government anticipates that the formal approval of abortion medications, including mifepristone, will help eliminate underground transactions while enabling systematic monitoring of usage, safe medication guidance, and thorough post-use management.
The Korea Food and Drug Administration will oversee the approval and safety verification of these medications. The agency plans to conduct thorough reviews based on clinical trial data for the abortion medications currently undergoing import approval and assessment. The usage criteria for the approved medications will be set for within 63 days (9 weeks) of pregnancy. The agency will focus on ensuring the effectiveness and quality of the medications, as well as collecting and evaluating adverse event reports post-marketing, investigating safety information, and distributing educational materials to patients and professionals as part of a Risk Management Plan (RMP). Oh Yu-kyung, head of the Korea Food and Drug Administration, stated, "We will thoroughly review the approval application materials with public safety as our top priority."
The Ministry of Health and Welfare reported a phased introduction plan to prevent misuse in medical settings and establish a safe usage environment. For the first two years of the medication's introduction, the ministry will require that doctors directly prescribe and dispense the medications within healthcare facilities. After this initial period, the ministry will discuss gradual expansion plans, including dispensing at external pharmacies, based on the review of adverse event occurrences and safety evaluations. Jeong Eun-kyung, Minister of Health and Welfare, emphasized, "We will do our utmost to create safe usage conditions in the field following the approval of the medications."
On September 16, the Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Korea Food and Drug Administration jointly reported a plan for the introduction of abortion medications during the 14th National Policy Coordination Meeting held at the Government Seoul Complex.
This initiative follows a directive from the President in July to explore the possibility of allowing abortion medications, marking the first institutional improvement in seven years since the Constitutional Court's ruling on the unconstitutionality of the abortion law in April 2019.
The government's decision to formally introduce these medications comes amid concerns that unregulated and unsafe alternatives have proliferated during a prolonged legislative gap, severely threatening women's health. According to the Ministry of Gender Equality and Family, the lack of a proper system has significantly restricted women's choices regarding surgical and medication options tailored to their health needs, leading to increased socioeconomic burdens due to rising costs associated with delayed abortions. The government anticipates that the formal approval of abortion medications, including mifepristone, will help eliminate underground transactions while enabling systematic monitoring of usage, safe medication guidance, and thorough post-use management.
The Korea Food and Drug Administration will oversee the approval and safety verification of these medications. The agency plans to conduct thorough reviews based on clinical trial data for the abortion medications currently undergoing import approval and assessment. The usage criteria for the approved medications will be set for within 63 days (9 weeks) of pregnancy. The agency will focus on ensuring the effectiveness and quality of the medications, as well as collecting and evaluating adverse event reports post-marketing, investigating safety information, and distributing educational materials to patients and professionals as part of a Risk Management Plan (RMP). Oh Yu-kyung, head of the Korea Food and Drug Administration, stated, "We will thoroughly review the approval application materials with public safety as our top priority."
The Ministry of Health and Welfare reported a phased introduction plan to prevent misuse in medical settings and establish a safe usage environment. For the first two years of the medication's introduction, the ministry will require that doctors directly prescribe and dispense the medications within healthcare facilities. After this initial period, the ministry will discuss gradual expansion plans, including dispensing at external pharmacies, based on the review of adverse event occurrences and safety evaluations. Jeong Eun-kyung, Minister of Health and Welfare, emphasized, "We will do our utmost to create safe usage conditions in the field following the approval of the medications."
* This article has been translated by AI.
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