Policy & Regulation
Gender Equality Ministry, Health Ministry and MFDS report plan at national policy coordination meeting Physician prescribing to be the rule for first 2 years, with gradual expansion after safety review

The government is moving to formally introduce medication abortion into the national health care system. It is the first policy improvement in 7 years since the Constitutional Court ruled that the criminalization of abortion was unconstitutional.
The Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety reported a plan to introduce medication abortion at the 14th National Policy Coordination Meeting, held on the 16th at the Government Complex Seoul.
The measure is a government policy priority and follows President Lee Jae-myung’s directive in July to review the possibility of allowing medication abortion. The aim is for the government to manage medication abortion drugs (Mifegyne), which have been distributed through unofficial channels, to protect women’s safety and right to health.
The Ministry of Gender Equality and Family said that illegal distribution of drugs whose safety has not been verified, along with the widespread use of substitutes, compromises safety and limits women’s right to choose surgery or medication based on their health status. It also cited socioeconomic burdens, including increased costs resulting from delays, as a reason for urgent introduction.
The ministry expects formal approval of the drugs to make it possible to assess patterns of use, ensure safe use and provide follow-up care.
The Ministry of Food and Drug Safety said that the medication abortion drug currently undergoing review for import approval was submitted for use through 63 days (9 weeks) of pregnancy, based on clinical trial data. The MFDS plans to thoroughly review the approval application materials, including the risk management plan, to ensure safety, efficacy and quality.
The Ministry of Health and Welfare said it would consider requiring direct prescribing and dispensing by physicians at medical institutions during the first 2 years after the drugs are introduced, followed by gradual expansion after reviewing adverse effects and safety.
Won Min-kyung, minister of gender equality and family, said, “Pregnancy and childbirth are decisions that have a profound impact on women’s lives, but institutional shortcomings have meant that individuals’ rights to safely access the health care system have not been guaranteed.”
Won added, “We expect abortion to be carried out more safely within the national health care system and to ease the burden on women facing socioeconomic circumstances that leave them with no choice but to have an abortion.”
Jeong Eun-kyeong, minister of health and welfare, said, “We will work to create conditions for safe use after medication abortion drugs are approved,” while Oh Yu-kyung, commissioner of the Ministry of Food and Drug Safety, said, “We will thoroughly review the approval application materials for medication abortion drugs, with public safety as our top priority.”

Biobook Team
biobookmedia@biobook.co.kr
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