Policy & Regulation
Plan aims to curb illicit distribution and bring medication under government oversight, protecting women’s safety and health rights For the first 2 years, doctors would directly prescribe and dispense the medication

The government is moving to formally introduce abortion medication into the national health care system. This would be the first policy improvement in 7 years since the Constitutional Court ruled the abortion ban unconstitutional.
The Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety reported plans to introduce medication for 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 a follow-up to President Lee Jae-myung’s directive in July to review the possibility of allowing abortion medication. The aim is to bring medication that has been distributed illicitly under government oversight and protect women’s safety and health rights.
The Ministry of Gender Equality and Family reported that women’s health and safety problems are arising as a legislative vacuum has persisted since the Constitutional Court’s ruling that the abortion ban was unconstitutional and the introduction of medication has been delayed.
Problems on the ground include the illegal distribution of medication whose safety has not been verified and the widespread use of substitutes, restrictions on the right to choose between surgery and medication, and rising costs due to delays in care.
The Ministry of Food and Drug Safety said the abortion medication currently undergoing import approval and review was submitted for use through 63 days (9 weeks) of pregnancy, based on clinical trial data. The ministry plans to thoroughly review its safety, efficacy, quality and risk management plan.
The Ministry of Health and Welfare decided that, for the first 2 years after the medication’s introduction, it would be managed under a principle requiring doctors to prescribe and dispense it directly at medical institutions. The ministry will consider gradually expanding access 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 overall, but institutional shortcomings have meant that individuals’ rights to safely access the health care system have not been protected."
She added, "We expect abortions to be carried out more safely under the national health care system and the burden to be reduced for 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 the abortion medication is approved." Oh Yu-kyung, head of the Ministry of Food and Drug Safety, said, "We will thoroughly review the approval application materials, with public safety as our top priority."

Biobook Team
biobookmedia@biobook.co.kr
AI Virtual Control Groups Move Into the Regulatory Spotlight for Drug Approvals as U.S. and Korean Regulators Convene

Surge in Companies Abandoning Essential Drug Production; MFDS Closes 63.8% of Cases With ‘No Action Needed’

Biotechs Sell Bread and Cosmetics Instead of Developing Drugs as Delisting Rules Distort Their Core Business

“A 30-day IND review is window dressing”: Biotech industry urges response to China’s speed

MFDS Approves First Domestically Developed GLP-1 Obesity Drug

Pharmacies to Remove ‘Warehouse’ and ‘Mart’ From Signs
Rural Development Administration Develops Two Molecular Markers to Identify Leaf Splitting in Squash
MFDS Begins Distribution of Internationally Certified Reference Materials, Including 24 New Items, for a Total of 882
Ministry of Trade, Industry and Energy signs agreement to promote biotech and medical devices in Gangwon; site visit set for the 14th