Oh Yu-kyung, the Minister of the Food and Drug Safety Agency, emphasized the need for legal measures to ensure the safe use and compensation for side effects of the abortion drug mifepristone.
During a National Assembly audit on October 13, Oh stated, "Currently, young women in our country are receiving drugs with severe side effects illegally, which leaves them unprotected in a blind spot." He added, "It is appropriate to approach this in a way that can provide relief to women through more legal means."
The government announced last month its plan to introduce abortion medication, aiming to complete the approval and review process by the first quarter of next year. The plan is to allow the use of abortion pills for pregnant women within nine weeks (63 days) of pregnancy starting as early as the first quarter of next year.
President Lee Jae-myung also stressed the importance of ensuring the safe administration of mifepristone during a Cabinet meeting in July. The government believes it is necessary to manage women who obtain and use the drug illegally within a regulated framework rather than leaving them unattended.
The Food and Drug Safety Agency reaffirmed its stance that it will not conduct separate bridging studies for the introduction of mifepristone for Koreans. Bridging studies are tests conducted to confirm safety and efficacy differences based on race or country when introducing drugs used abroad.
Oh reiterated this position during the National Assembly audit, stating, "To date, there have been no confirmed unusual reactions based on race or country for mifepristone."
Meanwhile, cases of suspected vision damage, known as NAION, have been reported following the administration of glucagon-like peptide-1 (GLP-1) obesity and diabetes treatment drugs in Korea.
Oh Yu-kyung noted, "One case was reported (in December 2024)," explaining that it is categorized as a "rare but possible side effect."
NAION, referred to as 'eye stroke,' is a leading cause of optic nerve blindness after glaucoma. It can lead to permanent blindness due to the destruction of the optic nerve caused by a lack of blood supply.
During a National Assembly audit on October 13, Oh stated, "Currently, young women in our country are receiving drugs with severe side effects illegally, which leaves them unprotected in a blind spot." He added, "It is appropriate to approach this in a way that can provide relief to women through more legal means."
The government announced last month its plan to introduce abortion medication, aiming to complete the approval and review process by the first quarter of next year. The plan is to allow the use of abortion pills for pregnant women within nine weeks (63 days) of pregnancy starting as early as the first quarter of next year.
President Lee Jae-myung also stressed the importance of ensuring the safe administration of mifepristone during a Cabinet meeting in July. The government believes it is necessary to manage women who obtain and use the drug illegally within a regulated framework rather than leaving them unattended.
The Food and Drug Safety Agency reaffirmed its stance that it will not conduct separate bridging studies for the introduction of mifepristone for Koreans. Bridging studies are tests conducted to confirm safety and efficacy differences based on race or country when introducing drugs used abroad.
Oh reiterated this position during the National Assembly audit, stating, "To date, there have been no confirmed unusual reactions based on race or country for mifepristone."
Meanwhile, cases of suspected vision damage, known as NAION, have been reported following the administration of glucagon-like peptide-1 (GLP-1) obesity and diabetes treatment drugs in Korea.
Oh Yu-kyung noted, "One case was reported (in December 2024)," explaining that it is categorized as a "rare but possible side effect."
NAION, referred to as 'eye stroke,' is a leading cause of optic nerve blindness after glaucoma. It can lead to permanent blindness due to the destruction of the optic nerve caused by a lack of blood supply.
* This article has been translated by AI.
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