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  • MFDS says, abortion drug approval cannot be reviewed
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Jul 30, 2025 06:16am
"Amendment to the law must be established first"
The efficacy, dosage, etc., can only be set once medication-induced abortion are clearly defined by law
Hyundai Pharm agrees with the current situation¡¦filed a marketing authorization application in December 2024
 ¡ã Product photo of
Hyundai Pharm filed a marketing authorization application for oral abortion drug 'Mifegymiso Tab (mifepristone¡¤misoprostol)' last year. However, it has been confirmed that, under the current state of legislative void, the review cannot even begin.

On the 30th, the Ministry of Food and Drug Safety's (MFDS) Pharmaceutical Approval Management Division responded to an inquiry from specialized journalists, stating, "The review of Mifegymiso Tab can only commence once a legal basis is established, and currently, review is not possible." They added, "Hyundai Pharm also understands that the efficacy, indications, dosage, and administration, etc., can only be set once the allowance and permissible gestational age for medi
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