Abortion medications available within the first 50 days of pregnancy
Hyundai Pharm failed to submit clinical data to the Food and Drug Safety Administration and voluntarily withdrew
The introduction of ‘Mifejimisojeong’ (trade name: Mifegene), an abortion drug, is expected to be delayed indefinitely.
On the 16th, the Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) reviewed the license as Hyundai Pharm voluntarily withdrew the application for the item permission of the pregnancy abortion drug ‘Mifjimi Sojeong’, which was reviewed on July 2 the last year he said the process was over.
Mifjimiso is an abortion drug that can be used within the first 50 days of pregnancy and was included in the list of essential drugs by the World Health Organization (WHO) in 2005.
However, since it is a product containing a new substance used for the first time in Korea, the Ministry of Food and Drug Safety requested the addition of some data on safety, efficacy and quality according to the new drug review standards . However, Hyundai Pharm was granted an additional data supplementary period by extending the deadline for submission of supplementary data (twice), but voluntarily withdrew the application for product approval, judging that it was difficult to submit some supplementary data within the time limit.
An official from the Ministry of Food and Drug Safety explained, “It is considered a measure that was determined to fail to prepare some necessary data for the final review within the deadline.” .
The Ministry of Food and Drug Safety intends to review supplementary items not submitted in this review if the company re-applies for item approval for ‘Mifjimi Sojeong’ in the future.
Jang Ji-min, Hankyung.com guest reporter newsinfo@hankyung.com
