Pro-choice groups and health experts have expressed split opinions on whether to conduct a bridging trial of Mifegymiso (ingredient: mifepristone/misoprostol), an abortion drug that will arrive in Korea soon.
A bridging trial aims to obtain clinical data for Koreans when it is difficult to apply foreign clinical trial results due to differences in ethnic factors.
Hyundai Pharm recently applied for marketing approval for Mifegymiso, an abortion pill, but the Ministry of Food and Drug Safety (MFDS) remained passive to accelerate the review process.
Industry watchers are questioning why the regulator has reversed its stance after promising accelerated approval for the drug.
기자명 Kim Chan-hyuk
Hyundai Pharm made it official that it will supply Mifegyne, an abortive drug, in Korea. Industry watchers said the supply could open ways for medication abortion.
However, as the company is preparing for the regulator’s preliminary review before seeking the nod, it will take a considerable time until a pregnant woman gets a Mifegyne prescription, observers said.
Calls grow to legalize abortion drugs
Posted : 2019-07-21
By Bahk Eun-ji
Concern is rising over the growing illegal online sale of "abortion drugs," the effects of which have not been proven.
With a law banning abortion ruled unconstitutional earlier this year, women's rights groups say the nation needs urgently to legalize the prescription and sale of abortion drugs so women can use safe and authorized medicine.