The Ministry of Food and Drug Safety’s review of Mifegymiso (ingredient: mifepristone, misoprostol), an oral treatment for abortion, has not made progress for five months.

Civic groups, including a union of health and medical workers, issued a statement to urge the MFDS’ swift approval for the drug.

The MFDS received the application for Mifefymiso approval from Hyundai Pharm in July 2021. Earlier, the ministry had said it would mull a quick evaluation on an abortion drug, considering the need for women’s rights to health.

However, the MFDS has sat idle since November, when it held an advisory meeting of experts.

In a recent meeting with health reporters, the MFDS said, “We are assessing the drug's safety, efficacy, and quality after receiving the application for approval.”

The MFDS went on to say that it requested Hyundai Pharm to submit supplementary data.

As Hyundai Pharm requested the ministry to postpone the deadline for data submission, the ministry would review supplementary materials when submitted, the MFDS said.

The MFDS’ reply is the same as what Food and Drug Safety Minister Kim Gang-lip said at a parliament audit in October last year.

Regarding whether the ministry would waver a bridging trial for Mifegymiso, a key to introducing the abortion pill in Korea, the MFDS mentioned lawmakers’ comment at the audit last year that a law revision was necessary and refused to comment further.

“The National Assembly took issues with replacing drug evaluation with a bridging trial. The parliament said it should first amend the related law to protect patient safety,” the MFDS said. “The ministry is thoroughly reviewing the need for a bridging study and data submitted by the company.”

The ministry’s comment implies that it took a step back from the previous stance of wavering on a bridging trial.

At the National Assembly’s audit, Kim said, “If a bridging trial is applied, it will take at least two to three additional years (to introduce the drug).” However, the ministry received advice from the Central Pharmaceutical Affairs Council on this matter, and a majority of experts said the government could exempt a bridging trial, he added.

Asked why the MFDS has not prepared any follow-up bill after abortion became decriminalized in 2019, the MFDS said it was necessary to “create a legal environment where abortion drugs can be used stably.”

The food and drug safety ministry would work with the Ministry of Justice and the Ministry of Health and Welfare to actively support the parliament’s legislative amendment process, the MFDS added.

Last year, physician groups such as the Korean Association of Obstetricians & Gynecologists argued that if the MFDS approves an abortion medicine without subsequent legislation, it will abuse administrative power.

In a briefing to reporters, the MFDS’ drug policy division said it could approve an abortion drug without legislation.

On Thursday, the Korean Health and Medical Workers' Union (KHMU) called for the MFDS to grant the regulatory nod for Mifegymiso, saying women wishing to discontinue pregnancy remained in a “blind spot” of the law, although one year has passed since the clause of criminalizing abortion was removed from the criminal law.

“The MFDS sought to block Women on Web, an international non-profit organization that sends abortion drug Mifegyne,” KHMU said. “Some pregnant women try out abortion by using a drug with an unclear ingredient purchased from an illegal online site and suffer from adverse reactions.”