Hyundai withdraws application for Mifegymiso approval again

Mother and Child Health Act again serves as a barrier

MFDS “Relevant laws must be set first for review and approval”

Hyundai Pharm applied for the drug’s approval twice in 2021 and 2023, both of which were discontinued

Hyundai Pharm has reportedly voluntarily withdrawn the application it had filed for the marketing authorization of Mifegymiso (mifepristone and misoprostol), which the company had applied for approval as the first abortion pill in Korea.

 

Hyundai Pharm has requested approval for the abortion drug twice in the past, first in 2021 and then in 2023, but the Ministry of Food and Drug Safety has repeatedly asked for supplemental data, due to which the company has not been able to receive proper review.

 

According to the MFDS’s written response to a written inquiry made during the NA Audit by the Health and Welfare Committee on the 31st, the approval and review process for Mifegymiso was recently temporarily suspended due to the company’s withdrawal.

 

“Currently, there are some conditions that only be reviewed and approved after the Criminal Act and the Mother and Child Health Act is amended to allow drug-induced pregnancy termination and the permissible period of pregnancy termination are established by law,” said MFDS.

 

In other words, if the Criminal Act and the Mother and Child Health Act are not amended, it would be difficult to review Mifegymiso’s effect/efficacy, and risk management plan, among others.

 

The MFDS said, “Currently, the approval review process has been temporarily suspended (withdrawn) by mutual recognition of the applicant and the MFDS,” adding, “If the relevant laws are amended in the future and the applicant submits data accordingly, we plan to speed up the review and promptly make a decision.” Hyundai Pharm signed an exclusive marketing and distribution agreement for Mifegymiso’s supply in Korea with the UK-based Linepharma International in 2020, but the company has not been able to launch the drug in Korea due to disruptions in the approval process.

 

Mifegymiso comes in a combination pack that contains 1 200mg mifepristone tablet and 4 misoprostol 200ug tablets.

 

The drug inhibits the action of progesterone, the progestational hormone that sustains pregnancy, while misoprostol works to contract the uterus.

 

It is only indicated for use in the first trimester of pregnancy, up to 9 weeks, and is typically prescribed as one tablet of mifepristone followed by 4 tablets of misoprostol 36-48 hours later.

 

In April 2019, the Constitutional Court ruled the criminal offense of abortion (termination of pregnancy) unconstitutional, citing respect for women's right to bodily self-determination.

 

As of January 1, 2021, abortion was effectively legalized.

 

Upon the ruling, the Constitutional Court ordered the National Assembly to come up with an alternative legislation to reflect the decision, but 4 years have passed without such legislation being enacted.

 

In the 21st National Assembly, 7 bills to abolish the abortion law were introduced, including amendments to the Criminal Code and the Mother and Child Health Act, but were discarded with the closure of the 21st National Assembly.