Regulator delays decision on abortion drug Mifegymiso

The Ministry of Food and Drug Safety (MFDS) said it has asked Hyundai Pharm to submit additional data to review marketing approval for Mifegymiso, oral medicine for termination of pregnancy.

The regulator also delayed the period of the approval application process, making it uncertain whether the abortion pill would get the permit within this year.

Kim Gang-lip (left in the front row), Minister of Food and Drug Safety, and Seo Kyung-won (right in the front row), Director General of the National Institute of Food and Drug Safety Evaluation, at a parliamentary audit on Oct. 8. (Credit: National Assembly Health and Welfare Commission press corp.)

The MFDS said in a written reply to an inquiry during the National Assembly’s audit that the ministry was reviewing Hyundai Pharm’s application for marketing approval for Mifegymiso tablet.

“Due to insufficient data during the review process, we requested the company to submit supplementary data and extended the processing period,” the MFDS said.

Initially, the MFDS set the deadline of the review period as Nov. 12, 120 business days from July 2, when Hyundai Pharm applied.

However, the deadline has been extended for an uncertain time, raising worries that the review process might be delayed.

Lawmakers raised similar concerns at the parliamentary inspection of the MFDS on Oct. 8.

Rep. Jung Choun-sook of the Democratic Party said, in October 2020, the Ministry of Health and Welfare and the MFDS discussed follow-up measures after the Constitutional Court ruled that the abortion law was unconstitutional.

“At that time, the MFDS had said it would review whether to approve an abortion drug even if it was before law revisions,” Jung said. “But the ministry doesn’t seem to be able to complete the review until the deadline of Nov. 12.”

The MFDS’ evaluation period might be extended even towards next year.

Some critics said the delay showed that MFDS’ preliminary review system did not serve its purpose.

The preliminary review system cuts trials and errors and saves approval time.

Hyundai Pharm applied for the preliminary review of the abortion medicine early this year but could not advance the marketing approval at all, critics said.

Some observers said the extension of the review period could be the MFDS’ strategy to “buy time” while gathering expert opinions on using the abortion pill and the prescription authority.

“Using Mifegymiso must go through the Central Pharmaceutical Affairs Council’s review,” Food and Drug Safety Minister Kim Gang-lip said at the parliament audit on Oct. 8. “The MFDS will decide on whether to grant a bridging trial exemption and how to take Mifegymiso to ensure safety.”

In the written reply to inquiries by lawmakers, the MFDS said a majority of experts at the Central Pharmaceutical Affairs Council said the ministry could exempt a bridging trial.

The regulator also said that it would refer to the global use of the abortion pill, the WHO guidelines, and submitted clinical data to determine the license for Mifegymiso.

Hyundai Pharm reportedly submitted Canadian data of Mifegymiso approval conditions to the MFDS.

Mifegymiso, released by Linepharma International, a British pharmaceutical company, is a composite pack of mifepristone, an abortion drug known as Mifegyne, and misoprostol, an oxytocic drug.

In March, Hyundai Pharm signed an exclusive agreement with Linepharma to sell Mifegymiso in Korea.

At the National Assembly’s audit, Rep. Suh Jung-sook of the People Power Party asked Hyundai Pharm CEO Lee Sang-joon how much revenue the company would earn if it won the nod for Mifegymiso.

Lee said, “It is difficult to know information about the (abortion drug) market. The number of total abortions is reported, but we cannot identify early-stage pregnancy cases within nine weeks who are eligible for the use of Mifegymiso.”