South Korea's Ministry of Food and Drug Safety plans to review the abortion pill widely known as Mifegyne for approval without requiring a separate clinical trial in Korean patients, on the grounds that the drug has been used abroad for decades across a range of ethnic groups.
Oh Yu-kyoung, the ministry's commissioner, told a full session of the National Assembly's Health and Welfare Committee on the 17th that no bridging trial had been conducted, after Rep. Cho Bae-sook of the People Power Party stressed the need for such a study in Korean women. "Mifegyne has been used since 1988 in about 100 countries, including Japan, European nations and the United States, among diverse ethnic groups, so we obtained an opinion through expert consultation that a bridging trial is not necessary," Oh said.
A bridging trial is a study designed to confirm whether the safety and efficacy of a drug developed overseas apply equally to Korean patients.
When Cho noted that the U.S. Food and Drug Administration is reviewing the safety of the drug again, the ministry explained that drug distribution conditions differ between the United States and South Korea.
"In the United States, telemedicine has been in use since the COVID-19 period, and Mifegyne is distributed through remote delivery," Oh said. "We understand that the post-marketing safety review is being conducted because of the distinctive nature of that distribution channel."
Relevant government agencies announced a day earlier that they would formally bring abortion pills into the regulatory system, and the ministry is aiming to introduce the drug by the first quarter of next year.
On the approval and review timeline, Oh said the ministry could not pin down a specific month. "The company has to submit supplementary materials to a level we find satisfactory, so we cannot state exactly which month approval will come," she said. "We will move as quickly as we can on the parts within our control."
The session also brought criticism over an omitted animal-testing report involving Genencell, which has faced allegations of improper lobbying for clinical trial approval of a new drug.
A court ruling related to Genencell is said to have included a finding that one of five hamsters infected with COVID-19 and dosed with a candidate treatment vomited blood and died.
Cho said the ministry "should apologize to the public and put measures in place to prevent a recurrence."
Oh said the matter was not known at the time of the 2021 review and came to the ministry's attention only after the 2024 ruling was issued. "We deeply regret learning of it after the fact, and we intend to work out substantive policy improvements on this point," she said.
