The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit.

Despite being advised to waiver the bridging study by the Central Pharmaceutical Affairs Council, the MFDS turned to take a more reserved position on the exemption of such trials. Considering the progress of the review, as Hyundai Pharm would need to prepare the supplementary data and receive another review for the submitted materials, it is predicted that it will be difficult for the company to obtain approval within this year.

According to the MFDS on the 17th, the authorities requested supplementary data for Hyundai Pharm’s application on Mifegymiso but deferred providing a definite answer on whether it will exempt a bridging clinical for the drug.

# A bridging study is added when it is difficult to apply foreign clinical trial results locally due to ethnic differences in evaluations.

In early September, the MFDS received a recommendation to waiver the bridging trial after holding a CPAC meeting. Since the addition of a bridging trial could postpone the approval of a drug by 2 to 3 years, whether the bridging trial will be initiated was the center of focus to the company as well as women’s and academic societies.

At the time, the prevailing opinion was that the MFDS would waive the bridging trial and rapidly progress the approval process in accordance with the advice from external experts. However, the ministry later changed its position, faced with opposition from the Korean College of Obstetrics & Gynecology and the concerns raised on the hasty introduction of the drug.

An MFDS official said, “We are aware of the great need for relevant regulations and drugs after abortion was decriminalized. However, we are also aware of the rising concerns over its safety, which is why we need to exercise caution on the matter.”

He added, “The ministry had requested Hyundai Pharm’s to submit supplementary data on the approval of Mifegymiso. We had requested supplements after consulting with external experts and conducting data review, and the company has not submitted the additional data yet.”

“We have set a deadline for the supplementary data submission, however, the deadline may be extended upon the company’s request. We can only proceed further after we receive the data,” said the official.

Regarding the initiation of a bridging study, the MFDS plans to reexamine the issue through further expert review.

The MFDS official said, “We have already completed seeking expert advice on conducting a bridging study for Mifegymiso, but did not make a decision at the ministry level on whether to request or waiver a bridging study.”

He added, “This seems to be an issue that should be reviewed after the additional data are submitted. We plan to once again review expert opinions on the matter after receiving the supplementary data.”