Hyundai Pharm to ‘reapply for Mifegymiso’s item permit’

Hyundai Pharm said Monday that it would reapply for the permit of Mifegymiso (mifepristone/misoprostol), an oral abortion drug, to the Ministry of Food and Drug Safety.

“We have submitted most supplementary data according to the review results of the Ministry of Food and Drug Safety, but failed to present some data within the deadline,” a company official told Korea Biomedical Review. “So we will cancel the existing application and reapply for the permit after securing missing data.”

Hyundai Pharm voluntarily withdrew its application for the permit of Mifegymiso last Thursday. The following day, the Ministry of Food and Drug Safety said it completed the review process of Mifegymiso.

According to the ministry, Hyundai Pharm voluntarily withdrew its application, judging it would be difficult to submit data additionally requested by the ministry to be supplemented concerning the drug’s safety, efficacy, and quality.

“After reviewing the safety, efficacy, and quality data, the Food and Drug Safety Ministry asked us to supplement missing and insufficient data. Therefore, it is right that we withdraw the application for failing to furnish some data,” the company official said.

However, when asked about data it failed to submit, the official did not elaborate, saying, “It is difficult to disclose the insufficient data because it is information related to the drug’s original developer.”

According to reports, Hyundai Pharm submitted data when acquiring the permit from the Canadian health authorities in 2015 to the Ministry of Food and Drug Safety.

Asked when Hyundai Pharm would reapply, the official said, “It is also difficult to talk about the exact timing. However, we plan to reapply as soon as we gather data to the maximum, and are discussing with the original developer and preparing actively.”

In March 2021, Hyundai Pharm signed a contract with the U.K.-based Linepharma International to sell and supply Mifegymiso exclusively in the domestic market and applied for its permit to the Ministry of Food and Safety in July of the same year.

The ministry soon held a meeting of advisors, raising expectations about its early approval. Then, however, the procedure was put to a brake as the need rose for its bridge clinical trials.

“If the company reapplies for the permit of Mifegymiso, the ministry will focus on supplemented data,” a ministry official said. “We will continue to do our best to permit drugs with guaranteed safety, efficacy, and quality based on scientific and regulatory expertise.”