The Committee discusses the permission for Mifegymiso

Depending on whether or not it has bridging studies, the timing of its release in Korea will vary depending on the results

Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body.

 

The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea.

 

The MFDS will hold a meeting at the Central Pharmaceutical Advisory Committee on the 2nd to ask whether Mifegymiso-related safety and validity are reasonable.

 

The meeting is expected to receive comments on the current controversial Bridging Study.

 

"We will discuss Mifegymiso's Bridging Study at the Central Pharmaceutical Advisory Committee," said an official at the MFDS.

 

"Based on the results of the consultation, we will review the direction of the item permit review." If Mifegymiso is granted, it will be the first for the medical termination of a regency in Korea.

 

The MFDS has changed its registration to allow abortion to be introduced in accordance.

 

Since there have been no medications for termination of pregnancy, other medications have been used for termination of pregnancy.

 

In July, Hyundai applied for permission from Mifegymiso (Mifepristone and Misoprostol), an oral medication.

 

The drug is supplied by British pharmaceutical company Linepharma International and will be supplied exclusively by Hyundai.

 

The MFDS has also begun a full-fledged review.

 

It is heard that screening such as safety, validity, quality, and GMP is currently underway.

 

Some in the medical community argue that bridging study should be carried out to secure safety for Koreans before using the drug.

 

The women's community argues that Mifegymiso's Bridging Study should be omitted and approved quickly because Bridging Study has no substitute and can be exempted if necessary.

 

As a result of social controversy, the MFDS has formed an expert to ask whether it is bridging study.

 

If the Central Pharmaceutical Advisory Committee decides on the pros and cons of Bridging Study, the MFDS is likely to accept it.

 

If bridging study is carried out, the item permit is expected to be delayed due to a period of about a year.

 

Attention is focusing on what scientific conclusions the MFDS will reach amid controversy.