The MFDS is pre-reviewing a combination of Mifegyne

The MFDS should take the lead in marketing permission for abortion pill

The safety and efficacy of Mifepristone·Misoprostol are being reviewed

The MFDS announced that it is in the process of applying for a preliminary review of the combination drug Mifepristone(generic for Mifegyne) and Misoprostol.

 

The MFDS has also initiated a guideline for safe use of abortion pill and is also planning to collect opinions from experts such as gynecologists and women's groups.

 

On the 24th, the MFDS made this announcement in a written inquiry by Nam In-soon, a member of Democratic Party of Korea and the National Assembly's Health and Welfare Committee.

 

She inquired about the current status of domestic screening along with the efficacy and safety of Mifegyne in use in 74 countries around the world.

 

The MFDS replied that it is being used after individual safety and efficacy evaluations along with each country's health care environment.

 

The MFDS announced that it is confirming the application for a preliminary review of Mifepristone & Misoprostol.

 

In other words, some domestic pharmaceutical companies are preparing for marketing permission for abortion pills.

 

Preliminary review is a system in which the standards for preparing data required for drug marketing approval are reviewed in advance prior to formal marketing approval.

 

All of the Mifepristone·Misoprostol combination drugs that have been requested for preliminary review are drugs used overseas as abortion pills.

 

Mifepristone, generic for Mifegyne, is a drug that prevents fetal growth.

 

Many foreign countries are using it, but it was not imported into Korea.

 

Misoprostol induces uterine excretion, and is used in the treatment of gastric duodenitis in Korea.

 

It means that in order to use it as an abortion pill in Korea, it is necessary to expand the indications to change the permission matters such as indications and dosage.

 

The MFDS announced that it has also begun to establish guidelines for safe use of abortion pill.

 

In addition, the MFDS said that it would prepare abortion pill-related policies through a procedure for collecting opinions from experts in various fields such as obstetricians, gynecologists and women's organizations.

 

By referring to overseas prescription cases, even if they are not obstetricians, it is expected that doctors who have completed certain training can prescribe prescriptions.

 

The MFDS said, "We have initiated a preliminary review of Mifepristone·Misoprostol.

 

We will also prepare guidelines for safe use.

 

We will thoroughly verify the safety and effectiveness of the product so that the drug can be used based on the doctor's accurate diagnosis." The MFDS said, "If there is a request for an evaluation to expand the indications of Misoprostol, we will conduct safety and efficacy evaluations." It added, "When establishing related policies with abortion pills, we will consider a plan to expand accessibility together with safety."