Discussions began on the scope of Mifegymiso license

Collect opinions from all walks of life

Moon Eun-hee, head of the pharmaceutical policy division at the MFDS

An expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law.

 

The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights.

 

It is a policy to decide through collecting opinions from all walks of life.

 

Moon Eun-hee, head of the pharmaceutical policy division, said on the 23rd, "We are scheduled to hold a meeting with experts on Mifegymiso screening measures on the 24th.

 

We are thinking about whether to limit prescription authority to obstetrics and gynecology and what capabilities we will describe." She added that Mifegymiso will basically be classified as Rx drug and compare preparation and administration cases in various countries to discuss whether it will be inpatient Rx or outpatient Rx.

 

However, she mentioned that an agreement with all walks of life is needed.

 

She stressed that she does not conduct a permit review on the premise of revising the criminal law related to abortion, but that she hopes the law will be revised as soon as possible so that licensed products can be used.

 

It is found to be contrary to the opinion that Mifegymiso's approval review should be delayed due to the lack of criminal law by Seo Jung-sook and others.

 

The abortion crime was abolished in 2018 when the Constitutional Court ruled against the Constitution.

 

At that time, the Constitutional Court recommended that supplementary legislation be completed by the end of 2020, and five bills, including related criminal laws, were submitted to the National Assembly, but have not been processed.

 

The criminal law contains specific conditions and regulations that allow abortion.

 

The MFDS expects that abortion drugs will not violate the revised law and plans to examine them according to scientific procedures and methods.

 

She explained, "I don't think that the termination of pregnancy in efficacy will apply to the revised Pharmaceutical Affairs Act related to the expression of abortion suggestion." She said, "Even in the revised criminal law, drugs, including drugs, are not considered to be applied to abortion conditions and grounds, but it seems that (related drug permission) is not desirable because it varies depending on interpretation." However, as collecting opinions from all walks of life is important, she plans to continue to discuss drug use.

 

"I don't think it will be concluded by a single meeting on the 24th," she said adding, "There has been a process of collecting opinions from all walks of life, but we will continue to receive opinions if necessary." The plan is to determine whether the method of collecting opinions will be a consultative body of experts or a larger scale such as public hearings depending on the situation.

 

For now, it is known that expert organizations such as Korean Association of Obstructors & Gynecologists, Korean Society of Obstetrics and Technology, and Korea Society of Health System Pharmacists will attend the meeting on the 24th.

 

Regarding Mifegymiso's Bridging Study, the Central Pharmaceutical Review Committee also had a number of opinions on the exemption of Bridging Study, but it was not finally confirmed.

 

Currently, the Mifegymiso review has been requested to supplement the data, but the data has not been submitted yet.