MFDS says, abortion drug approval cannot be reviewed

"Amendment to the law must be established first"

The efficacy, dosage, etc., can only be set once medication-induced abortion are clearly defined by law

Hyundai Pharm agrees with the current situation…filed a marketing authorization application in December 2024

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Hyundai Pharm filed a marketing authorization application for oral abortion drug 'Mifegymiso Tab (mifepristone·misoprostol)' last year.

 

However, it has been confirmed that, under the current state of legislative void, the review cannot even begin.

 

On the 30th, the Ministry of Food and Drug Safety's (MFDS) Pharmaceutical Approval Management Division responded to an inquiry from specialized journalists, stating, "The review of Mifegymiso Tab can only commence once a legal basis is established, and currently, review is not possible." They added, "Hyundai Pharm also understands that the efficacy, indications, dosage, and administration, etc., can only be set once the allowance and permissible gestational age for medication-induced abortion are clearly defined by law." Mifegymiso is a drug that induces early pregnancy termination.

 

It is already used in over 90 countries, including the United States and France, since the World Health Organization (WHO) designated it as an 'essential medicine' in 2005.

 

In South Korea, Hyundai Pharm signed an exclusive supply agreement with LinePharma UK and submitted its third marketing authorization application in December 2024, following previous submissions in 2021 and 2023.

 

The two previous applications were voluntarily withdrawn due to requests for supplementary data.

 

An MFDS official explained, "The establishment and review of key assessment items, such as efficacy, effect, dosage, administration, and Risk Management Plan, are only possible once the allowance and permissible gestational age for medication-induced abortion are legally defined." They added, "Hyundai Pharm is also aware of this and has agreed through internal discussions that it is difficult to proceed with approval at this time." Under the current legal framework, only surgical abortion methods are permitted, and medication-induced termination lacks a legal basis.

 

Although the Constitutional Court of Korea ruled the abortion ban unconstitutional in 2019, amendments to the Criminal Act and the Mother and Child Health Act have not yet been made, leading to an ongoing legislative void.

 

Consequently, MFDS has not yet taken official action, such as refusing approval or suspending review, for Mifegymiso Tab.

 

It is being formally managed as 'under review.' The official emphasized, "Internal discussions regarding alternative methods, such as conditional approval or restricted use, have not reached a feasible level." The MFDS's position is that it cannot make a judgment alone, as this is an issue that requires prior social consensus, possibly in the form of legal amendments.

 

Hyundai Pharm announced the submission of the Mifegymiso marketing authorization application through a public disclosure on December 31 last year.

 

The disclosure contained results from three clinical trials conducted in the U.S.

 

and Mexico, where Mifegymiso showed abortion success rates of 94.9%, 96.2%, and 97.3%, respectively.

 

Hyundai Pharm explained that these study results demonstrate the effectiveness of the regimen, which involves taking 200mg of oral mifepristone followed by 800mcg of misoprostol, for terminating pregnancies up to 63 days (9 weeks) of gestation.

 

Mifegymiso is a combipack product consisting of one 200mg mifepristone tablet and four 200mcg misoprostol tablets.

 

The method involves first taking mifepristone, which inhibits the action of progesterone (essential for maintaining pregnancy), and then, 1-2 days later, taking misoprostol, which promotes uterine contractions.

 

This is the method for medical abortion up to 63 days (9 weeks) of gestation recommended by the WHO.

 

An official from Hyundai Pharm stated, "There have been no new updates since the marketing authorization application in December 2024." They added, "We are striving to introduce a safe and effective drug based on the results of three clinical trials conducted in the U.S.

 

and Mexico." Meanwhile, in April 2019, the Constitutional Court of Korea ruled the criminal code's abortion ban unconstitutional, citing respect for women's right to self-determination over their bodies.

 

Consequently, abortion procedures became de facto legalized as of January 1, 2021.

 

In the 21st National Assembly, a total of seven bills related to the abolition of the abortion ban, including amendments to the Criminal Act and the Mother and Child Health Act, were proposed but ultimately expired without proper discussion.

 

In the 22nd National Assembly, Democratic Party of Korea lawmakers Nam In-soon and Lee Su-jin recently proposed amendments to the Mother and Child Health Act.