[Reporter’s View] 1st oral abortion pill approval difficult

in Korea

A year has passed since the decriminalization of the abortion ban has taken effect.

 

The Korean Health and Medical Workers’ Union distributed a press release on the 11th on ‘ensuring safe abortion of the people 1 year after the decriminalization of abortion in Korea.’ The press release contained the request for marketing authorization of the oral abortion inducer Mifegymiso (Mifepristone·Misoprostol) and the preparation of an alternative legislation following the decriminalization of abortion under the criminal law in Korea.

 

On April 11, 2019, the Constitutional Court made a constitutional discordance adjudication on the provision on abortion under the Criminal Act.

 

The ruling took effect on January 1st, 2021, after which Hyundai Pharm applied for the marketing authorization of Mifegymiso in July of that year.

 

Hyundai Pham has signed an exclusive marketing and distribution agreement for the supply of Mifegymiso in Korea with the UK-based Linepharma International.

 

The drug is being used in 75 countries after the World Health Organization designated the drug as an essential medicine in 2005, The Ministry of Food and Drug Safety had assured expedited review of the drug to Hyundai Pham before the company applied for the marketing authorization of Mifegymiso.

 

Since then, the drug went through a preliminary review process for 4 months from February last year, during which it was implied that the drug may be commercialized within the year with an expedited review.

 

The Mifegymiso that Hyundai Pharm applied for is a combination pack that contains one 200mg Mifepristone tablet and four Misoprostol 200ug tablets.

 

10 months have passed since the marketing approval, but there is still no news of its approval in Korea, with the drug still under review.

 

The MFDS is known to have requested supplementary data to Hyundai Pharm in the review process, but the company requested a postponement of the deadline for submitting supplementary data, which has rendered the approval schedule unpredictable.

 

In addition, the need to create a legislative environment in which abortion drugs can be used stably was emphasized.

 

As controversies continue to arise over the approval of the abortion drug, the MFDS is having trouble promptly proceeding with the approval of the product.

 

In November last year, the MFDS and MOHW held an expert advisory meeting on the issue, but the meeting ended fruitlessly due to strong objections by obstetricians and gynecologists.

 

While civic groups are urging for the prompt approval of Mifegymiso, the medical community, mainly the Korean Association of Obstetricians and Gynecologists, is pointing out the dangers of Mifegymiso and insisting that it must undergo a bridging study in accordance with the principle of drug introductions in Korea.

 

In addition, it seems difficult for domestic pharmaceutical companies to expedite the marketing of abortion drugs in the absence of revisions to legislation such as the Criminal Act and Maternal and Child Health Act that would contain specific conditions and regulations for allowing abortions.

 

Ultimately, it seems that the approval of the first abortion drug in Korea will not be granted until all controversies in legislation and safety are revised and resolved.