Hyundai Pharm applied for approval to market abortion pill

Hyundai Pharmaceutical revealed on Tuesday, July 6, that it has submitted an application so it can start selling its abortion pill in South Korea. The company filed for authorization to market at the Ministry of Food and Drug Safety.

Hyundai Pharm is intending to start selling its Mifegymiso that is composed of four tablets of misoprostol and one tablet of mifepristone. Mifepristone is being sold in Korea under the brand name Mifegyne.

First legal abortion pill in S. Korea

According to The Korea Herald, if the ministry will give a go signal for the sale of Mifegymiso, it would effectively become the very first abortion pill that will be legally marketed in the country. In 2019, the Constitutional Court reversed the ban on abortion in the first 14 weeks of pregnancy, so this paved the way for the pills to be produced.

Hyundai Pharm will be distributing Mifegymiso to the market as a prescription drug. This means that only patients with proper medical advice from health professionals will be able to obtain the drug. Without the supervision of a certified health advisor, an individual will not be allowed to purchase the abortion pill.

The U.S. Food and Drug Administration stated that abortion pills are safe to use in the first nine or 10 weeks of pregnancy. While it seems that more and more groups are supporting and even promoting abortion pills, it was reported that the National Assembly is working on revising the Pharmaceutical Affairs Act so it can bar the advertising of the drug.

The marketing license for Mifegymiso

Korea Biomedical Review reported that Hyundai Pharm’s filing for approval for the abortion drug has gained attention because the Ministry of Health and Welfare already granted repayment for doctor’s education and counseling sessions about medical abortion.

The policy asks doctors to give educational counseling to pregnant women regarding abortion. They are allowed to explain the procedures for abortion, including precautions before and after the surgery. The physicians will also be taught about the physical and mental complications of abortion and contraception.

Meanwhile, Hyundai Pharm stated it will do its best to gain approval. “We will closely work with the drug developer to accelerate the regulatory nod for the drug,” a company official said.