Hyundai Pharm made it official that it will supply Mifegyne, an abortive drug, in Korea. Industry watchers said the supply could open ways for medication abortion.

However, as the company is preparing for the regulator’s preliminary review before seeking the nod, it will take a considerable time until a pregnant woman gets a Mifegyne prescription, observers said.

On Tuesday, Hyundai Pharm said it has signed an exclusive agreement with Linepharma International to sell oral Mifegyne in the local market. Established in 2010 in France by a team that developed Mifezone (ingredient: mifepristone), Linepharma distributes Mifegyne in Canada, South America, and the Asia Pacific.

Hyundai Pharm said the upcoming drug for the Korean market would be a combination drug of mifepristone and misoprostol.

After the Constitutional Court ruled in April 2019 that the domestic law banning all abortion was unconstitutional, the government revised laws to allow medication abortion.

However, in reality, the popular abortion drug Mifegyne has been unavailable.

Civic groups demanded the government introduce an abortion drug. However, the Ministry of Food and Drug Safety (MFDS) said it would be difficult to do so unless a pharmaceutical company wants to supply it. Unable to get Mifegyne, some people purchased it through illegal online trading, raising safety concerns over counterfeit drugs.

Last month, the Association of Pharmacists for Healthy Society (APHS) issued a statement, saying, “Given the fact that an internet search with the keyword Mifegyne leads to so many online sites that provide direct purchase services overseas, we can predict that the demand for Mifegyne is significantly high.”

Therefore, the nation urgently needs to introduce Mifegyne to secure women’s reproductive and health rights, the group added.

In February, the MFDS caught 188 online sites that promoted Mifegyne as if users could purchase them through consultation with doctors.

“There are many cases of illegal purchase of abortive drugs on the internet, which could cause serious side effects due to inaccurate information about the dosage and regimen, and contraindications,” an official at Hyundai Pharm said.

The company decided to provide the local supply of abortive medicine to help women access safe medication abortion, he added.

Hyundai Pharm said it was discussing the introduction of the miscarriage-inducing medicine with manufacturer Linepharma and the MFDS. Hyundai Pharm plans to distribute it as a prescription drug.

The MFDS has begun the process for a preliminary review of the abortive drug. The preliminary assessment usually takes about 60 business days, and industry watchers expect that the approval review procedure will start in the second half.

“We are pleased to work with Hyundai Pharma, the leader in the obstetrics and gynecology field. By this, we can supply Linepharma’s safe abortion medicine,” an official at Linepharma said.

The official at Hyundai Pharm said the company would submit a new drug application as quickly as possible.

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