Government to Directly Supply 10 Essential Medicines Patients Previously Had to Import Themselves

Four Additional Drugs Designated as Emergency Import Medicines

Going forward, the government will directly supply 10 essential medicines that patients previously had to import themselves from overseas for treatment. In addition, four medicines that have become difficult to obtain in clinical settings—due to withdrawal or supply suspension by pharmaceutical companies—have also been newly designated as candidates for emergency importation.

Food and Drug Safety Administration building in Cheongju, Chungbuk. The Asia Business Daily DB

On the 14th, the Ministry of Food and Drug Safety announced plans to expand its public supply system for medicines that are essential for patient care but are not supplied through the domestic private market. This is a follow-up measure to the "Strengthening Support for Rare and Severe Intractable Diseases Plan" announced in January.

Previously, patients personally purchased and imported medicines from overseas for self-treatment via the Korea Orphan & Essential Drug Center. From among these drugs, the government has re-designated 10 items—considered highly essential in medical settings or frequently imported into Korea—as "emergency imported medicines."

The emergency import system allows the government to supply drugs directly through the Korea Orphan & Essential Drug Center, considering the necessity in clinical practice and the possibility of substitution with other treatments, even if the foreign medicine is not authorized in Korea.

Among the medicines re-designated for emergency import are: injectable rifampicin (Rifampin), used in severe tuberculosis cases where oral administration is difficult; tiopronin tablets, which prevent stone formation in patients with cystinuria; hydroxocobalamin injections for the treatment of cyanide poisoning; treosulfan injections used in preparative regimens for hematopoietic stem cell transplantation; and labetalol tablets for hypertension and pregnancy-induced hypertension, among others.

The scope of emergency imports will also be expanded for medicines that are now difficult to supply due to product withdrawals or supply suspensions by pharmaceutical companies. Based on requests from the medical and pharmaceutical fields, as well as specialized academic societies and organizations, the Ministry of Food and Drug Safety has decided to newly recognize four medicines as emergency imported medicines.

The additional medicines include cisatracurium injectable, used for skeletal muscle relaxation during general anesthesia or sedation of critically ill patients, and axatilimab injectable, used to treat chronic graft-versus-host disease.

The institutional foundation of this public supply system will be further strengthened in the future. When the revised Pharmaceutical Affairs Act, which was amended in May, comes into effect on November 12, it will provide a legal basis for the government to urgently import or custom-manufacture essential medicines for the country in cases of unstable supply.

This content was produced with the assistance of AI translation services.