The South Korean government has designated eight additional drug ingredients and formulations as nationally essential medicines, including treatments for neonatal respiratory distress syndrome and acute myeloid leukemia. The aim is to bring products that are indispensable in clinical settings, but difficult to supply reliably through market forces alone, under intensive government management.
The Ministry of Food and Drug Safety said on the 20th that it had posted public notice on the 19th of the eight new designations, following a review by the Council on the Stable Supply of Nationally Essential Medicines. Under the program, drugs deemed essential for public health — covering disease management and radiological emergency response, among other areas — but hard to secure through the market alone are designated through consultation across government ministries.
The newly designated products include daunorubicin injections used to treat acute myeloid leukemia and acute lymphoblastic leukemia, and porcine lung extract injections used for neonatal respiratory distress syndrome. Also added were compound amino acid intravenous solutions, used to supply amino acids to undernourished infants and young children, and compound lipid intravenous solutions for treating essential fatty acid deficiency.
Other additions were ferric hydroxide complex syrup for iron deficiency anemia in infants and premature babies, sildenafil citrate 20-milligram tablets for pulmonary arterial hypertension, caffeine citrate oral solution for apnea of prematurity, and hydrochlorothiazide tablets for hypertension.
The ministry also adjusted the designated scope of seven medicines already on the list. Rotavirus vaccines, human papillomavirus (HPV) vaccines and pneumococcal vaccines were reorganized from designations by specific type into designations by vaccine group. Amphotericin B injections were broadened to cover invasive fungal infections as well as leishmaniasis, while the designated purpose of favipiravir tablets was changed from Ebola to severe fever with thrombocytopenia syndrome (SFTS) virus infection.
Starting next month, the government will also overhaul how the supply council operates. The council, currently led by the government, will be expanded and restructured into a joint public-private body that includes organizations involved in production, imports, distribution, prescribing, dispensing and use.
"A stable supply of medicines for newborns and cancer patients to clinical settings is essential," said Kim Yong-jae, vice minister of the Ministry of Food and Drug Safety. "We will actively support efforts to ensure that nationally essential medicines, including the products designated this time, are supplied smoothly."