MFDS Newly Designates 8 National Essential Medicines, Including Treatments for Newborns and Cancer Patients

Designation scope adjusted for seven existing products

The government has newly designated eight products, including medicines used to treat newborns and cancer patients, as National Essential Medicines. The move is intended to ensure a stable government-managed supply of medicines that are vital to medical care but whose supply cannot be secured reliably through market forces alone.

A view of the Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. The Asia Business Daily DB

On October 20, the Ministry of Food and Drug Safety said it had newly designated eight products (ingredients and dosage forms) as National Essential Medicines after holding a meeting of the Council for the Stable Supply of National Essential Medicines from October 6 to 8. National Essential Medicines are medicines essential for healthcare, including disease management and radiation emergency preparedness, but whose stable supply is difficult to ensure through market forces alone. They are designated through interagency consultations in accordance with Article 2(19) of the Pharmaceutical Affairs Act.

The products newly designated this time include ▲daunorubicin injections, used to treat acute myeloid leukemia and acute lymphoblastic leukemia; ▲porcine lung extract injections, used to treat neonatal respiratory distress syndrome; and ▲multi-amino acid infusion solutions (6% and 10%), used to provide amino acids to infants and young children with poor nutritional status.

The designation details for seven previously designated products were revised. For rotavirus vaccines, human papillomavirus (HPV) vaccines, pneumococcal vaccines, and baclofen injections, designations that had been divided by specific types, such as monovalent and pentavalent or bivalent, quadrivalent, and nonavalent, were consolidated. The scope of the designation for amphotericin B injections was expanded to include liposomal injections, and invasive fungal infections were added as an indication.

"Medicines used to treat newborns and cancer patients must be supplied reliably to medical facilities, so they need to be designated as National Essential Medicines and managed as a priority," said MFDS Deputy Minister Kim Yongjae. "We will actively support the smooth supply of National Essential Medicines, including the products designated this time."

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