The Ministery of Food and Drug Safety said on the 2nd that it newly designated three products, including a malignant melanoma treatment, an anticancer drug for hepatocellular carcinoma, and a muscle relaxant for anesthesia, as national essential medicines.
The move is intended to strengthen support for medicines that are essential in clinical settings but need stable supply management due to unstable supply.
The newly designated items are three types: dacarbazine injection used for malignant melanoma and Hodgkin lymphoma; doxorubicin injection (lyophilized) used in transarterial chemoembolization (TACE) for hepatocellular carcinoma; and cisatracurium injection used for muscle relaxation during anesthesia and endotracheal intubation.
National essential medicines are drugs that are needed for disease treatment and maintaining public health but may have unstable supply due to low demand or production and distribution conditions. The government designates items through a pan-ministerial consultation and supports stable supply.
With this designation, the number of national essential medicines increased from 488 items to 491.
The Ministery of Food and Drug Safety can conduct expedited reviews for product approvals and variation approvals and provide administrative and financial support for items designated as national essential medicines.
In addition, the National Essential Medicines Stable Supply Council updated the ingredient names or indication labels of four items—dextromethorphan/quinidine capsules, hemin injection, and haloperidol tablets and injection—to align with the latest medical terminology.
Kim Yong-jae, Vice Minister of the Ministery of Food and Drug Safety, said, "We swiftly designated anticancer injections and other drugs urgently needed for stable supply in clinical settings as national essential medicines," and added, "We will do our best to create an environment where cancer patients can use medicines without supply instability."
Meanwhile, the National Essential Medicines Stable Supply Council is a statutory consultative body established in 2016, with 10 central administrative agencies participating, including the Office for Government Policy Coordination, the Ministry of Health and Welfare, and the Korea Disease Control and Prevention Agency.