The government will commission domestic pharmaceutical companies to produce three essential anticancer and antibiotic drugs whose supply has been unstable, aiming to deliver them to medical facilities within the year. An amended Pharmacy Act, which allows the state to request the production of essential medicines from pharmaceutical companies and provide necessary funding, has also taken effect, establishing a legal foundation for stable medicine supply.
The Ministry of Food and Drug Safety announced on the 12th that it is promoting domestic commissioned manufacturing of three anticancer and antibiotic drugs required for treating hepatocellular carcinoma, acute myeloid leukemia, and severe bacterial infections, with plans to supply them within the year.
The targets for this commissioned manufacturing are Bora Pharmaceutical's "Admycin Lyophilized Injection" (active ingredient: doxorubicin), Korea United Pharmaceuticals' "Daunorubicin Injection" (daunorubicin), and Geonil Biopharm's "Daptomycin Injection" (daptomycin).
Doxorubicin lyophilized injection is used for transarterial chemoembolization in patients with hepatocellular carcinoma. Daunorubicin injection is used for treating blood cancers such as acute myeloid leukemia, while daptomycin injection is used for treating severe infections such as bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA).
The Ministry of Food and Drug Safety and the Korea Rare and Essential Medicines Center have transitioned doxorubicin and daptomycin injections, which had previously been urgently imported from overseas in response to requests from medical facilities, to domestic commissioned manufacturing targets. Daunorubicin injection, whose supply was recently interrupted, has also been included as a commissioned manufacturing target to prevent treatment gaps for conditions such as pediatric acute leukemia.
Commissioned manufacturing of national essential medicines is a program in which the government supports domestic pharmaceutical companies in producing medicines that have had their supply interrupted or are at risk of interruption. The program operates by compensating domestic pharmaceutical companies for production costs, with the Korea Rare and Essential Medicines Center purchasing all manufactured medicines to supply them to medical facilities.
The Ministry of Food and Drug Safety has operated this program through the Korea Rare and Essential Medicines Center since 2016. Following the addition of Korea United Pharmaceuticals' anticancer drug "DTI Injection" (dacarbazine) as a commissioned manufacturing target in the first half of this year, the selection of these three items brings the total number of new targets for this year to four. This marks the largest annual increase in newly included items since the program's implementation.
In particular, the amended Pharmacy Act taking effect on this day establishes a legal basis for commissioned manufacturing of national essential medicines. Under the amended law, the Minister of Food and Drug Safety may request domestic pharmaceutical companies to manufacture national essential medicines that are difficult to supply stably and pay the necessary costs.
With the commissioned manufacturing program, which had been operated administratively until now, explicitly stated in law, an institutional foundation has been established to link the production capacity of domestic pharmaceutical companies with the government's public procurement and supply functions. The relevant provisions are included in Article 83-6 of the Pharmacy Act, amended on May 26.
The Ministry of Food and Drug Safety plans to cooperate with the medical community, the pharmaceutical industry, and related agencies to identify national essential medicines with unstable supply early and expand support for domestic commissioned manufacturing. Currently, eight pharmaceutical companies, including Bora Pharmaceutical, Yuhan Corporation, Korea United Pharmaceuticals, and Huons, are participating in the national essential medicine commissioned manufacturing program, with a total of 11 items designated as targets.
in THEBIO
