MFDS to Commission Domestic Production of 3 Essential Medicines for Direct Supply

Three Anticancer and Antibiotic Products
Largest Number Since the Program Began in 2016

The government will directly commission domestic pharmaceutical companies to manufacture three anticancer drugs and antibiotics whose supply is unstable or has been interrupted. The medicines, which have previously been urgently imported from overseas or faced supply disruptions, are expected to be supplied to healthcare providers within the year.

Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. The Asia Business Daily archive.

On the 12th, the Ministry of Food and Drug Safety (MFDS) said it would commission domestic production through the Korea Orphan & Essential Drug Center for three anticancer and antibiotic products needed to treat hepatocellular carcinoma, acute myeloid leukemia, and severe bacterial infections. The products are Boryung's lyophilized doxorubicin injection, Korea United Pharm's daunorubicin injection, and Kunil Bio Pharm's daptomycin injection. Including the dacarbazine injection designated in the first half of this year, four products have been newly selected for commissioned production this year, the largest number since the program began in 2016.

Doxorubicin is used in transarterial chemoembolization for liver cancer patients, while daunorubicin is used to treat blood cancers, including acute myeloid leukemia. Daptomycin is essential for treating severe infections, including methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, which does not respond well to antibiotics. Doxorubicin and daptomycin have previously been urgently imported from overseas in response to requests from healthcare providers. Following a recent supply disruption of daunorubicin, it was proactively included in the program to prevent disruptions to treatment for conditions such as acute leukemia in children.

Under the commissioned production system, the government reimburses domestic pharmaceutical companies for production costs, and the center purchases all the medicines produced and supplies them. Currently, eight pharmaceutical companies produce 11 national essential medicines.

An amended Pharmaceutical Affairs Act containing the legal basis for commissioned production takes effect today. Under the amendment, the MFDS Commissioner may ask domestic pharmaceutical companies to manufacture national essential medicines that are difficult to supply reliably and pay the necessary costs. The law now supports a program that had previously been operated administratively, strengthening a government-led system for supplying essential medicines.

An MFDS official said, "We will work with the medical community, pharmaceutical industry, and relevant organizations to identify national essential medicines with unstable supplies early and expand support, including commissioned production. We will do our best to ensure patients receive essential treatments on time."

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