MFDS Expands Public Supply of Essential Medicines, Urgently Importing 14 Products

The Ministry of Food and Drug Safety (MFDS) has expanded the public supply system for medicines that are essential to patient treatment but are not supplied by the private sector.

On the 14th, MFDS said it had increased public supply through its urgent-import system as a follow-up measure to its “Plan to Strengthen Support for Rare and Severe Intractable Diseases.”

Under the urgent-import system, the government directly supplies medicines not approved in South Korea through the Korea Orphan & Essential Drug Center, taking into account their necessity in clinical practice and the availability of alternatives.

MFDS has shifted 10 products to urgent-import status from among those that patients had previously needed to purchase overseas medicines through the Korea Orphan & Essential Drug Center for personal treatment and bring them into the country.

The products include rifampicin injections for tuberculosis treatment, tiopronin tablets used to prevent stones in patients with cystinuria, and hydroxocobalamin injections for cyanide poisoning.

The list also includes levothyroxine injections for treating myxedema coma and tobramycin inhalation products for treating cystic fibrosis.

MFDS also recognized four additional products for urgent import, based on requests from health care and pharmaceutical professionals and specialist societies and organizations, for medicines that had become difficult to supply in clinical settings because manufacturers withdrew them or stopped supplying them.

The additional products are cisatracurium injections, used for skeletal muscle relaxation during general anesthesia; axatilimab injections, a treatment for chronic graft-versus-host disease; epoprostenol injections, a treatment for pulmonary arterial hypertension; and hydrocortisone injections, used to treat acute conditions such as adrenocortical insufficiency.

MFDS said that amendments to the Pharmaceutical Affairs Act taking effect in November this year will establish a legal basis for public supply activities, including urgent imports and made-to-order manufacturing of medicines with unstable supply, and that it will continue working to protect patients’ right to treatment.