MFDS Switches 10 Overseas Self-Treatment Medicines to Emergency Import

[Financial News] The Ministry of Food and Drug Safety has converted 10 rare and essential medicines that patients previously purchased directly from overseas into medicines supplied directly by the government through the emergency import system. This measure is intended to expand the public supply system for medicines that are difficult to supply domestically but essential for patient treatment.
The Ministry of Food and Drug Safety announced on the 14th that it had begun expanding emergency-import medicines as a follow-up measure to the 'Plan to Strengthen Support for Rare and Severe Intractable Diseases.'
The Emergency Drug Import System is a system through which the government directly supplies foreign medicines that have not been approved domestically via the Korea Center for Rare and Essential Medicines, taking into account factors such as their necessity in medical settings and the possibility of substituting other medicines.
The medicines converted to emergency imports are products that patients previously purchased overseas for self-treatment and brought into the country through the Korea Center for Rare and Essential Medicines. Among them, the Ministry of Food and Drug Safety selected 10 products for which direct government supply was necessary because of their high importance in medical settings or the large volume imported into Korea.
The major products include rifampicin (rifampin) injections, used for severe tuberculosis patients who have difficulty taking oral medication. Tiopronin tablets, which prevent stone formation in patients with cystinuria, and Hydroxocobalamin injections, used for patients with confirmed or suspected cyanide poisoning, were also included.
Levothyroxine injections, used to treat myxedema coma caused by severe hypothyroidism, and Tobramycin inhalants, used to treat Pseudomonas aeruginosa infections in patients with cystic fibrosis, have also been converted to emergency-import products.
The Ministry of Food and Drug Safety is also pursuing the designation of new emergency-import medicines for products whose supply to medical facilities has become difficult because pharmaceutical companies withdrew them or suspended their supply. This measure is intended to resume supply in the field based on requests from the medical and pharmaceutical sectors, as well as professional societies and organizations. The resumption of supply is currently being pursued for four products, including Cisatracurium injections and axatilimab injections.
The public supply system for medicines with unstable supplies will also be strengthened legally. When the revised Pharmaceutical Affairs Act takes effect this November, a legal basis will be established for carrying out public supply tasks, such as emergency imports and on-demand manufacturing, for medicines with unstable supplies.
Based on this, the Ministry of Food and Drug Safety plans to improve access to treatment for patients who need essential medicines, including those with rare and severe intractable diseases, and reduce gaps in medicine supplies.

[email protected] Jeong Sang-hee Reporter