South Korea Expands Emergency Import Program to 14 Unlicensed Essential Medicines
核心洞察
South Korea's Ministry of Food and Drug Safety (搜索) will move 10 medicines previously imported by patients themselves into a government-run emergency import program.
The converted items include rifampicin injection for severe tuberculosis (搜索), tiopronin tablets for cystinuria (搜索) and hydroxocobalamin injection for cyanide poisoning (搜索).
Four additional drugs were added after companies withdrew them or halted supply, including cisatracurium injection and axatilimab injection for chronic graft-versus-host disease (搜索).
South Korea's Ministry of Food and Drug Safety (搜索) (MFDS) is converting 10 medicines that patients had been importing on their own — including a treatment for severe tuberculosis (搜索) — into a government-supplied "emergency import" program, and has added four more drugs that became difficult to obtain after companies withdrew them or halted supply. The ministry announced the measure on the 14th as a follow-up to the government's plan, announced in January this year, to strengthen support for rare and severe intractable diseases.
Government Takes Over the Supply Chain
The emergency import program allows the government to supply directly, through the Korea Orphan & Essential Drug Center (搜索), overseas medicines that are not licensed in South Korea but are essential to treatment and difficult to replace with other drugs. Under the previous approach, patients had to obtain overseas medicines individually; under the new arrangement, the government manages the supply chain.
The 10 converted items were drawn from medicines that patients had been buying and bringing in from overseas for self-treatment through the Korea Orphan & Essential Drug Center (搜索), with the ministry selecting those in high demand at medical sites or imported in large volumes.
Rifampicin, Tiopronin and Other Converted Therapies
The converted items include rifampicin injection, used for patients with severe tuberculosis (搜索) who cannot take oral medication; tiopronin tablets, which prevent stone formation in patients with cystururia; hydroxocobalamin injection, a treatment for cyanide poisoning (搜索); and levothyroxine injection, used to treat coma caused by severe hypothyroidism (搜索). Tobramycin inhalation solution, used to treat Pseudomonas aeruginosa infections in patients with cystic fibrosis (搜索), is also on the list.
Treosulfan injection, used in conditioning before hematopoietic stem cell transplants, the hypertension (搜索) drug labetalol, and phentolamine injection, used for conditions such as pheochromocytoma (搜索), will also be converted, bringing the total number of converted items to 10.
Four Drugs Added After Withdrawals and Supply Halts
Drugs whose domestic supply has been halted or whose licenses have been withdrawn are also included in the program. The ministry added four items that have become hard to obtain at medical sites because of product withdrawals or supply halts by pharmaceutical companies: cisatracurium injection, axatilimab injection, epoprostenol injection and hydrocortisone injection.
Cisatracurium is used to relax muscles during general anesthesia or sedation of critically ill patients, while axatilimab treats chronic graft-versus-host disease (搜索) that can develop after hematopoietic stem cell transplants.
Legal Basis Strengthened From November
The institutional basis for public supply of essential medicines will also be strengthened. When the revised Pharmaceutical Affairs Act takes effect in November, it will provide a legal basis for emergency imports and made-to-order manufacturing of national essential medicines with unstable supply. Based on this, the ministry plans to expand public supply of drugs that the private sector cannot provide reliably.
The expansion reflects a broader shift in how Korea handles unlicensed but medically necessary treatments. Separately, the MFDS maintains a pathway for patients to obtain certain cannabis-based or other controlled medicines for medical treatment, particularly when no domestic alternative is available — cases that can involve additional approval procedures and, in some circumstances, the Korea Orphan & Essential Drug Center (搜索). Travelers bringing controlled narcotic or psychotropic medications into Korea for personal treatment must obtain MFDS approval regardless of nationality, a requirement in place since 2009, with online applications available through the ministry's Drug Safety Korea website since Dec. 27, 2024.