South Korea Moves 10 Self-Imported Medicines Into Government Emergency Import Program
核心洞察
South Korea's Ministry of Food and Drug Safety (搜索) will directly supply 10 medicines patients previously imported themselves, including rifampicin injection for severe tuberculosis (搜索).
Four additional drugs that became hard to obtain after company withdrawals or supply halts were newly designated for emergency importation.
The program, run through the Korea Orphan & Essential Drug Center (搜索), covers unlicensed but essential medicines that are difficult to replace.
South Korea's Ministry of Food and Drug Safety (搜索) (MFDS) announced on the 14th that it will shift 10 medicines that patients had been importing on their own into a government-supplied "emergency import" program, and has newly designated four additional drugs that have become difficult to obtain at medical sites. The measure follows up on the government's plan to strengthen support for rare and severe intractable diseases announced in January this year.
Under the emergency import system, the government supplies medicines directly through the Korea Orphan & Essential Drug Center (搜索). It applies to overseas medicines that are not licensed in South Korea but are essential to treatment and difficult to replace with other drugs. Unlike the previous approach, in which patients had to obtain overseas medicines individually for self-treatment, the government now manages the supply chain, taking into account clinical necessity and the possibility of substitution with other treatments.
Ten Converted Medicines
The 10 items converted from patient self-importation were selected from drugs that are in high demand at medical sites or are imported in large volumes. They 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 cystinuria (搜索); 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. The total number of converted items is 10.
Four Drugs Added After Supply Disruptions
The ministry also added four items that have become hard to obtain at medical sites because of product withdrawals or supply halts by pharmaceutical companies. These include cisatracurium injection, used to relax muscles during general anesthesia or sedation of critically ill patients, and axatilimab injection, which treats chronic graft-versus-host disease (搜索) that can develop after hematopoietic stem cell transplants. Epoprostenol injection and hydrocortisone injection were also newly recognized as emergency imported medicines.
The ministry said the additions were based on requests from the medical and pharmaceutical fields, as well as specialized academic societies and organizations.
Legal Basis Takes Effect in November
The institutional basis for public supply of essential medicines will be strengthened when the revised Pharmaceutical Affairs Act, amended in May, takes effect on November 12. The revision will provide a legal basis for the government to urgently import or custom-manufacture national essential medicines in cases of unstable supply. Based on this, the ministry plans to expand public supply of drugs that the private sector cannot provide reliably.