Named-Patient Supply — South Korea

South Korea regulates the import and supply of medicines through the Ministry of Food and Drug Safety (MFDS). For drugs that are not approved or not marketed in Korea — including many orphan and rare-disease treatments — the country operates a dedicated pathway centred on the Korea Orphan & Essential Drug Center (KODA), the body responsible for importing and supplying orphan and other hard-to-obtain medicines so that patients in need can access them.

Because these medicines fall outside the standard domestic marketing-authorisation route, supply is arranged on a patient-specific basis with the involvement of the treating physician and the relevant authorities. The exact eligibility criteria, prescriptions, registration and import permissions that apply in any given case are determined by MFDS and KODA. GNH USA works within this framework as the international sourcing partner — locating a quality, regulator-approved source abroad and delivering it under documented, GDP-compliant conditions.

For patients and physicians, the practical challenge is rarely the regulation itself but finding the medicine. A treatment for a rare condition may be approved in only a handful of countries, held by a limited number of distributors, or in short supply. This is where an international distributor adds value: GNH USA maintains relationships across regulator-approved markets worldwide, so when a Korean prescription cannot be filled domestically, we can identify where the medicine is genuinely available, confirm its provenance, and prepare it for compliant import. Throughout, the named patient remains at the centre of the process, and the steps required by MFDS and KODA are respected at every stage.