- Ministry of Health and Welfare — 보건복지부
Sets national health policy including controlled substance access. Extremely conservative stance on cannabis — among the most restrictive regimes globally. Criminal penalties for recreational use are severe.
- National controlled substance policy
- Oversight of MFDS cannabis decisions
- Patient access policy — extremely limited
- MFDS — Ministry of Food and Drug Safety (식약처)
Primary regulatory authority for pharmaceutical cannabis products. Only specific approved products (Epidiolex, Sativex) may be imported. No pathway for botanical cannabis or flower. Reviews all import authorization applications.
- Product-specific import authorization
- Only pharmaceutical-grade products approved
- No botanical/flower pathway
- Manufacturing and import licensing
- Korea Orphan Drug Center — KODC (희귀질환의약품센터)
KODC manages import of orphan and rare disease medicines, including cannabis-based pharmaceuticals for specific conditions. Primary pathway for patients accessing Epidiolex and similar products.
- Manages rare disease drug import program
- Coordinates with MFDS on product-specific authorization
- Hospital-based distribution only
- Hospital Pharmacies — 병원 약국
Cannabis-based medicines dispensed only through designated hospital pharmacies. No community pharmacy access. Strict controlled substance protocols.
- Designated hospital pharmacy only
- Specialist physician prescription required
- Controlled substance inventory and reporting
- Patients — Extremely limited access
Only patients with specific approved conditions (e.g., Dravet syndrome, Lennox-Gastaut syndrome for Epidiolex) may access cannabis-based medicines. All other cannabis use is criminalized.