South Korea’s pharmaceutical sector is strictly regulated. Companies that manufacture medicinal products must obtain a Medicinal Product Manufacturer (의약품제조업) license. Below is a concise overview of what it covers and who needs it.
What qualifies as a “medicinal product” in Korea?
Under Korean law, medicinal products include items listed in the Korean Pharmacopoeia or otherwise intended to diagnose, treat, or prevent disease in humans or animals, or to pharmacologically affect structure or function. Quasi-drugs, instruments, machines, and devices are excluded.
Which businesses require this manufacturing license?
Any business that manufactures medicinal products in Korea must obtain the license from the relevant local office of the Ministry of Food and Drug Safety (MFDS). In addition, manufacturers must secure product-level MFDS approval (marketing authorization) before sale. (This establishment license is distinct from other categories such as Narcotics Manufacturer.)
What does the license indicate about the business?
Holding a Medicinal Product Manufacturer license confirms that the company is legally authorized to manufacture medicinal products in Korea and that its facilities and quality systems comply with MFDS standards, including GMP for Medicinal Products. In practice, it is both a legal requirement and a marker of quality, safety, and regulatory compliance within the pharmaceutical industry.
Coverage in KOBDi: The KOBDi database includes businesses registered with a Medicinal Product Manufacturer (의약품제조업) license. This information appears on each Business Profile page, and companies with this license can be found via the KOBDi Korea Industry Search.