Supplying Medicines and Supplements to South Korea

South Korea runs its own full review through MFDS, one of the first WHO-listed authorities. Only a licensed Korean importer can bring medicines in, so your importer is effectively your licence holder. Every overseas plant behind a product, API sites included, must be registered before import, and from August 2026 the generic price depends on your own bioequivalence study and a registered DMF API.

For buyers, South Korea is a source of finished medicines, biosimilars and APIs made under KGMP, within the PIC/S system since 2014. MFDS inspects plants closely, at home and overseas, so Korean sites are used to detailed inspection. Ask any Korean exporter early which MFDS documents it can provide for your destination, and check what your own regulator accepts.

South Korea at a glance

How to supply medicines to South Korea

1. Choose your importer. Only a company with an MFDS import business licence can import medicines, and it holds the product approval. Agree in writing who owns the dossier. Our Japan, Korea, Australia and New Zealand guide explains each role.
2. Register every overseas site. Your importer must register each plant behind the product before the first import: finished products, DMF APIs and APIs for in-house use. MFDS uses the register to choose sites for on-site inspection and planned to double overseas inspections to 100 sites. Keep distribution records in order too.
3. Register the DMF and file the dossier. Imported new drugs need details of the API makers. MFDS said a GMP certificate from the producing country's authority or a PIC/S member authority would replace its own GMP evaluation for DMF APIs, cutting registration from 120 to 20 days. See our DMF guide and our dossier and registration service.
4. Price for the new generic rules. New drugs are assessed by HIRA and priced by NHIS. For generics, the base rate is now 45% of the original price; generics meeting only one of the two requirements get 36%, and those meeting neither get 29%. Our API sourcing service can help you find a registered DMF source.

For a needed medicine that is unavailable in South Korea with no domestic alternative, the Korea Orphan & Essential Drug Center buys and supplies it from overseas, and it also supports imports for individual patients, so doctors and hospitals should start there. See named-patient and special import and government tender supply.

Sourcing from South Korea

• Originator medicines and comparators. Medicines approved in South Korea are reviewed by a WHO-listed authority, which helps when a trial or a regulator asks for traceable comparators. Buy through the Korean licence holder or licensed channels and ask for batch certificates. See our comparator supply service and comparator sourcing guide.
• APIs and documents. Korean API makers work under KGMP and often hold a Korean DMF. If you need a CEP or a US DMF, ask early whether one exists. Our CEP vs DMF vs ASMF guide and API sourcing service cover what to ask for.
• Contract manufacturing and biosimilars. Korean plants make small-molecule medicines and biosimilars, and MFDS inspects them on site. Check the GMP history and the scope of each site before you sign. See our CDMO guide and white-label manufacturing.
• Export documents. Ask the Korean exporter which MFDS-issued documents it can provide, such as a certificate of pharmaceutical product or GMP evidence, and confirm your own regulator accepts them. See our CoPP guide and documentation and quality pack.

Supplements

Supplements are sold as health functional foods, regulated by MFDS under the Health Functional Food Act. Each functional ingredient must either be notified in MFDS's standards or individually recognised by MFDS for one business only. Overseas plants must be registered with MFDS before the import declaration and can be inspected on site, so keep disease claims off the pack and your plant file current. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What people in South Korea search for

Semrush data from October 2026 shows that people in South Korea search most for 비타민 (vitamins, about 22,200 searches a month), 비타민 c and 비타민 d (vitamin C and vitamin D, 18,100 each), and 멀티 비타민 and 종합 비타민 (both meaning multivitamin, 12,100 each).

Koreans search in Korean and by nutrient: 오메가3 (omega-3) gets about 8,100 searches a month and msm about 3,280. Medicine searches are mostly about how a drug is given, such as “intrathecal” (480) and “intravenous” (320), rather than generic names.

How importers, pharmacies and manufacturers in South Korea search

Trade searches are in English and centre on private label work: “private label” gets about 110 a month, “private label brands” 90 and “private label cosmeceuticals” 30.

Supplements we can help you make

Often searched medicines are few next to vitamins and omega-3. South Korean plants make biosimilars of trastuzumab, rituximab and bevacizumab. Some examples we list:

한국어판: 일본·한국·호주·뉴질랜드 의약품 수입 가이드: 국가별 안내 (2026)

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Japan, South Korea, Australia and New Zealand import guide.

Frequently asked questions