Importing pharmaceuticals into Korea: the regulatory route for foreign companies

Foreign pharmaceutical companies arrive in Korea in three ways. A mid-sized European or American manufacturer appoints a Korean partner that registers and sells its products. A larger group sets up a Korean subsidiary that holds the licences and runs medical affairs, often while outsourcing warehousing and distribution. And specialty and orphan-drug companies, increasingly, use a licence-holding service company while they test the market. All three are built on the same legal fact: under the Pharmaceutical Affairs Act, the importer is a Korean business, and the importer — not the manufacturer abroad — is the person MFDS regulates.

This guide covers drugs for human use. Quasi-drugs, health functional foods, cosmetics and medical devices each have their own regime; the route finder below shows which applies, and our guide to cosmetics and food regulation covers two of them.

Who may import: the Korean licence holder

A person who imports drugs as a business must file an import business report (의약품 수입업 신고, uiyakpum suibeop singo) with MFDS under Article 42 of the Pharmaceutical Affairs Act and must obtain approval or file a notification for each product. The importer needs an office and the facilities the rules require — a warehouse and access to testing — and Article 42 applies to importers the rules on managers written for manufacturers. Under the Enforcement Rule on the Safety of Drugs, the importer must appoint at least one pharmacist (약사, yaksa) — or a Korean-medicine pharmacist — as import manager (수입관리자, suip gwallija), who may not take on duties outside that role. Breaches can lead to suspension of all imports and, for some, criminal penalties.

The consequence is structural. The foreign manufacturer cannot hold a Korean approval itself. Someone in Korea holds it, and that someone has three possible identities:

The three ownership models for Korean drug approvals.

Most of the disputes we see start with the first model. A distributor registers products in its own name, builds the market, and when the foreign company wants to change partners or set up its own subsidiary, the approvals stay where they are. Moving an approval requires either the holder’s cooperation in a transfer filing or a fresh application by the new importer — with the market interruption that implies. If you use a distributor, write the transfer obligation, the timetable and the data you will receive into the contract before the first dossier is filed. The same applies to the Korea Drug Master File (원료의약품 등록, wollyo uiyakpum deungnok) for your active ingredient, registered under Article 31-2.

Foreign manufacturing sites

Since 12 December 2019 an importer must register each foreign site that makes the drugs it imports, submitting a summary of the site’s staff, facilities, manufacturing and quality control, and must update the registration when anything changes. MFDS can inspect foreign sites; it gives the importer, the site and the exporting country’s government twenty days’ notice of the scope, period and inspectors. Findings can lead to an import suspension or cancellation of the registration.

In practice MFDS assesses GMP before approval for most products, often by document review backed by certificates from regulators it trusts — Korea has been a member of the Pharmaceutical Inspection Co-operation Scheme since 2014 and of the ICH since 2016 — and by on-site inspection where it sees risk. Plan the site master file, recent inspection reports and the batch documentation in English before filing; supplementary GMP requests are one of the main reasons the review clock stops.

Product approval and notification

Each product needs a product approval (품목허가, pummok heoga) or, for well-established products that meet published standards, a product notification (품목신고, pummok singo). The dossier follows the ICH Common Technical Document. New drugs need full quality, non-clinical and clinical data, including data on Korean or East Asian patients where ethnic factors matter; generics need bioequivalence data against the Korean reference product; and drugs that are not new but differ from approved ones — new salts, dosage forms or indications — fall in the middle category of data-required drugs (자료제출의약품, jaryo jechul uiyakpum).

Approvals are valid for five years under Article 31-5 of the Pharmaceutical Affairs Act and must be renewed before expiry; renewal can be refused for safety reasons or if the product was not supplied during the period. New drugs undergo re-examination (재심사, jaesimsa) under Article 32 four to six years after approval, depending on the product. During that period generic applicants cannot rely on the originator’s data, which makes re-examination Korea’s practical form of data exclusivity.

Sources: MFDS GIFT programme; Dailypharm, 2026.

The headline numbers have moved fast. MFDS reports that average review time for new drugs fell from about 420 days to about 295, after it switched from sequential to parallel review of quality, non-clinical and clinical data, enlarged its review staff and introduced at least two face-to-face meetings before submission. A 240-day framework for new drugs was introduced in 2026. The statutory clock, however, stops whenever MFDS asks for more data, and companies routinely spend months answering — usually on GMP evidence, multinational clinical data and quality verification. The fastest GIFT product approved in 2026 took 305 days from designation; the slowest took 801.

Korea also runs a patent linkage system. The originator lists its patents on MFDS’s patent list (의약품 특허목록, uiyakpum teukheo mongnok); a generic applicant challenging them must notify the patent holder, who can obtain a stay on the generic’s sales while the dispute is decided, and the first successful challenger can earn a period of generic exclusivity. Foreign originators that fail to list their patents lose the stay.

Price and reimbursement

Almost every Korean resident is insured by the National Health Insurance Service (국민건강보험공단, gungmin geongang boheom gongdan), so for prescription drugs the price question is a reimbursement question. Korea uses a positive list: a drug is reimbursed only once listed. The applicant — again, the Korean licence holder — applies to the Health Insurance Review and Assessment Service (건강보험심사평가원, geongang boheom simsa pyeongga-won) (HIRA), which assesses clinical usefulness and, for new drugs claiming an advantage, cost-effectiveness. New drugs then negotiate a price with the NHIS before the health ministry lists them. Products that are not reimbursed can still be sold at a price the company sets, but in a market where doctors and patients default to the reimbursed list.

The government reformed pricing in March 2026. Generic prices, set as a share of the originator’s pre-generic price, fall from 53.55% to a new base of 45%, phased in for listed products from the second half of 2026; companies designated as innovative or as supply-stability leaders get higher rates. An expedited pathway for qualifying innovative and rare-disease drugs aims to complete HIRA review and NHIS negotiation within 100 days, with reference to prices in selected foreign countries, and flexible pricing contracts allow the listed price and the effective price to differ. The reform also tightens re-evaluation of older listed drugs.

Customs, batch testing and serial numbers

Every import of a finished drug passes a pharmaceutical check before Korean customs releases it: the importer files a standard customs pre-report (표준통관예정보고, pyojun tonggwan yejeong bogo) with the Korea Pharmaceutical Traders Association, which confirms that the importer and the product are licensed for what is being shipped. Customs then applies duty and 10% import VAT. Korea’s basic tariff on finished medicaments in heading 3004 is 8%, but under Korea’s free trade agreements with the EU, the United States, the United Kingdom, Australia, Canada and others most medicines of those origins enter duty-free with proof of origin; see customs duties in Korea.

Imported batches must then be tested for quality before release, in the importer’s own laboratory or by a testing institution it contracts, with limited exemptions. For prescription drugs, every shipment from the importer must carry a serial number and be reported to HIRA’s drug information centre — a requirement that applied to manufacturers and importers from July 2016 and has been enforced with penalties since 2019. Narcotics and psychotropics need separate import approval under the Narcotics Control Act.

Distribution, promotion and compliance

An importer may sell to wholesalers and, for its own products, directly to hospitals and pharmacies, but most foreign-owned importers use a licensed wholesaler (의약품 도매상, uiyakpum domaesang) — a separate permit under Article 45 of the Pharmaceutical Affairs Act — that meets Korean Good Supply Practice for storage, cold chain and recalls. Korean hospital tenders and the wholesale margin structure make the choice of wholesaler a commercial decision as much as a regulatory one.

Promotion is tightly drawn. Prescription drugs may not be advertised to the public under Article 68; communication goes to healthcare professionals. Giving doctors or pharmacists money or other economic benefits (경제적 이익, gyeongjejeok ieok) to promote prescribing is banned by Article 47, and both giver and recipient can be punished. The permitted exceptions — samples, academic conference support, product presentations, clinical trials — must be recorded in an annual expenditure report (지출보고서, jichul bogoseo) under Article 47-2, Korea’s Sunshine Act, with supporting documents kept for five years. Importers must also run pharmacovigilance, reporting adverse reactions to MFDS and the Korea Institute of Drug Safety and Risk Management on the deadlines in MFDS rules, and appoint a person responsible for safety information.

Border cases: quasi-drugs, supplements, devices

• Quasi-drugs (의약외품) — masks, disinfectants, oral care, some topical and hygiene products — are regulated by the Pharmaceutical Affairs Act with lighter product notification. The same pharmacist can manage drug and quasi-drug imports at one site.
• Health functional foods (건강기능식품) fall under the Health Functional Foods Act and may make only MFDS-recognised function claims. A supplement sold as a medicine abroad may be a food in Korea, and the reverse.
• Medical devices (의료기기), including diagnostic kits and medical software, fall under the Medical Devices Act with their own import licence, classes I–IV and device GMP.
• Combination products are classified by their primary mode of action; ask MFDS for a classification opinion before you file.
• Orphan and essential drugs not approved in Korea can reach patients through the Korea Orphan & Essential Drug Center, which imports them on prescription.

Setting up the Korean importer

For a foreign group that wants its own licence holder, the order matters. First the Korean company — usually a Jusik Hoesa (주식회사, jusik hoesa) registered as a foreign investment under the Foreign Investment Promotion Act. Then premises that meet the facility rules, the pharmacist import manager, the import business report, and only then product filings in the company’s own name. A subsidiary that takes over products from a distributor should agree the transfer sequence with MFDS and the distributor so that supply does not stop. Our guides to importing through your own Korean company, hiring in Korea and trademark registration cover the surrounding steps; brand names should be cleared and filed before the product name is fixed in the approval.

A worked example

A Danish maker of specialty dermatology drugs sells two products in Korea through a distributor that holds the approvals. It wants a third, new product launched under its own control. It forms a Seoul Jusik Hoesa with KRW 300 million of capital, leases an office with a small compliant storage area, hires a Korean pharmacist as import manager, and files the import business report. The Danish and Polish manufacturing sites are registered; MFDS reviews their EU GMP certificates and asks for one supplementary batch-record package.

The new drug is filed in the subsidiary’s name and approved after one clock-stop. HIRA accepts a cost-effectiveness claim, and the NHIS negotiation closes on a listed price with a confidential refund. A KGSP wholesaler handles storage and delivery to hospitals; serial numbers flow to HIRA from the first shipment. The two older products move from the distributor under the transfer clause it signed years earlier — the only reason the move takes months rather than years.

Mistakes we see

1. Letting a distributor file in its own name without a written transfer obligation.
2. No pharmacist when the import business report is filed — or one who also works elsewhere.
3. Unregistered or outdated foreign site registrations after a manufacturing change.
4. A dossier built for another region without Korean reference products, Korean labelling or ethnic-factor analysis.
5. Missing patent listings, which forfeit the stay against generics.
6. Promotion habits imported from elsewhere — public advertising of prescription drugs, or hospitality that is not in the expenditure report.
7. Approvals left to lapse at the five-year renewal because the product was not supplied.

Korean terms you will meet

Questions readers ask

About the author

Alexander Baranov

Founder of the BCA Group · cross-border corporate and tax adviser since 2008

Alexander advises foreign founders and groups on company formation, tax structuring and corporate law in more than 40 jurisdictions across Europe, the Gulf, Asia and Latin America. He is the author of nine books on international business and tax and writes regularly for professional finance and tax journals. He works in English, German, Spanish and Russian.

This guide is based on the Korean statutes cited in the text and on our own filings. It is reviewed when the law or official rates change.

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