South Korea · Ministry of Food and Drug Safety · Biologics
Review target
115 working days
regulation
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
₩8,031,000
Notice 2026-31
Biological products, recombinant products, cell-culture products and vaccines get an item permit from the MFDS under the biologics regulation. The review covers quality, nonclinical and clinical data and biologics GMP. Vaccines and other biologics also need national lot release for each lot before sale. Vaccines, plasma-derived products, antitoxins, recombinant proteins, antibodies and other biologics. Cell and gene therapies use the advanced biologics route.
The official review target is 115 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The item permit, new biologic that is not a new drug or biosimilar (electronic filing) is ₩8,031,000 for Notice 2026-31.
1. Submit the item permit application; 2. Review of quality, safety and efficacy (115 days); 3. Answer requests for more data; 4. Permit decision; 5. National lot release for each lot.
Outcome: An item permit valid for 5 years and renewable. Each lot then needs national lot release. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act, Articles 31, 42 and 53; Regulation on Approval and Review of Biological Products
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 115 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Official processing periods, not actual review times. Periods over 5 days count working days (Saturdays and public holidays are not counted). Time the applicant spends answering requests is outside the period. | 115 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Item permit, new biologic that is not a new drug or biosimilar (electronic filing)Application · Notice 2026-31 · A 10 percent surcharge applies when the applicant asks for face-to-face review. | ₩8,031,000 |
| Item permit, biologic that is a new drug (electronic filing)Application · From 2025-01-01 · Small and medium firms pay 50 percent. | ₩410,000,000reduced ₩205,000,000 |
Other routes in South Korea: Biosimilar item permit, National lot release for vaccines and other biologics, Priority review designation (GIFT), Conditional item permit, Orphan drug designation. See all routes on the South Korea page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.