South Korea · Ministry of Food and Drug Safety · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
5
3 requirements
Application fee
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For serious diseases and rare diseases, the MFDS can grant an item permit based on a clinical endpoint or a surrogate endpoint that reasonably predicts clinical benefit. The holder must submit confirmatory trial data within a set period. The agency first hears the Central Pharmaceutical Affairs Council. Medicines for life-threatening serious diseases such as cancer, and orphan drugs.
1. Apply for a conditional permit; 2. Review of early evidence; 3. Central Pharmaceutical Affairs Council opinion; 4. Conditional permit; 5. Annual progress reports and final trial report.
Outcome: A conditional permit. The agency must cancel it if the holder fails the conditions without good reason or got it by fraud.
Legal basis: Pharmaceutical Affairs Act, Articles 35, 35-2 and 35-3; Regulation on Safety of Pharmaceuticals, Articles 39-2 and 40
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: New drug item permit, Item permit for data-submission drugs (including incrementally modified drugs), Generic drug item permit (bioequivalence), Item notification for monograph and standard-formula products, Item permit for biological products and vaccines, Biosimilar item permit, National lot release for vaccines and other biologics, Priority review designation (GIFT), Orphan drug designation, Drug-device combination products. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.