South Korea · Ministry of Food and Drug Safety · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
3
3 requirements
Application fee
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The MFDS designates orphan drugs for rare diseases, or for rare uses where there is no alternative or the product is clearly safer or more effective. Rare use means 20,000 or fewer patients in Korea. Products still in development can get a development-stage designation. Orphan drugs get 10 years of clinical data protection after approval. Drugs for rare diseases under the Rare Disease Management Act, or for conditions with 20,000 or fewer patients in Korea.
1. Apply for designation; 2. Assessment by the MFDS; 3. Designation and publication.
Outcome: Orphan designation, published on the MFDS website. It also opens the conditional permit and priority review routes.
Legal basis: Pharmaceutical Affairs Act, Articles 2(18) and 31-6; Regulation on Orphan Drug Designation
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), Conditional item permit, Item permit for advanced biological products (cell and gene therapy), Fast-track designation for advanced biological products, Drug-device combination products. See all routes on the South Korea page or explore them in the .
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.