South Korea · Ministry of Food and Drug Safety · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
A developer can ask the MFDS to designate a medicine in development for priority review. The agency decides within 30 days. Designated products are reviewed ahead of others, within 90 days unless there are special circumstances. The agency runs this program under the name GIFT and also offers rolling review and close contact with reviewers. Medicines for serious diseases such as life-threatening cancer, or for rare diseases, where there is no alternative or the product is clearly better; and new drugs from innovative drug companies at the health ministry's request.
The official review target is 90 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Apply for designation; 2. Designation decision (30 days); 3. Rolling submission of data; 4. Priority review of the permit application (90 days); 5. Permit decision.
Outcome: A priority review designation; the permit application is then reviewed first.
Legal basis: Pharmaceutical Affairs Act, Articles 35-4 and 35-5; Regulation on Safety of Pharmaceuticals, Article 40-2
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 120 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. | 90 working days |
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, Conditional item permit, Orphan drug designation, Item permit for advanced biological products (cell and gene therapy), 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.