South Korea · Ministry of Food and Drug Safety · New drugs
Review target
70 working days
regulation
Legal time limit
-
Not published
Steps
7
12 requirements
Application fee
₩410,000,000
From 2025-01-01
Companies that make or import a new drug apply to the MFDS for an item permit for each product. The agency reviews quality, nonclinical and clinical data, a risk management plan and GMP evidence. A medicine with a new active substance, or a combination product that contains one.
The official review target is 70 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The item permit or conditional permit, new drug (electronic filing) is ₩410,000,000 for From 2025-01-01. A reduced fee of ₩205,000,000 applies in some cases (Small and medium firms pay 50 percent. Applicants also pay travel costs for any foreign site inspection).
1. Submit the item permit application; 2. Pre-review of completeness; 3. Optional meetings with reviewers; 4. Review of safety, efficacy and quality (70 days); 5. Advice from the Central Pharmaceutical Affairs Council; 6. Answer requests for more data; 7. Permit decision.
Outcome: An item permit that is valid for 5 years and can be renewed. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act, Articles 2(8), 31, 31-6, 32-2 and 42; Regulation on Safety of Pharmaceuticals, Article 4
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 70 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
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. | 70 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Item permit or conditional permit, new drug (electronic filing)Application · From 2025-01-01 · Small and medium firms pay 50 percent. Applicants also pay travel costs for any foreign site inspection. | ₩410,000,000reduced ₩205,000,000 |
Other routes in South Korea: Item permit for data-submission drugs (including incrementally modified drugs), Generic drug item permit (bioequivalence), Item notification for monograph and standard-formula products, Priority review designation (GIFT), Conditional item permit, 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 (27 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet