South Korea · Ministry of Food and Drug Safety · Generics
Review target
55 working days
regulation
Legal time limit
-
Not published
Steps
4
8 requirements
Application fee
-
A generic has the same active ingredient, strength, route, indication and dosage as a new drug or another listed reference drug. The applicant files quality data, bioequivalence data and patent documents. Regional MFDS offices issue the permit. A prescription medicine that copies a reference drug already approved in Korea.
The official review target is 55 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Run a bioequivalence study; 2. Submit the item permit application; 3. Review of equivalence and quality data (55 days); 4. Permit decision by a regional office.
Outcome: An item permit issued by a regional office of the MFDS, valid for 5 years and renewable. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act, Articles 31(12), 31-6 and 50-2 to 50-10; Regulation on Safety of Pharmaceuticals, Article 4(1)(3)
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 55 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. | 55 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), 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.