South Korea · Ministry of Food and Drug Safety · New drugs
Review target
70 working days
regulation
Legal time limit
-
Not published
Steps
5
6 requirements
Application fee
-
Drugs that are not new drugs but still need a safety and efficacy review use this route. Examples are new combinations, new routes of administration, new indications and new salts. The MFDS reviews the selected data that apply to the change. A known active substance with a change that needs new safety or efficacy data, such as a new route, strength, indication or combination.
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.
1. Submit the item permit application; 2. Pre-review of completeness; 3. Review of the submitted data (70 days); 4. Answer requests for more data; 5. 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 31 and 31-6; Regulation on Approval, Notification and Review of Pharmaceuticals, Article 2(8) and (9)
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
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. | 70 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: New drug item permit, 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.