South Korea · Ministry of Food and Drug Safety · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
2 requirements
Application fee
-
Developers of cell and gene therapies can ask the MFDS for fast-track designation. The agency decides within 60 days. Designated products can get customized review of data filed in stages during development, priority review of the permit application, and a conditional permit based on early evidence. Advanced biologics for serious diseases such as cancer with no alternative, for rare diseases, or for pandemic or bioterror infections.
1. Apply for fast-track designation; 2. Designation decision (60 days); 3. Customized staged review; 4. Priority review of the permit application; 5. Full or conditional permit.
Outcome: Fast-track designation, then a full or conditional item permit.
Legal basis: Act on Advanced Regenerative Medicine and Advanced Biological Products, Articles 36 to 38; Regulation on Safety and Support for Advanced Biological Products, Articles 36 to 38
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 60 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: Orphan drug designation, Item permit for advanced biological products (cell and gene therapy). 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.