South Korea · Ministry of Food and Drug Safety · Cell and gene therapy
Review target
70 working days
regulation
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
₩205,000,000
From 2026-06-30
Cell therapies, gene therapies, tissue-engineered products and advanced combined products get an item permit from the MFDS under the Advanced Regenerative Bio Act. The applicant files safety and efficacy data, GMP and test method data, GMP evaluation data and a risk management plan. Some products need long-term follow-up of treated patients. Cell therapy, gene therapy, tissue-engineered products, and combinations of these with a medical device where the drug part is the main function.
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 advanced biologic that is a new drug: safety and efficacy review part of the permit fee (non-sme) is ₩205,000,000 for From 2026-06-30. A reduced fee of ₩102,500,000 applies in some cases (Small and medium firms pay half. Separate parts apply for GMP and test method review and for GMP evaluation).
1. Submit the item permit application; 2. Review of safety, efficacy, GMP and test methods (70 days); 3. Answer requests for more data; 4. Permit decision.
Outcome: An item permit. The holder is treated as a permit holder under the Pharmaceutical Affairs Act.
Legal basis: Act on Advanced Regenerative Medicine and Advanced Biological Products, Articles 2, 23, 27 and 30; Regulation on Safety and Support for Advanced Biological Products
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 |
|---|---|
| Advanced biologic that is a new drug: safety and efficacy review part of the permit fee (non-SME)Application · From 2026-06-30 · Small and medium firms pay half. Separate parts apply for GMP and test method review and for GMP evaluation. | ₩205,000,000reduced ₩102,500,000 |
Other routes in South Korea: Priority review designation (GIFT), Orphan drug designation, Fast-track designation for advanced biological products, 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.