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South Korea’s IND application process is regulated by the Ministry of Food and Drug Safety (MFDS), offering a globally aligned and streamlined pathway for initiating clinical trials. With a 30-day review window and a strong focus on safety and compliance, the South Korea IND application process helps sponsors fast-track drug development while meeting Regulatory expectations.
South Korea IND Application Process: Key Phases and Requirements
Introduced in 2002, the South Korea IND application framework supports the safe and efficient development of innovative therapies. Overseen by the MFDS, it aligns with global best practices and ensures clinical trials in South Korea meet international quality and safety standards.
1. Pre-Submission Preparation
Before initiating the application, sponsors must classify the drug—new chemical entity (NCE), biologic, biosimilar, or reformulated product. All submissions follow the ICH Common Technical Document (CTD) format.
Key components of the dossier include:
- Preclinical safety and pharmacology data
- Clinical trial protocol
- Chemistry, Manufacturing and Control (CMC) documentation
- GMP certificates
- Investigator Brochures and Informed Consent Forms (translated into Korean)
Foreign sponsors are required to appoint a local representative to act as the primary liaison with MFDS. A pre-submission meeting is encouraged to clarify product classification and documentation expectations.
2. IND Application Submission to MFDS
Applications are submitted via the MFDS’s Drug Approval Information System (NeDrug e-Drug Service). In parallel, the clinical trial must be reviewed by an Institutional Review Board (IRB) in South Korea.
Submission documents include:
- Administrative and regulatory forms
- CMC and GMP data
- Preclinical and clinical information
- Risk Management Plan (if applicable)
- Trial site and investigator credentials
Approval from both MFDS and IRB is mandatory before trial initiation.
3. MFDS IND Review Timeline and Evaluation Scope
The MFDS IND approval review is typically completed within 30 working days. However, depending on the dossier complexity, the process may take up to 2–3 months.
MFDS review includes:
- Administrative Review – Compliance check
- Scientific Review – Assessment of safety, efficacy, and protocol
- CMC & GMP Review – Verification of product quality and manufacturing standards
If deficiencies are identified, MFDS may place the application on clinical hold and request clarifications or additional data.
4. Trial Initiation and Post-Approval Compliance
Upon approval, sponsors may begin the clinical trial under Korean Good Clinical Practice (KGCP) guidelines. Continuous compliance is critical throughout the trial lifecycle.
Post-approval obligations:
- Submission of Serious Adverse Event (SAE) reports
- Annual safety updates
- Protocol amendments (if any)
- Pharmacovigilance reports
5. Transitioning to Marketing Authorization
Following successful trial completion, sponsors may file a New Drug Application (NDA) or Biologics License Application (BLA). The South Korea drug development process then moves into the final evaluation phase, where MFDS reviews product safety, efficacy, and quality for market entry.
IND Approval Workflow Summary
| Phase | Key Activity |
| Pre-submission | Dossier preparation, pre-meeting with MFDS |
| Submission | Through MFDS portal(NeDrug); IRB review in parallel |
| MFDS Review | Within 30 working days (may extend to 2–3 months) |
| Approval | IND granted or clinical hold issued |
| Trial Initiation | Upon MFDS and IRB approval |
| Post-approval Reporting | Ongoing safety updates and amendments, pharmacovigilance reports |
| Transition to NDA/BLA | After trial completion for marketing approval |
Conclusion: Navigating the South Korea IND Application Process
The South Korea IND application process offers sponsors a globally harmonized and efficient route for clinical trial initiation. With defined timelines, robust regulatory oversight, and a structured review process, South Korea remains a preferred destination for early-stage drug development.
Need help navigating MFDS IND submission requirements or understanding Korean clinical trial regulations? Freyr offers end-to-end support for clinical trial approval in South Korea, ensuring speed, accuracy, and compliance.
