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Published on 22/12/2025

MFDS Submissions and Korean GCP Alignment SOP

Department	Clinical Research
SOP No.	CS/MFDS-CTA/195/2025
Supersedes	N.A.
Page No.	1 of 26
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to define processes for submitting clinical trial applications and related documentation to the Ministry of Food and Drug Safety (MFDS) in South Korea, while ensuring full alignment with Korean Good Clinical Practice (KGCP). It ensures that sponsor and investigator obligations are fulfilled in compliance with local regulations and international GCP standards.

Scope

This SOP applies to all clinical trials conducted in South Korea that require MFDS authorization. It covers clinical trial applications (CTA), amendments, safety reporting, DSURs, ICSRs, and archiving. It applies to sponsors, CROs, investigators, regulatory affairs teams, and quality assurance staff engaged in clinical research.

Responsibilities

• Sponsor: Prepares and submits CTA dossier, oversees communications with MFDS, and ensures compliance with KGCP.
• Regulatory Affairs (RA): Compiles required documents, submits applications, and maintains submission logs.
• Principal Investigator (PI): Provides site-level documentation and ensures compliance with approved protocols.
• CRO: Assists with dossier preparation, submissions, and communications with MFDS, as delegated.
• Quality Assurance (QA): Reviews submission packages and ensures inspection readiness.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for timely and complete MFDS submissions. The PI is accountable for site-level compliance with KGCP and MFDS requirements.

Procedure

1. Preparation of CTA Dossier

1. Compile dossier including protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF), Investigator CVs, GMP certificates, and relevant preclinical/CMC data.
2. Ensure translations into Korean where required.
3. Complete Submission Checklist (Annexure-1).

2. Submission to MFDS

1. Submit application electronically to MFDS via official portal.
2. Maintain record of submission reference number in Submission Log (Annexure-2).

3. Ethics Committee (EC) Coordination

1. Submit documents simultaneously to Institutional Review Boards (IRBs) for approval.
2. Ensure IRB approval is aligned with MFDS requirements before trial initiation.

4. Safety Reporting

1. Report SAEs and SUSARs in accordance with MFDS timelines.
2. Submit ICSRs electronically to MFDS pharmacovigilance systems.
3. Prepare annual DSUR and submit within 60 days of data lock point.

5. Amendments

1. Prepare substantial amendment packages including revised protocol, IB, or ICF.
2. Submit to MFDS and IRB for approval prior to implementation.

6. Documentation and Archiving

1. Maintain TMF and ISF per KGCP requirements.
2. Archive documents for a minimum of 10 years post-trial completion.

Abbreviations

• MFDS: Ministry of Food and Drug Safety
• KGCP: Korean Good Clinical Practice
• CTA: Clinical Trial Application
• PI: Principal Investigator
• RA: Regulatory Affairs
• CRO: Contract Research Organization
• QA: Quality Assurance
• IB: Investigator’s Brochure
• ICF: Informed Consent Form
• DSUR: Development Safety Update Report
• ICSR: Individual Case Safety Report
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Submission Checklist (Annexure-1)
2. Submission Log (Annexure-2)
3. Safety Reporting Log (Annexure-3)

References

• MFDS — Ministry of Food and Drug Safety
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trials Guidelines

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Submission Checklist

Document	Included (Y/N)	Reviewer	Date
Protocol	Y	Rajesh Kumar	05/08/2025
Investigator’s Brochure	Y	Sunita Reddy	06/08/2025

Annexure-2: Submission Log

Date	Protocol No.	Document	Submitted To	Status
12/08/2025	KR-2025-01	CTA Dossier	MFDS	Under Review

Annexure-3: Safety Reporting Log

Date	Case ID	Event	Submitted To	Status
15/08/2025	SAE-101	Severe Hepatic Injury	MFDS	Submitted

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for MFDS submissions and Korean GCP alignment.	New SOP created for regulatory compliance in South Korea.	Head of Clinical Research

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