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Local PV Reporting and Audits SOP

Purpose

This SOP establishes standardized procedures for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with MFDS safety reporting timelines, Korean GCP (KGCP), and international guidelines, thereby protecting patient safety and ensuring inspection readiness.

Scope

This SOP applies to all clinical trials conducted in South Korea under sponsor or investigator responsibility. It includes safety case collection, SAE/SUSAR reporting, ICSR submission, DSUR preparation, PV audits, and archiving of safety documents. It applies to sponsors, CROs, investigators, PV officers, QA, and regulatory affairs staff.

Responsibilities

• Sponsor PV Team: Oversees safety case management, prepares ICSR and DSUR reports, and ensures submission to MFDS within timelines.
• Principal Investigator (PI): Identifies, documents, and reports SAEs within 24 hours to sponsor.
• CRC: Supports PI in documentation and reporting of adverse events.
• Regulatory Affairs (RA): Submits safety reports and ensures acknowledgment from MFDS.
• Quality Assurance (QA): Conducts audits on PV processes, documentation, and timelines.
• CRO (if delegated): Provides PV reporting support and ensures alignment with MFDS requirements.

Accountability

The sponsor’s Qualified Person for Pharmacovigilance (QPPV) or designated Korean safety officer is accountable for PV compliance. The PI is accountable for ensuring site-level safety reporting.

Procedure

1. SAE and SUSAR Reporting

1. Document SAEs in SAE forms and notify sponsor within 24 hours.
2. Sponsor PV team evaluates seriousness, causality, and expectedness.
3. Fatal or life-threatening SUSARs: submit within 7 days; all others within 15 days.

2. ICSR Submissions

1. Prepare ICSRs in MFDS-compliant electronic format.
2. Submit through MFDS PV reporting systems.
3. Log cases in ICSR Log (Annexure-1).

3. DSUR Preparation and Submission

1. Compile DSUR annually with cumulative global and local safety data.
2. Submit DSUR to MFDS within 60 days of data lock point.

4. PV Audits

1. QA team performs annual audits of PV systems and safety databases.
2. Audit findings are documented with CAPA in Audit Log (Annexure-2).

5. Documentation and Archiving

1. Maintain SAE forms, SUSAR reports, ICSR logs, DSURs, and audit reports in TMF/ISF.
2. Archive PV records for a minimum of 10 years as per MFDS requirements.

Abbreviations

• MFDS: Ministry of Food and Drug Safety
• KGCP: Korean Good Clinical Practice
• PV: Pharmacovigilance
• QPPV: Qualified Person for Pharmacovigilance
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• ICSR: Individual Case Safety Report
• DSUR: Development Safety Update Report
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• ISF: Investigator Site File
• TMF: Trial Master File

Documents

1. ICSR Log (Annexure-1)
2. Audit Log (Annexure-2)
3. DSUR Submission Log (Annexure-3)

References

• MFDS — Ministry of Food and Drug Safety
• ICH E6(R2) Good Clinical Practice
• ICH E2F: Development Safety Update Report

Version: 1.0

Approval

Annexures

Annexure-1: ICSR Log

Annexure-2: Audit Log

Annexure-3: DSUR Submission Log

Revision History

For more SOPs visit: Pharma SOP.

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MFDS Submissions and Korean GCP Alignment SOP

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

Annexures

Annexure-1: Submission Checklist

Annexure-2: Submission Log

Annexure-3: Safety Reporting Log

Revision History

For more SOPs visit: Pharma SOP.