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Safety Reporting to PMDA SOP

Purpose

This SOP describes the requirements and processes for safety reporting to the Pharmaceuticals and Medical Devices Agency (PMDA). It defines obligations for sponsors, investigators, and pharmacovigilance teams for expedited reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and other reportable events in compliance with Japanese Good Clinical Practice (J-GCP) and international pharmacovigilance standards.

Scope

This SOP applies to all clinical trials conducted in Japan or under PMDA oversight. It includes expedited reporting of SAEs and SUSARs, periodic reporting obligations, narrative requirements, case documentation, and submission of Individual Case Safety Reports (ICSRs). It applies to sponsors, CROs, investigators, and safety monitoring personnel.

Responsibilities

• Principal Investigator (PI): Reports SAEs to the sponsor within 24 hours and provides complete documentation.
• Clinical Research Coordinator (CRC): Collects supporting records and ensures SAE forms are complete and timely.
• Pharmacovigilance (PV) Team: Performs medical review, prepares SUSAR narratives, and ensures submissions to PMDA meet timelines.
• Regulatory Affairs (RA): Confirms all submissions are acknowledged by PMDA and filed in TMF.
• Quality Assurance (QA): Audits safety reporting workflows and verifies adherence to SOP and regulations.

Accountability

The Sponsor’s Qualified Safety Officer holds accountability for timely and accurate safety reporting to PMDA. The PI is accountable for ensuring completeness and accuracy of site-level safety data.

Procedure

1. SAE Reporting

1. PI must report all SAEs within 24 hours of awareness using the SAE Reporting Form.
2. SAEs should be documented in source records, with copies provided to sponsor PV team.
3. Investigator must assess seriousness, causality, and expectedness using the Investigator’s Brochure or Reference Safety Information (RSI).

2. SUSAR Reporting

1. Fatal or life-threatening SUSARs: submit within 7 calendar days to PMDA, followed by a full report within 8 additional days.
2. All other SUSARs: submit within 15 calendar days of sponsor awareness.
3. Reports must be submitted in E2B (R3) electronic format through the PMDA Gateway.

3. Narrative Preparation

1. Prepare detailed case narratives including subject demographics, medical history, event details, treatment, outcome, and causality assessment.
2. Translations into Japanese must be certified and archived in TMF.

4. DSUR and Periodic Safety Reporting

1. Prepare annual Development Safety Update Reports (DSURs) summarizing cumulative safety data, trends, and signal evaluation.
2. Submit DSURs to PMDA within 60 days of the data lock point.

5. Documentation and Archiving

1. Maintain SAE Case Files, SUSAR Submission Logs, and Safety Reporting Logs.
2. Archive safety reports for at least 15 years or as per PMDA requirements.
3. Ensure all records comply with ALCOA+ principles.

Abbreviations

• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSUR: Development Safety Update Report
• ICSR: Individual Case Safety Report
• PI: Principal Investigator
• PV: Pharmacovigilance
• RA: Regulatory Affairs
• QA: Quality Assurance
• RSI: Reference Safety Information
• TMF: Trial Master File

Documents

1. SAE Reporting Form (Annexure-1)
2. SUSAR Submission Log (Annexure-2)
3. Safety Reporting Log (Annexure-3)

References

• PMDA — Pharmaceuticals and Medical Devices Agency
• PMDA Drug Review and Safety Guidance
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report
• ICH E6(R2) Good Clinical Practice

Version: 1.0

Approval

Annexures

Annexure-1: SAE Reporting Form

Annexure-2: SUSAR Submission Log

Annexure-3: Safety Reporting Log

Revision History

For more SOPs visit: Pharma SOP.