SOP for Safety Reporting to PMDA

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Published on 22/12/2025

Safety Reporting to PMDA SOP

Department	Clinical Research
SOP No.	CS/PMDA-SAF/171/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Table of Contents

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

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

2. SUSAR Reporting

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

3. Narrative Preparation

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

4. DSUR and Periodic Safety Reporting

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

5. Documentation and Archiving

Maintain SAE Case Files, SUSAR Submission Logs, and Safety Reporting Logs.
Archive safety reports for at least 15 years or as per PMDA requirements.
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

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

References

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: SAE Reporting Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
JPN-001	Severe Rash	15/08/2025	Recovered	Related	16/08/2025

Annexure-2: SUSAR Submission Log

Case ID	Subject ID	Event	Report Type	Date Submitted	Acknowledgment
SUS-2201	JPN-002	Anaphylaxis	7-day Expedited	17/08/2025	Received

Annexure-3: Safety Reporting Log

Date	Submission Type	Reference	Status	Submitted By
25/08/2025	DSUR	PMDA-DSUR-2025	Submitted	Sunita Reddy

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for safety reporting to PMDA.	New SOP created for compliance with J-GCP and PMDA requirements.	Head of Clinical Research

For more SOPs visit: Pharma SOP.