1 Introduction

MHLW (the parent agency of PMDA) made an announcement regarding changes to the PSR report, as well as the ReSD report, on November 28, 2017. As per the updated guidance, MAHs can submit the PSR/ReSD reports to PMDA in the updated format starting on the date of publication of the new guidance. The updated guidance makes it mandatory for MAHs to submit dossiers in the updated format starting in October 2019. As per the updated guidance, there are several updates to the ReSD report, which in turn impact several forms in the PSR report for which regulatory output overlaps with the ReSD reporting format.

ReSD Guidance Notification:

(PSEHB/ELD Notification No.1128-2 dated November 28, 2017)

PSR Guidance Notification:

(PSEHB/ELD Notification No.1128-5, PSEHB/SD Notification No.1128-4 dated November 28, 2017)

As a result of the updated guidance, the following areas of impact on Japan periodic reports have been identified, for which Oracle Argus Safety functionality for Japan periodic reports has been enhanced.

• Changes to ReSD Forms:
  • Updated ReSD Forms
    • ReSD Form 4 updated to ReSD Form 10 (Table)
    • ReSD Form 5 updated to ReSD Form 11 (Listing)
  • New ReSD Forms
    • Form 9 (Unlisted Events table)
    • Form 13 (Status of Overseas Measures Report)
    • Form 14 (Status of Study Report)
• Due to changes in ReSD, the following PSR Forms have been updated:
  • PSR Form 3 (Table)
  • PSR Form 4 (Listing)

This document lists recommendations on how to use the enhanced Japan periodic reports.