Drug Evaluation Committee KT5: Investigation Report Form for Pharmacovigilance Regulations
Pharmacovigilance Subcommittee
August 2025
Japan Pharmaceutical Manufacturers Association
Dear members of Pharmacovigilance Subcommittee
We are pleased to inform you that we have published the following information on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
White Book: Pharmacovigilance Regulatory Investigation Report Form (Example) (Japanese and English versions)
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Continuing Issues Response Team 5 (KT5)
Deliverables
Pharmacovigilance Regulatory Investigation Report Form
PV Navi
Category: 8. Others Deliverables (QMS, GVP recommissioning, etc.)
Background
The pharmaceutical industry is expanding globally and collaborating with overseas companies, and pharmaceutical companies are required to appropriately comply with pharmacovigilance (PV) regulations not only in Japan but also in other countries involved. Even if a company is only selling pharmaceuticals or conducting clinical trials in Japan, if it has overseas partners, it needs to establish a business system that takes into account the regulations of each country. Therefore, it is important for pharmaceutical companies that operate internationally to accurately grasp and understand the PV regulations of the countries concerned and reflect them in internal procedures and alliance agreements as necessary. In order to accurately respond to such regulations in each country, it is essential to have a so-called "Pharmacovigilance Regulatory Intelligence (PVRI)" system in place, a system that constantly collects and evaluates the latest information, assesses its impact, and can respond quickly. In light of this situation, we have prepared a "Local Regulatory Survey Report Form (Example)" (Japanese/English checklist) as an aid to building a PVRI system to respond to the frequent regulatory changes that have taken place in recent years. We hope that this document will be useful in efficiently collecting information on overseas PV regulations and standardizing your operations.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables