Drug Evaluation Committee QMS in PV
January 2026
We believe that implementing a Quality Management System (QMS) and maintaining a continuous quality cycle at each pharmaceutical company—by proactively identifying issues and independently devising and implementing solutions—contributes to improving the quality of pharmacovigilance (PV) operations.
At KT-7, we delivered a lecture titled “QMS in Pharmacovigilance” on March 5, 2025, as part of the RS Foundation Expert Training Program “Fiscal Year 2024: Building and Implementing an International-Standard PV System Based on Global PV Regulations,” covering the overview and importance of QMS.
To help a wider audience deepen their understanding of QMS, we have prepared this explanation document on QMS in PV based on the materials from that lecture.
We hope this document will help promote understanding of QMS within pharmaceutical companies and contribute to further improving the quality of PV operations.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee
, Pharmacovigilance Subcommittee, Ongoing Issues Response Team 7 (KT-7)