Drug Evaluation Committee Hints for the Introduction and Use of Quality Management Systems in PV
Pharmacovigilance Subcommittee
April 2022
With the globalization of the pharmaceutical market, there is an increasing need for pharmaceutical companies to conduct pharmacovigilance activities in Japan with overseas laws and regulations in mind. Especially for companies that are expanding globally or have business agreements with such companies, compliance with EU regulations (EU-GVP), which are presented as a legal basis for inspections by overseas regulatory authorities or PV audits by overseas partner companies, is unavoidable. QMS (Quality Management System) is stipulated in the EU-GVP Module I.
Therefore, KT7 believes that incorporating the concept of QMS will enable us to study more effective quality improvement processes, and we have decided to publish a white book containing information that will provide hints for practical application of QMS and PV systems required by the EU-GVP, while giving specific examples of QMS.
It would be our greatest pleasure if this white paper can be used as a reference for companies that intend to introduce or utilize a QMS, to improve the quality of their PV operations, and to foster a culture of quality.
Please note that the white book "Study of Quality Management System in Pharmacovigilance: Pharmacovigilance Subcommittee FY 2018-2019 Task Force 1 Ver 1.0 March 2020," which is the deliverable of the former TF1 cited in the said deliverable, Please note that it is available only to the PV Subcommittee.
Pharmaceutical Evaluation Committee
PV Subcommittee Continuing Issues Response Team 7 (KT7)
Tips for Implementing and Utilizing a Quality Management System in PV (2.2MB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables