Drug Evaluation Committee Checklist for Self-inspection for Quality Assurance Tests_ver.1
Basic Research Subcommittee
March 2026
As a result of discussions between the JPMA, PhRMA, and EFPIA and the PMDA during the activities of the Non-clinical Sub-Working Group of the Regular Opinion Exchange Meeting on New Drugs, the industry associations (JPMA, PhRMA, and EFPIA) decided to abolish the Written Compliance Survey Checklist for Quality Studies that had been posted on the PMDA website as well as the Non-clinical Studies, and to newly establish the "Checklist for Self-Inspection of Quality Studies. As a result, the PMDA has decided to discontinue the Written Compliance Checklist for Quality Studies, which had been posted on the PMDA website, as well as for non-clinical studies.
This checklist for self-inspection is a summary of points to be considered when confirming the reliability of the quality tests used in the application materials for approval in order to fulfill the applicant's responsibility. Please use this checklist as a material for making a comprehensive judgment as to whether or not the quality tests are reliable enough to be used as application materials. We will continue to revise the checklist as necessary.