Drug Evaluation Committee English version of Checklist and Q&A for Voluntary Inspection of Non-clinical Studies_ver.1
Basic Research Subcommittee
July 2025
The Non-clinical Sub-Working Group of the Regular Opinion Exchange Meeting on New Drugs has been discussing the checklist and Q&A for self-inspection related to non-clinical studies to be prepared by the applicant side with the industry organizations (PhRMA, efpia, JPMA) and PMDA. The results of these discussions have been made publicly available on the JPMA's website, and now an English version has been prepared and will be made public as well.
JPMA, Committee on Drug Evaluation, Committee on Regulatory Affairs
Basic Research Department 2022 Issue Team 7
Deliverables of the Drug Evaluation Committee Return to list of all deliverables