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 of 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 published on the JPMA website and are now available in English.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Regulatory Affairs Committee
Basic Research Department 2022 Issue Team 7