Drug Evaluation Committee Checklist for Voluntary Inspection of Non-clinical Studies_ver.1
Basic Research Subcommittee
March 2023
The Checklist for Non-clinical Studies, which has been posted on the PMDA website (https://www.pmda.go.jp/review-services/inspections/gcp/0002.html), has been changed back to its original purpose of being used as a reference for self-inspection by the applicant. The checklist is now available on the JPMA website and can be used by applicants.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Regulatory Affairs Committee
New Drug Regular Opinion Exchange Meeting Non-clinical Sub-Working Group
Basic Research Department Task Force 7 for FY2022