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 revised to be prepared by the applicant, returning 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 as a reference for self-inspection by applicants.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation, Pharmaceutical Affairs Committee
Non-clinical Sub-Working Group of the Regular Opinion Exchange Meeting on New Drugs
Basic Research Department Task Force 7 for FY2022
Deliverables of the Drug Evaluation Committee Return to list of all deliverables