Drug Evaluation Committee Toward Realization of Fair Clinical Trial Costs in Japan Clinical Trial Cost Calculation Process Based on Fair Market Value (May 2019)
Clinical Evaluation Subcommittee
May 2019
The Clinical Evaluation Subcommittee TF-4 in FY 2018 prepared an educational slide on the Fair Market Value (hereinafter referred to as "FMV") based clinical trial cost calculation process (hereinafter referred to as "this slide") with the aim of introducing and spreading the "appropriate clinical trial cost calculation process" in Japan. The slide summarizes the current status of clinical trial costs and the issues that need to be addressed in order to calculate appropriate clinical trial costs, and proposes the introduction of a clinical trial cost calculation process based on FMV, which is widely used in other countries, as a solution for ensuring appropriate clinical trial costs.
We hope that both sponsors and medical institutions will understand the concept of FMV and use these slides when considering the use of the FMV-based clinical trial costing process and when educating all parties concerned.
We hope that these slides will contribute to the optimization of Japan's clinical trial costs and the maintenance of its international competitiveness.
Joint Statement by Four Organizations "On Calculating Task-Based Clinical Trial Costs Based on FMV" (January 2026)
Based on the recommendations of the "Study Group on Regulation of Pharmaceutical Affairs to Enhance Drug Discovery Capability and Ensure Stable Supply," and the "Clinical Research Committee of the Health Sciences Council," sound discussions were held to introduce task-based cost calculation based on the FMV concept for costs incurred by medical institutions conducting clinical trials (costs for medical institutions conducting clinical trials and SMO costs). In order to promote the creation of a sound consultative environment for the introduction of task-based costing based on the concept of FMV, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), the Clinical Subcommittee of the Technical Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Clinical Subcommittee of the Technical Committee of the European Federation of Pharmaceutical Industries and Associations (EFPIA Japan) and the R&D Head Club have jointly issued the following statement.
We would like to ask our member companies to disseminate this statement to all parties concerned and to cooperate in promoting the introduction of task-based costing based on the concept of FMV.