Drug Evaluation Committee

Implementation Plan Overview

1. review of FY2025 and background of FY2026 implementation plan

Activities in FY2025

In FY2025, the Drug Evaluation Committee will focus on the following three basic approaches to its activities under its vision of "becoming a group that changes the world for the better through innovative technologies, methods, and policy recommendations": "Focus on policy recommendations," "Streamline activities," and "Strengthen collaboration with other committees and external stakeholders, The activities were developed in line with the 10 key activity themes.

In particular, FY2025 was an important year in which the domestic implementation of GCP Renovation including ICH E6 (R3) entered into a realistic phase and fundamental improvement of the clinical trial and clinical research environment in Japan was to be promoted. Therefore, we positioned 1) the establishment of a clinical trial/clinical research ecosystem and 2) regulatory compliance with the ICH-GL clinical research and the revision of the Pharmaceutical Affairs Act as the most important themes, and focused on building a framework for collaboration among industry, government, and academia and promoting activities to improve specific systems. With regard to the clinical trial/clinical research ecosystem, we have worked with PMDA, MHLW, academia, industry and other organizations, and through participation in the clinical trial ecosystem promotion project, etc., we have promoted world-class awareness of the need to correct inefficient clinical trial practices unique to Japan, introduce a single IRB, standardize clinical trial-related forms, and study the introduction of fair market value (FMV). Through participation in the Eco-System Promotion Project and other activities, we worked on specific improvement proposals with an awareness of global standards, such as correcting inefficient clinical trial practices unique to Japan, introducing a single IRB, standardizing clinical trial-related forms, and studying the introduction of Fair Market Value (FMV).
In addition, for the purpose of understanding and disseminating ICH E6 (R3), we promoted educational activities not only for clinical trials but also for clinical trials as a whole by giving lectures and disseminating information at conferences and workshops in cooperation with the government and academia.

With regard to the utilization of DX and AI, we have promoted the organization of issues and the study of solutions through dialogues with medical institutions and related organizations, focusing on DCT (Distributed Clinical Trials), eSource, R-SDV, etc. In particular, we have promoted the promotion of clinical research at the National University Hospital. In particular, through joint discussions with the DX Task of the Council for the Promotion of Clinical Research at National University Hospitals and participation in the System Improvement WG on SaMD, we offered our opinions from the standpoint of the industry.

Regarding the utilization of RWD/RWE, based on the Next Generation Medical Infrastructure Act and other institutional trends, we organized regulatory requirements, visualized utilization issues for pharmaceutical companies, and disseminated information on domestic and overseas case studies. We also worked to foster public understanding of the secondary use of medical information by creating videos and booklets, holding study sessions for the media, and other means.

In the area of pharmacovigilance, we participated in discussions on the design of the RMP system and safety surveillance in anticipation of the revision of the Pharmaceutical Affairs Law, working closely with the JFMA and regulatory authorities. Through the dissemination of guidelines for ordinary safety surveillance activities and discussions on the nature of communication with patients and healthcare professionals, we contributed to the promotion of highly effective and reliable safety measures.

In the area of optimizing conformity assessment, we worked to improve the efficiency of conformity assessment based on a risk-based approach through information sharing and exchange of opinions with the PMDA. In the New Drug, Reexamination, and Non-clinical Investigation WGs, we promoted studies to improve investigation operations and explanatory materials, as well as to enhance international consistency.

In the New Modalities initiative, with regard to regenerative medicine products, the committee worked with the Biopharmaceutical Committee to organize the introduction of RMPs and disseminate reference information on clinical development.

In Asia, in collaboration with the Asia Subcommittee of the International Affairs Committee, we worked to organize issues and build networks in the clinical research and trial environment in the Asian region through meetings and symposiums with related organizations. We also held briefing sessions on the ATLAS and ARISE Asian Clinical Trial Networks to share information with member companies and promote their participation.

In the Patient Public Involvement (PPI/E) activities, we raised issues and made proposals with patient groups and medical professionals toward deregulation of clinical trial information provision and renovation of the jRCT. These activities were a concrete step toward reflecting the patient perspective in drug development and information provision, and achieved a certain level of success in raising awareness among member companies.

Regarding the overseas dissemination of information in Japan, we disseminated information on Japan's regulatory reforms and efforts to improve the drug discovery environment, focusing on drug lag and drug loss issues, at international conferences, including the DIA. We have promoted studies for the development of an information dissemination infrastructure for overseas, and established a foothold for continuous and strategic international dissemination of information in the future.

Drug Evaluation Committee Structure Change

In FY2025, in addition to the usual activities, the committee also discussed changes to the structure of the Drug Evaluation Committee for the year 2026.

Background of the study: The environment surrounding the Drug Evaluation Committee has been rapidly changing due to the increasing sophistication of regulations and the advancement of digital technology, requiring a faster and more flexible response than ever before. On the other hand, the current structure, with six subcommittees and nearly 90 TFs, was prone to duplication of activities/resources and silos, making it difficult for the committee to fully focus on the important issues it should concentrate on. In addition, although expert personnel existed, there was not a sufficient mechanism to continuously develop and cross-functionally utilize their knowledge. In light of these issues, it was recognized that the Drug Evaluation Committee itself needed to rebuild a system and structure that would enable it to focus on the issues it should focus on and produce results on an ongoing basis.
Proposed structure change: The existing technical subcommittees would be dissolved and reorganized into "Task Forces (TFs)," which would be responsible for generating results directly under the Committee, and "Expert Teams (ETs)," which would be responsible for issue exploration, human resource development, information sharing, etc. TFs would be established only for important issues with clear objectives, goals, deadlines, budget, and resources, and the direct involvement of the Committee and its members would enable the Committee to make decisions quickly and efficiently. Direct involvement of the executive officers will enhance rapid decision-making and implementation. On the other hand, the specialized teams will be organized into four specialized units, which will serve as the basis for creating future issues and proposing new TFs through the accumulation of expertise and cross-sectional discussions.
At the same time, the secretariat and the planning and promotion team will be strengthened, which will be responsible for administrative functions such as document management and progress management, and the simplification of rules and thorough information sharing will be promoted to enhance the transparency and productivity of activities. Through these efforts, we aim to create a structure that will enable the committee to maintain a sense of unity and produce valuable results on an ongoing basis, even in a rapidly changing environment.
In addition, the JPMA launched the Project for Strengthening the JPMA in July 2025 as part of its efforts to strengthen the JPMA's foundation, and is considering the establishment of a general incorporated association in FY2026.

2. vision of Drug Evaluation Committee and basic concept of activities for FY2026

The vision of the Drug Evaluation Committee is to raise Japan's drug development environment to a level comparable to international standards and to build an innovative drug discovery and clinical research system through collaboration among industry, government, and academia.
In FY2026, the basic policy of the committee is to quickly establish the new structure and promote efficient and highly professional activities while the entire committee shares the same direction. The basic policy is to promote efficient and highly specialized activities while the entire committee shares the same direction. In particular, the newly established expert teams will serve as a forum for discussions that take advantage of their respective expertise, contribute to the accumulation of knowledge, network building, and the development of expert personnel in the industry, and function as a mechanism for considering opinions and requests collected from individual companies.
2026 activities will be carried out in accordance with JPMA 2035 Vision, Policy Proposals2025, Drug Evaluation Committee Based on the vision and mission, the Drug Evaluation Committee will focus on the themes of activities (TFs) to be accomplished.

3. activity policy and priority items

In FY2026, the committee will organize its activity themes into five priority areas and focus on issues in each area.

1) Improvement of the clinical trial implementation environment through collaboration among industry, government, and academia (Co-Creation)

With the aim of creating an environment in which efficient and high-quality clinical trials can be conducted in Japan, the industry, government, and academia will collaborate to promote solutions to issues such as responding to GCP revisions, standardization of clinical trial procedural forms, implementation of single IRB and FMV, medical data collaboration, and AI utilization.

2) Patient Public Involvement (PPI/E) activities (Co-Creation)

To disseminate and advance PPI/E activities among member companies by establishing a mechanism to deliver information on clinical trials, clinical research, and adverse drug reactions to patients and the public in an easy-to-understand manner, and to reflect patients' opinions and experiences in drug development and evidence generation.

3) Medical DX activities: promotion of utilization of medical information and enactment of medical DX-related laws (Japanese version of EHDS)

To promote the social implementation of medical DX by making policy proposals and providing input to administrative study groups in order to promote the secondary use of medical information and develop a legal system for the Japanese version of EHDS, as well as by sharing examples of RWD utilization and developing data infrastructures.

4) Non-clinical: Optimization of non-clinical evaluations based on the latest technologies

Promote sophistication of non-clinical evaluation methods utilizing the latest DX technologies and alternative methods, reduce the number of animals used, review reliability assurance (GLP, etc.), and make recommendations for non-clinical evaluation corresponding to innovative drugs, aiming to establish a scientific and efficient evaluation system.

5) Optimization of drug safety surveillance (Pharmacovigilance) and communication of appropriate medical information

To improve efficiency and sophistication of drug safety surveillance from development to post-marketing, to promote implementation and utilization of adverse drug reaction reporting, signal management, and RMP systems, and to enhance provision of appropriate medical information to patients and healthcare professionals while also utilizing DX.

4. operational policy (Steering Committee, Task Forces, Specialized Units/Specialized Teams, etc.)

The basis of the management policy is to have all steering committee members participate more deeply and actively in committee activities. Always be aware of the issues to be discussed and recommendations to be made, and respect the roles and intentions of the task forces and specialized teams within the committee, and consider them at the regularly scheduled Steering Committee meetings. In its activities, the committee will always be conscious of whether the outputs are "changing the world for the better. This will help promote public understanding of the activities of pharmaceutical companies and improve health literacy. In addition, we will promote and develop regulatory science by promoting collaboration with other committees within the JPMA and cooperating externally with administrative authorities, forums related to the Drug Evaluation Committee, academic societies, ICH, and other activities.
From FY2026, the Drug Evaluation Committee will divide all task forces into 10 Task Force Groups, each of which will be directly led by an officer of the Committee. Each Task Force will work with other related Task Forces, specialized teams, other committees and external organizations to achieve the defined goals.

Task Force

Specialized Teams

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