Drug Evaluation Committee Held "2025 Annual Meeting of the Drug Evaluation Committee" Drug Evaluation Committee Ecosystem - Overcoming Turbulent Times and Promoting Attractive Activities
December 26, 2025
The 148th General Meeting of the Committee on Drug Evaluation was held on November 21, 2025 at the Nihonbashi Life Science Hub (Chuo-ku, Tokyo). In order to ensure attractive committee activities that respond to changes in the environment, representative members from member companies of the Drug Evaluation Committee gathered at the venue and exchanged opinions on new committee activities in a workshop format. The explanation of the new committee structure and the panel discussion after the workshop were streamed on YouTube and attended by a large number of participants, including those online.
Discussions on "GCP Renovation", the activation of the "Clinical Trial Ecosystem Project", and the advancement of digital technology have led to significant changes in the way clinical trials and other drug evaluations are conducted. In order to respond to these changes in the environment in a more effective, efficient, and timely manner, and to continue activities that create much value, the Drug Evaluation Committee itself must also change. In the first part of this Annual Meeting, the committee executives will explain the policy on the systemic changes they have been studying to realize the "Drug Evaluation Committee Ecosystem." In the second part, the committee will step out of the conventional reporting and sharing-centered format and provide a forum for free discussion in a workshop format for representative committee members from member companies for the first time, In the second part of the meeting, the panel members stepped out of the conventional reporting and sharing format and held a free discussion in a workshop format for the first time. In the third part, a panel discussion was held to share the results of the workshop discussions and foster common understanding.
Part 1: Sharing the purpose of the AGM and the new structure policy
The General Assembly was opened with an announcement by Mr. Yoshitaka Shimizu, Steering Committee Secretary of the Drug Evaluation Committee, who served as the general chairperson. Mr. Yoshinori Yoshida, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), opened the meeting by emphasizing the importance of "co-creation" through collaboration among various stakeholders including government, academia, and industry in order to deliver new pharmaceutical products to patients. Next, Mr. Yoshiyuki Ishida, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), explained the purpose of the meeting. While the activities of the Pharmaceuticals Evaluation Committee and the Pharmaceutical Manufacturers Association of Japan (PMAJ) as a whole are expected to produce results in line with the directions set forth in the "Industrial Vision 2035" and "Policy Recommendations 2025," there was a shared recognition of the issues that have not necessarily led to the desired results, such as the decline in Japan's market attractiveness and international competitiveness. The participants shared this view. In addition, the need for the Drug Evaluation Committee to focus on areas where it can make changes on its own, enhance its ability to make proposals and implement them, and promote co-creation within the Pharmaceutical Manufacturers Association of Japan (PMAJ) was also discussed.
Mr. Shigeru Nakaji, Chairman of the Drug Evaluation Committee, explained the policy of changing the structure of the committee from FY2026. The current committee consists of six subcommittees and three committee task forces, with more than 1,300 members, but the following issues were raised: it is difficult to flexibly respond to changes in the environment, there are issues in terms of productivity and transparency due to duplication of activities and lack of visualization, and expert personnel are not being used more effectively and cross-functionally. The challenges include the inability to utilize specialized human resources in a more cross-functional and effective manner. In light of these issues, the new organization will have "task forces" that can be launched and terminated promptly to resolve issues, and "specialized teams" that handle specialized themes and train highly specialized personnel as its core. The policy of the committee is to create an ecosystem that can respond quickly to changes.
After that, Ms. Ayako Okayasu, Steering Committee Secretary of the Drug Evaluation Committee, reported on the results of the preliminary questionnaire survey on the theme of "What member companies expect from the activities of the Drug Evaluation Committee. The report included the following recommendations: proactive negotiations with the authorities and academia; strengthening of cooperation with other committees, non-member companies, and ventures; visualization of committee activities and results and regular information updates; creation of a mechanism to collect requests from member companies and link them to committee activities; improvement of the IT environment for committee activities to increase efficiency; networking and human resources development centered on young people, which are difficult to achieve by individual companies; and the establishment of a system to provide information on the committee's activities to member companies and their members. The expectations for the committee were summarized, including networking and human resource development, especially for younger members. In addition, the committee introduced candidates for "issues to be prioritized in the future," including responses to "GCP Renovation" and "Clinical Trial Ecosystem Project. In addition, requests for operational improvements were also shared, including the number of surveys to be conducted, advance sharing of committee activity schedules, provision of information prior to member recruitment, and creation of opportunities for next-generation human resource development. The results of these surveys were not merely a list of requests received by the committee, but were positioned as information to clarify the functions and roles that should be prioritized in the design of the new structure, and served as an important premise for the workshops and panel discussions that followed in the second part of the meeting.
Part 2: Workshop: Member companies' expectations and requests for the new structure
In the second part, the Pharmaceutical Evaluation Committee members (representative members from each company) voted on the policy for changing the committee structure and the recruitment of members as a general meeting, which was approved by a majority vote. In addition, a workshop was held on the theme of "What member companies expect from the activities of the Drug Evaluation Committee. Through group discussions, the expectations that member companies have for the new structure and the functions that they expect the committee to perform were organized in concrete terms.
The first expectation of the new structure is that the industry will work together to address the various issues handled by the Drug Evaluation Committee. Expectations were also expressed regarding the role of the newly established "expert team. The importance of systematically resolving issues that are difficult for individual companies to address adequately, such as identifying points that need to be considered in response to changes in the environment, and then developing concrete results through the "task force," was also discussed. In recruiting members, it was suggested that clearly presenting the objectives, expertise sought, and experience to be gained would make it easier for members to decide whether or not to participate, as well as to participate from the perspective of human resource development. Other expectations included improving access to necessary information and deliverables, creating a system in which participating members can feel the benefits of their participation, improving transparency, and eliminating silos.
Regarding the functions expected of the committee, in addition to negotiating with authorities and strengthening cooperation with other organizations, emphasis was placed on the "issue collection and resolution" function, which involves collecting issues that individual companies want to resolve, forming task forces as needed, and sharing the study process and results in an easy-to-understand manner. Expectations were also expressed for the role of sharing information beyond individual companies and tackling common issues in areas such as the enhancement and promotion of utilization of Japan's Real World Data (RWD), "GCP Renovation" and "patient and citizen engagement (PPI/E). They also expressed a desire to share, to the extent possible, the discussion and background behind regulatory notices and Q&A, and to assist in communicating regulatory changes internally and externally without misunderstanding.
Regarding information access and transparency, many expressed the desire for improved access to documents and deliverables in the document management system and for greater visibility of the activities of the Pharmaceutical Manufacturers Association and the various task forces. At the same time, some expressed hope for a reduction in duplicate questionnaires and a coordinating function for efficient industry-wide response, including the status of collaboration with other committees and organizations. With regard to the environment for human resource development and participation, the participants expressed the desire for the creation of an activity environment that is psychologically safe and easy for young people to participate in, and for the active dissemination of concrete results, such as regulatory changes and policy recommendations, so that the value of sending human resources to committee activities can be easily explained within the company. The panelists shared the understanding that the committee's unique approach to human resource development is to have talented personnel from each company experience the process of finding solutions to issues they identify in their daily work through the committee, which will also improve their ability to explain and make recommendations.
Part 3: Panel Discussion: Expectations for new committee activities and future direction
The third part of the panel discussion was chaired by Shigeru Nakaji, Chairman of the Drug Evaluation Committee, and Mitsuhiro Kondo, Steering Committee Secretary, and the panelists were Yukiko Sakakibara, Secretary of the Industrial Policy Committee, Shigeru Fujimori, Vice Chairman of the Drug Evaluation Committee, Takayuki Imaeda, Vice Chairman, Mutsumi Suzuki, Chairman of the Basic Research Committee, and Makoto Miyazaki, Chairman of the Pharmacovigilance Committee. The second part of the meeting was held at the same time. After presentations by each group on their expectations for and awareness of issues related to the Drug Evaluation Committee discussed in the second part, Ms. Yukiko Sakakibara, Secretary of the Industrial Policy Committee, explained about the "Pharmaceutical Strength Project," a functional enhancement measure being promoted by the Pharmaceutical Manufacturers Association of Japan to ensure the realization of the "Industrial Vision 2035" and "Policy Recommendation 2025. He expressed his high expectations for the Pharmaceutical Evaluation Committee, which is taking the initiative in organizational reform to strengthen the activities of the Pharmaceutical Manufacturers Association of Japan (PMAJ). In the plenary discussion, the participants discussed what should be achieved for the new committee activities based on the contents of the project. The main issues discussed included improving the transparency of cooperation and information sharing among the committees, developing human resources through specialized teams and strengthening global dissemination, and establishing a new project management function and a sustainable management system.
Toward the end of the panel discussion, each panelist candidly shared his or her thoughts on the changes to the structure. While the results accumulated through past committee and subcommittee activities are not to be denied, the increasing complexity of issues has made it difficult for one subcommittee alone to provide optimal solutions, and the panelists shared their experiences of being able to create significant change through collaboration with other subcommittees and committees. The importance of redefining the roles of each specialty, including non-clinical areas, in the integrated flow of drug discovery from upstream to downstream, and linking this to policy recommendations and improvements in system operation, was also pointed out. He also pointed out that the policy to change the system that has been discussed so far is still incomplete, and that in order to keep up with the speed of environmental changes, it is necessary to "not only continue discussions, but also to take the initiative in making improvements while running" and that true change will only be realized with the participation of many like-minded members. The message was that true change can only be realized with the participation of many like-minded members. He expressed his hope that the foundation for such a change is growing throughout the committee, and encouraged the committee members to continue to actively contribute their insights and suggestions. Mr. Shigeru Nakaji, Chairperson of the Drug Evaluation Committee, shared his recognition that the feasibility of this system change has further increased through the General Meeting. While there are still many points to be discussed before the finalization of the changes, the key to the success of the changes lies in the active participation of the many members who attended the meeting, who will actively participate in the implementation of the changes by sharing their frank opinions from a positive point of view, he said.
Based on the discussions at the General Assembly, the importance of the Drug Evaluation Committee, as a central player in the drug development ecosystem, to make effective recommendations and implement them in both directions under the direction of "Industry Vision 2035" and "Policy Recommendations 2025" was reaffirmed. Taking the expectations and awareness of issues raised by member companies as a starting point, we will continue our efforts to realize more attractive committee activities under the new structure.
Responsibility: Shigeru Fujimori, Vice-Chairman of the Pharmaceutical Evaluation Committee
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