Drug Evaluation Committee

Priority Issues

The most important activities of the Drug Evaluation Committee are, first of all, the establishment of a clinical trial and clinical research ecosystem and the domestic implementation of GCP Renovation in clinical trials and clinical research in order to strengthen drug discovery capabilities and eliminate drug lag/loss in Japan. In light of the increasing opportunities for patients and citizens to participate in the development of healthcare, and the fact that the pharmaceutical industry has taken up this issue as an important issue, it is considered necessary to coordinate PPI activities conducted by each specialized subcommittee and committee task force (TF) within and outside the committee, and to organize more efficient activities by the Pharmaceutical Manufacturers Association of Japan (PMAJ) as a whole. The committee also needs to work together with the other subcommittees and task forces within and outside of the committee to make the activities of PPI more efficient. Another issue in the non-clinical field is to make appropriate proposals from the industry's perspective in response to the revision of the Animal Welfare and Control Law. This law is revised every five years, and the two main points of contention for next year's revision are "making the 3Rs (replacement, reduction, and reduction of suffering in animal testing) mandatory" and "making pharmaceutical companies Type 1 animal handling companies (mandatory). If these are included in the amendment, animal testing will be greatly affected. Therefore, the Pharmaceutical Manufacturers Association of Japan (PMAJ) needs to cooperate with related organizations and provide appropriate opinions for future amendments.

The committee's activity plan for FY2025 includes the following 10 priority themes, and the committee's goal is to promote "strengthening Japan's drug discovery capabilities" and contribute to improving the health of people worldwide by conducting activities and making policy recommendations related to innovative technologies and methods. GCP including ICH E6 R3 This was an important year for promoting the domestic implementation of clinical trials and clinical research in Renovation, and the more important themes were (1) promotion of the establishment of clinical trials and clinical research ecosystem and (2) regulatory compliance with the ICH-GL Clinical Research / Pharmaceutical Affairs Law revision.

Initiatives

The Drug Evaluation Committee will be divided into the Basic Research Subcommittee, Clinical Evaluation Subcommittee, Pharmacovigilance Subcommittee, Data Science Subcommittee, Electronic Information Subcommittee, and Medical Affairs Subcommittee to address issues in accordance with the committee's implementation plan and by utilizing their respective expertise.

In addition to the two task forces that have been continuing since last year, the Task Force for the Promotion of Medical Information Database Utilization and the Task Force for the Study of Digital Transformation (DX), the Committee will establish a new Task Force for the Study of GCP Renovation/Clinical Trials and Clinical Research Ecosystem in FY2025. In addition to the two Task Forces, the "GCP Renovation / Clinical Trials and Clinical Research Ecosystem Study Task Force" will be newly established in FY2025 and will be responsible for (1) promotion of the establishment of the clinical trials and clinical research ecosystem and (2) ICH-GL clinical research / regulatory compliance with the revision of the Pharmaceutical Affairs Act, among the 10 priority activity themes of the Drug Evaluation Committee.

In both task forces, in principle, a lead subcommittee or a steering committee member will be designated to handle these activities on a cross-subcommittee basis, and activities will be conducted in cooperation with other committees and external organizations to conduct research surveys, formulate policies, and make policy proposals to the government. The activities of each committee task force are as follows

Task Force for Promotion of Utilization of Medical Information Databases

Continuing from the previous fiscal year, the following activities will be promoted to promote RWD utilization.

1) Lobbying for appropriate updating of regulatory requirements

Although the Next Generation Medical Infrastructure Act has been revised, the utilization of RWD has not yet been promoted, and we believe that further efforts to update the regulatory requirements and to promote the utilization of RWD are necessary to achieve active utilization. More specifically, we are seeking to realize a "Japanese version of the EHDS" as a "special law" for the utilization of medical information, based on the European Health Database (EHDS) in the EU. The activity plan includes the preparation of materials for negotiations on the use of the EHDS as a back-office for the Industrial Policy Committee's activities as a lobbying group, including the situations in which the people in charge of practical matters think it should be used, the world view to be gained from it, and the embodiment of the benefits to be gained. He is also involved in writing proposals prepared by Keidanren (Japan Business Federation) and the government's policy.

(2) Establishment of infrastructure for RWD utilization

With the revision of the Next Generation Medical Infrastructure Act, the use of the Next Basic Act DB, which links multiple medical data, and the Receipt Information and Specific Health Examination Information Database (NDB), which can be linked to various public DBs, etc., is being legally established, but the infrastructure still needs to be developed to actually make it work.

3) Contribute to the support and development of RWD users

Even if the infrastructure for RWD is established, it will not work properly if there is a lack of human resources who can use it appropriately. The TF plans to translate useful instruction manuals and foreign literature and hold workshops on issues common to each phase, while also coordinating with the training and workshops conducted by each subcommittee.

4) Gain empathy from society regarding the utilization of RWD

As seen in the confusion over the MyNa insurance card, there is still not enough support in Japan for the secondary use of one's own medical data due to a sense of resistance to the leakage of personal information. Appropriate secondary use of medical data advances medical science and creates and optimizes the value of pharmaceutical products. As activities to promote the significance of this issue, we will produce booklets and videos, and continue activities to increase the number of supporters from society using the number of accesses as a process indicator. We are also considering implementing a media strategy to support a cycle in which articles with more appropriate tone are written and read by a large number of people from behind the scenes.

5) Collaboration with related organizations and stakeholders

The number of stakeholders who are positive about the use of RWD is steadily increasing. At the request of the Ministry of Health, Labour and Welfare (MHLW), the Cabinet Office, the Next Generation Infrastructure Policy Institute (NFI), and other organizations involved in certified pseudonym processing, as well as the National Institute of Health, Labour and Welfare (NIHL) and the Japan Agency for Medical Research and Development (AMED), the TF will cooperate in research by sending personnel and contributing to joint writing, lectures and symposium planning. The TF will also appeal the importance of RWD utilization to medical professionals and pharmaceutical-related companies by presenting symposium plans to related academic societies.

Task Force to Study Digital Transformation (DX) 3.

Advances in digital technology have greatly influenced the activities of the pharmaceutical industry, and DX is one of the important focus areas for the entire Pharmaceutical Manufacturers Association of Japan (PMAJ), as well as for our own Drug Evaluation Committee. In this task force, we will broaden the scope to include not only patients but also the public, and continue to examine what issues exist and what further solutions can be provided to contribute to the improvement of their health. Regarding programmed medical devices, they are expected to contribute not only to medical care as a therapeutic aid or treatment, but also to early detection of diseases and intervention in the unaffected stage. In addition, the use of AI/machine learning is advancing at a dramatic pace, and we will gather information on its impact on the activities of our Drug Evaluation Committee, as well as promote committee-wide discussions on what should be implemented. In addition, many other activities related to DX are being developed in each specialized subcommittee of the Drug Evaluation Committee as well as in the entire Pharmaceutical Manufacturers Association of Japan (PMAJ), and since there are a wide variety of related specialized fields, we will promote discussions through organic linkage with the specialized subcommittees within the Drug Evaluation Committee and other committees as well. In response to the environmental changes sweeping through the pharmaceutical industry, the committee will study and disseminate information in order to envision and realize a new world.

GCP Renovation / Clinical Trials and Clinical Research Ecosystem Compliance Study Task Force

Following the revision of E8(R1) in 2022, the E6(R3) Principle and Annex 1 will reach Step 4 in 2024, and Annex 2 will reach Step 2, and domestic public commenting has begun. The implementation of E6(R3) in Japan will accelerate drug development and the creation of medical evidence through the implementation of new types of clinical trials utilizing a wide variety of data sources under the concept of a risk proportionate approach. On the other hand, in Japan, the drug loss problem and the vulnerability of drug and vaccine development due to the coronary disaster have become apparent, and one of these factors is the inefficient clinical trial environment unique to Japan.

In order for Japan to become a country that conducts clinical trials on par with Europe and the U.S., it is necessary to develop an environment in which clinical trials can be conducted effectively and to steadily implement the E6(R3) concept. In addition, efforts to improve the environment, including the Clinical Trial Ecosystem Project, are underway as a national project.

The Drug Evaluation Committee will also launch a cross-divisional study task force to promptly address issues related to GCP Renovation and the clinical trial/clinical research ecosystem, and will study and disseminate the results.

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