Drug Evaluation Committee
Interview with Chairman Nakaji

The Drug Evaluation Committee is a group of experts who support the entire value chain of drug development from technical and regulatory aspects, from basic research before a new drug is created, through clinical trials, approval, and post-marketing. Our mission is consistently "to deliver innovative and highly useful medicines to patients, healthcare professionals, and people around the world faster.

In the past, we were a group of experts leading discussions at ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), supporting drug development in terms of regulations and rules. However, we cannot truly change the world by merely discussing and examining the issues. That is why we have set a new vision of "becoming a group that changes the world for the better through policy advocacy. I feel that this change in mindset, which involves not only incorporating the latest scientific findings and technologies but also connecting them to concrete "social implementation," has greatly changed the quality of our daily activities and output, and has further clarified the role that the committee should play for society.

Currently, the whole country is calling for "strengthening Japan's drug discovery capabilities. It is no exaggeration to say that international competitiveness is in a critical situation as drug lag/loss has become apparent. When we talk about strengthening drug discovery capabilities, we tend to focus on basic research to find the "seeds" of new drugs, but equally important is the process of "clinical development" to nurture those seeds and bring them to the market as soon as possible. However, Japan's clinical development environment is riddled with major challenges.

The most significant cause of this is that the environment surrounding clinical trials (clinical studies) in Japan is very "special and unique" from an international perspective. Although there is no problem when development is conducted only within Japanese rules, this unique Japanese environment has become a major barrier for both foreign and Japanese companies to participate in international clinical trials, especially in the current era of "global development" where clinical trials are conducted simultaneously in countries around the world.

For example, there are still many processes that are valid only in Japan, such as roles that do not originally exist under international rules and complicated cost calculation systems that differ from site to site. These factors complicate procedures and drive up costs, resulting in a significant decline in the international competitiveness of Japan's clinical trial environment.

If this situation continues, Japan may be left behind in the global drug development trend. With this strong sense of urgency, we believe that the most important issue to tackle now is to rebuild Japan's "clinical trial and clinical research ecosystem" to be more efficient and of higher quality, in conformity with international standards.

Fortunately, this recognition of the challenge is shared not only by our industry, but also by the government and academia. Instead of working separately as in the past, the PMDA (Pharmaceuticals and Medical Devices Agency), the Ministry of Health, Labor and Welfare, and university hospitals are now working in unison toward the single goal of strengthening Japan's drug discovery capabilities.

We, the Drug Evaluation Committee, are also playing an important role at the center of this great wave. Specifically, as a pharmaceutical cooperative, we are officially participating in the "Project to Promote the Introduction of a Clinical Trial Ecosystem" led by the PMDA, organizing specific issues from the perspective of companies and discussing solutions together. As the international clinical trial rules, ICH-GCP, are being revised, another important activity of ours is to support the smooth introduction of these new rules in Japan, with the major goal of advancing this domestic introduction to the final stage of international agreement by FY2025.

Furthermore, the understanding and cooperation of the general public is essential for ecosystem reform. In Japan, the terms "clinical trial" and "clinical research" are still not well understood and correct information is not well disseminated. In order to share the importance of clinical trials with society as a whole and to create an environment in which patients can participate in clinical trials with peace of mind, we would like to work together with industry, government, and academia to improve the literacy of the public.

To achieve our mission of revitalizing Japan's drug discovery capabilities and bringing innovative medicines to patients around the world. The Drug Evaluation Committee will continue to mobilize knowledge across the boundaries of the subcommittees to powerfully promote the transformation of the clinical development environment in this country.

The structure and activities of the Drug Evaluation Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ). The Drug Evaluation Committee has also launched "X", which provides information in a timely manner. We encourage you to visit these sites.

The Drug Evaluation Committee's website]
Drug Evaluation Committee | Information from the Committee | Japan Pharmaceutical Manufacturers Association (JPMA)

Drug Evaluation Committee Implementation Structure and Active Task Forces]
Implementation Structure and Active Task Forces | Drug Evaluation Committee | Japan Pharmaceutical Manufacturers Association (JPMA)

Drug Evaluation Committee Official X]
https://x.com/iyakuhinhyouka