Introduction to Japan’s New Drug Development Initiative
According to the news (FIH試験体制整備、29年度稼働目指す 世界の創薬シーズ呼び込む構想、厚労省 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on Sep/04/2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) has recently announced an ambitious project aimed at establishing a state-of-the-art facility for First-In-Human (FIH) trials, which also includes Good Manufacturing Practice (GMP) compliant drug production capabilities and comprehensive research infrastructure. This new project, incorporated into the 2025 fiscal budget request as a ¥790 million initiative, reflects the ministry’s multi-year plan to bolster Japan’s drug development ecosystem. The ministry aims to complete the “specification design” of the facility by 2025 and have the FIH trial center operational by 2029.
Phased Approach to Facility Development
According to MHLW’s clinical trial promotion division, the primary focus for 2025 will be the detailed design of the FIH trial center. This phase involves determining the physical layout, functional roles, and necessary human resources to ensure the facility meets global standards for early-phase clinical trials. The ministry plans to move forward with construction in 2028, setting a target for the facility’s launch in 2029. The vision behind this center is to create a hub not only for Japanese drug development but also to support international pharmaceutical companies by fostering innovative drug candidates, thereby attracting more global collaborative trials to Japan.
A One-Stop Service for Consultation for International Clinical Trials
In addition to the FIH facility, MHLW has included in its budget request a separate initiative: the “One-Stop Consultation Center for International Clinical Trials” (¥270 million). This center will be a gateway for foreign biotech firms, especially those without a local presence in Japan, to navigate Japan’s regulatory landscape and healthcare environment. Positioned within the National Center for Advanced and Specialized Medical Care, the center will offer English-language consultations, helping engage overseas companies with appropriate Japanese medical institutions for clinical development programs. This initiative addresses a common challenge overseas ventures face: the lack of familiarity with Japan’s regulatory processes. The consultation hub will offer a preliminary exchange of information on trial feasibility, such as potential patient populations and trial site capabilities. Even companies not yet committed to conducting trials in Japan can seek advice through remote means such as phone, email, or virtual meetings. The goal is to reduce entry barriers and stimulate more clinical development activity within Japan.
Support for Global Drug Development
The head of MHLW’s clinical trial promotion office, Yasuo Iimura, emphasized that these new initiatives position Japan as a pivotal player in global drug development. By investing in cutting-edge FIH trial capabilities and offering streamlined support for international clinical trials, Japan aims to increase its attractiveness as a destination for innovative research and drug development.
Through these efforts, MHLW hopes to build stronger international collaborations, enhance Japan’s reputation in the pharmaceutical sector, and support the growth of domestic and global drug pipelines.