Meeting with Pharmaceuticals and Medical Devices Agency (PMDA), National Cancer Center (NCC), and National Institute of Health Risk Management (JIHS)" held to improve the clinical trial environment in Asia
The Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and the Asia Subcommittee of the International Committee identify issues that impede the smooth implementation of clinical trials and regulatory harmonization in Asia, and seek solutions through collaboration with the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) and research institutions. As part of these activities, we held a lively discussion with PMDA, the National Cancer Center (NCC), and the National Institute of Health Risk Management (JIHS) in a hybrid face-to-face/online format on April 17, 2025. This is the second time this meeting has been held, having held the first joint industry-academia-government meeting on January 17, 2025 at PMDA's Asia Office.
JIHS
Mr. Daisuke Tokita, Director, International Trials Dept.
Mr. Naoki Tomotsugu, Director, Project Planning & Management Office
Mr. Masato Ichikawa, Director, Project Management Office
He introduced the role of JIHS, which was established on April 1, 2025 through the merger of the National Center for Global Medicine (NCGM) and the National Institute of Infectious Diseases (NIID). Specifically, he talked about the strengthening of the collection and evaluation of infection situations in Japan and abroad, the infrastructure to promote research and development, and the core of the clinical trial network. In addition, he talked about the Alliance for Research on Infectious Diseases in Southeast and East Asia (ARISE), which has been established three years ago and has accumulated experience in conducting clinical research and trials related to infectious diseases, and how, based on this experience, it has established a system for collaboration among its members, has a liaison officer who serves as a bridge between the members and each country, is developing surveillance research, and has established a network of research institutes in each country. In addition, he spoke about the strength of the network in terms of its good relationships with ministries of health, regulatory authorities, and research support organizations in each country.
National Cancer Center
Mr. Kenichi Nakamura, Director, International Development Division
Ms. Chiharu Mizoguchi, Acting Director, Research Planning Office
Mr. Sansho Terada, Director, Office for Promotion of Asian Collaboration
Mr. Yuta Sekino, Director, Thailand Office for Promotion of Asian Cooperation, Office for Promotion of Asian Cooperation
Regarding the NCC-led project to establish a network for Asian cancer clinical trials (ATLAS Project), he talked about the significance of the ATLAS Project, past international collaborative trials, and the development of the network.
He also talked about the future prospects of the project, such as the establishment of a clinical development infrastructure to solve and satisfy clinical issues unique to Asia and the needs of companies, the accumulation of know-how on international joint trials, and the possibility of collaboration not only in Asia but also in the U.S. and Europe.
Mr. Jun Kitahara, Director, PMDA Asia Office
In August 2024, PMDA's first overseas office, the PMDA Asia Office, will be established, and the purpose of establishing this office and the activities that have been conducted since its establishment, including visits to major authorities in Asia, were shared. The PMDA will continue to confirm requests from industry, government, and academia to improve clinical trials, and to support the development of a regulatory environment that facilitates clinical development in Asian countries in order to improve access to innovative drugs and other products in the region.
Pharmaceutical Evaluation Committee and International Committee Asia Subcommittee of the Pharmaceutical Manufacturers Association of Japan
The Pharmaceutical Manufacturers Association of Japan (PMAJ) shared the challenges in conducting clinical trials in Asia and its efforts to address them, as well as its expectations for discussions among industry, government, and academia to improve the efficiency of clinical trials in Asia. In particular, since cooperation with regulatory authorities and medical institutions, as well as harmonization of clinical trial implementation between multiple countries and institutions, are important for efficient and high quality international collaborative trials, they expressed their requests for harmonization activities based on the establishment of cooperative relationships with regulatory authorities and clinical trial networks.
Finally, industry, academia, and government exchanged opinions on each request and discussed future activities. It was confirmed that the committee will continue to exchange opinions on a regular basis and to collaborate with industry, academia and government.
Drug Evaluation Committee: Shigeru Nakaji , Ayako Okayasu
International Committee, Asia Subcommittee: Osamu Kagawa, Noriyuki Fujii, Ryosho Imai, Hiromi Murabayashi, Keiichiro Kondo, Takuya Tone, Keiko Sato