Strengthening Human Capital Development for Clinical Trials to Prepare for Future Health Crises

Task Force for Promoting Pharmaceutical and Medical Device Regulatory Harmonization in Asia, Executive Committee on Global Health and Human Security
2024

In 2019, the Japanese government announced a Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization. The objective of that policy was to improve access to pharmaceuticals and medical devices as a key step to improving health and longevity in Asia. The policy was developed based on recommendations prepared by the Task Force for Promoting Pharmaceutical and Medical Device Regulatory Harmonization in Asia, a group of experts that was formed in December 2018 under the Executive Committee on Global Health and Human Security, organized by JCIE. The Task Force offered recommendations on concrete steps to implement the Grand Design, which were reviewed and adopted by the Liberal Democratic Party of Japan (LDP) as its official party recommendations.

Since then, this Task Force has been conducting follow-up activities on the proposals with the aim of supporting the realization of the Grand Design. Since the Task Force began its work, there has been progress made by the government of Japan on several valuable fronts, such as the formation of world-class R&D hubs for vaccine development, various efforts on digitization, and deliberations at the PMDA toward the establishment of hubs in other countries. Discussions have also been held by the government’s expert panels regarding critical issues for accelerating R&D. In light of the developments above, the Task Force held discussions focused on an area that has not received much attention from the Japanese government to date: namely, what should be done to implement adequate measures, based on a comprehensive and consistent strategy, to develop the necessary research and research support personnel and to maintain and enhance academic research organization functions. This publication outlines their recommendations.

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