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Task Force for Promoting Pharmaceutical and Medical Device Regulatory Harmonization in Asia

2018–2019

In 2018, JCIE’s Executive Committee on Global Health and Human Security created a Task Force for Promoting Pharmaceutical and Medical Device Regulatory Harmonization in Asia. The group, comprised of fifteen experts from industry, academia, and government, sought to formulate recommendations on how Japan could improve access to pharmaceuticals and medical devices in Asia. Over a period of three months, the task force held a series of discussions on a grand design for regulatory harmonization and relevant matters, which it then submitted to the Executive Committee.

Japan has committed to promoting universal health coverage (UHC) as part of its contribution to the global health field. In other Asian countries, however, the access to pharmaceuticals and medical devices—including products that utilize innovative technologies—is insufficient, posing a serious issue to that objective. Improving access to quality drugs and medical devices is a particularly pressing issue in Asia in the face of economic expansion, population increases, and aging societies.

The recommendations stress the need for Japan’s government, industry, academia, and civil society to work together with neighboring Asian countries and regional partners to promote not only regulatory harmonization but also human-resource development for regulatory authorities and infrastructure development. These recommendations were instrumental in the drafting of the Liberal Democratic Party’s official party recommendations on pharmaceutical and medical device regulatory harmonization, which were announced on March 15, 2019.