Promoting Pharmaceutical & Medical Device Regulatory Harmonization in Asia

2018–Present

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 15 experts from industry, academia, and government, seeks to formulate recommendations on how Japan could improve access to pharmaceuticals and medical devices in Asia. During the first year, 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 produced in the first year 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.

In the second year of the project (2019–2020), the task force is working to encourage the implementation of the Japanese government’s Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization, which was announced in June 2019 and is intended to improve access to pharmaceuticals and medical devices in Asia. It also seeks to encourage the access to and proper use of  drugs and medical devices by promoting the development of clinical trials and clinical research systems based on the needs of Asian countries, which will allow for data-gathering on clinical trial evidence and such in those countries and for the establishment of a system for reporting adverse reactions once the products are in the market.

In addition to confirming the status of initiatives undertaken by relevant organizations, the task force has created working groups on infectious and noncommunicable diseases to consider the development of clinical trial and clinical research systems, and specific measures are being considered for each disease area.

Year 1 Recommendations
Year 2 Recommendations