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Recommendations on Formulating a Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization: A Four-Wheel Drive Approach to Promoting Regulatory Harmonization in Asia
March 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, a particularly pressing issue in Asia in the face of economic expansion, population increases, and aging societies, as Japan has already experienced. After a series of meetings, recommendations were submitted to the Executive Committee for their review.

The final 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, infrastructure development, and the strengthening of regulatory science (i.e., conducting accurate forecasts, assessments, and decisions based on evidence for the purpose of using the results of science and technology for the people and society).

The recommendations are available in English and Japanese.