Japan aims to realize "Universal Health Coverage (UHC)" as a contribution in the international health field. In order to realize UHC, it will be essential to disseminate all basic services such as infectious disease control and non-infectious disease control, and to respond to the need for prevention, diagnosis and treatment of diseases associated with changes in lifestyle and aging. However, in Asian countries/regions, access to pharmaceuticals and medical devices, including products utilizing innovative technologies, is insufficient, and this is one of the important issues. Under these circumstances, international harmonization is considered to play an important role in improving access to pharmaceuticals and medical devices in Asia. To this end, the Headquarters for Healthcare Policy of Japan developed the Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization for regulatory harmonization and related matters on June 20, 2019 under the Asian Health and Wellbeing Initiative.