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. While the National Cancer Center (NCC) and the National Center for Global Health and Medicine (NCGM) have established a network of clinical trial sites with medical facilities in Asian countries in the fields of oncology and infectious diseases, respectively, the task force noted that a number of issues still exist in conducting clinical trials in Asian countries: higher costs to conduct international clinical trials in Asian countries compared to domestic trials; differences in clinical trial support capacity among countries; a lack of clarity in parts of the regulatory and insurance systems; redundant ethical review processes in some countries; complicated requirements for import and export of samples and pharmaceuticals required for clinical trials. The task force has therefore produced a new set of recommendations to address these issues and to apply lessons from the COVID-19 response.