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 2018 under the Executive Committee on Global Health and Human Security. This follow-up report by the Task Force offers recommendations on concrete steps to implement the Grand Design. The report was reviewed and adopted by the Liberal Democratic Party of Japan (LDP) as its official party recommendations on May 19.
The report examines and summarizes specific areas that Japan should tackle in order to promote regulatory harmonization and establish infrastructure for clinical development in Asia. Two fields of disease—cancer and infectious diseases—were identified as initial targets, which can serve as a model when expanding to additional fields in the future. The report also encourages greater 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.