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. 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. These activities were originally intended to address a wide range of diseases, but in light of the COVID-19 pandemic, they shifted their focus. Particularly given the rapid emergence of variants of the virus, the committee views it as urgent that Japan establish the technological infrastructure as well as vaccine production capabilities, and that it establish an innovative evaluation method and an international clinical development system in international harmony.
These recommendations call for even greater efforts to achieve regulatory harmonization in the fields of pharmaceuticals and medical devices and to establish the infrastructure for clinical development. Moreover, with regard to measures to develop domestic vaccines, the Task Force has formulated a COVID-19 Emergency Response Strategy based on the perspective of regulatory science that aims for scientific rationality and societal harmonization. The recommendations were originally released in Japanese on May 11, 2021, and formed the basis for the Liberal Democratic Party’s emergency strategy on Asian pharmaceutical and medical device harmonization announced the following week.