Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s State Food and Drug Administration (SFDA) co-hosted a symposium at the end of May on Global Clinical Trials and Ethnic Factors. The conference facilitated discussion between the two countries concerning their participation in programs for international clinical development. The symposium addressed ethnic factors pertaining to multi-regional clinical trials and promoted the advancement of such trials in China and Japan.
Dr. Tatsuya Kondo, Chief Executive of the PMDA, stressed the importance of collaboration between the two countries in his keynote speech. He recommended building upon each other’s ‘dynamism’ and creating an East Asian medical device/drug community to relay its innovations to the rest of the world.
While efforts at regulatory harmonization have been a solid first step for Asian countries, Dr. Kondo advocated seeking further opportunities to share experiences and ideas amongst Asia’s medical communities, to network, collaborate, and develop ‘best-fit’ drugs for Asian populations.
He also presented several key issues for the realization of the PMDA’s goals, namely, the importance of timely discussion between pharmaceutical and medical device industries and regulatory agencies, the inclusion of Asia in multi-regional drug development, as well as further collaboration and harmonization amongst regulatory agencies. Dr. Kondo took it upon himself to ensure the creation of ‘high-level’ Japanese regulatory criteria which would be held to international standards.