PSY6-4 Regulatory aspect of regional collaboration for medical products development in Asia

Abstract

It's been a while since access to medicines and other essential medical products was recognized as one of the important agenda in global health. COVID-19 pandemic has been affecting every parts of the world and never before has international concord to facilitate development and to achieve access to new medical products been requested to tackle this ongoing threat regardless of development stage of each country. Regulatory authorities play a key role to assure quality, safety and efficacy of medical products. ICH and IMDRF composing of regulatory authorities including US FDA, EMA and MHLW/PMDA have long been leading global harmonization activities that minimize regulatory deviation among regulatory authorities and enable to develop medical products on a common ground. APEC's Regulatory Harmonization Steering Committee under the Life Sciences Innovation Forum further promotes it in Asia pacific region, making full use of deliverables of those initiatives. In addition to PMDA's participation in those global and regional initiatives, PMDA has been contributing to implementation of regulatory harmonization and reliance principle by providing training programs to regulators through Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) established in 2016. Moreover, with a recognition that access to medical products particularly in Asian region is essential for the realization of Universal Health Coverage (UHC), which is regarded as an integral part of Japan's contribution in global health, the Headquarters for the Healthcare Policy of Japan approved the Grand Design for Asian Pharmaceutical and Medical Devices Regulatory Harmonization in 2019 aiming at concretizing regulatory harmonization to contribute to the health of people in Asia. In accordance with the Grand Design, PMDA reorganized Office of International Programs and further contributes to regulatory harmonization in Asian region through multi- and bilateral cooperation.