The Progress and Achievements of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC)

Abstract

PMDA established Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in 2016. This Training Center has been providing the trainings for regulators in Asia and around the world based on the accumulated knowledge and experiences of PMDA. The contents of the trainings are wide ranging from basic to practical. The examples of basic lectures include information necessary to build regulatory capacity in each country/region such as international standards/guidelines, benefit/risk evaluation of the medical products, post-marketing safety measures and so on. The mock Good Manufacturing Practice (GMP) inspection seminars at manufacturing facilities are very practical and provide very valuable experience for GMP inspectors in the world. The PMDA-ATC seminars would promote capacity building and human resource development through trainings, and contribute to universal health coverage through developing a foundation for regulatory harmonization in Asia and around the world. The activities of PMDA-ATC has been recognized and highly evaluated internationally. We would summarize the PMDA-ATC activities and its achievements so far, and describe the approach in the future.