PMDA医薬品・医療機器アジアトレーニングセンターについて
Establishment of PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affair

Junko SATO
2017 Regulatory Science of Medical Products  
Recently globalization is promptly advancing in medical product development and its vigilance area. To adapt such circumstance change, Pharmaceuticals and Medical Devices Agency(PMDA) established"PMDA International Strategic Plan 2015"in June, 2015. In the Plan, PMDA declared the establishment of two centers, Regulatory Science Center and Asia Training Center for Pharmaceuticals and Medical Devices Regulatory affairs. On the basis of the Strategic Plan, "Asia Training Center for Pharmaceuticals
more » ... and Medical Devices Regulatory Affairs(PMDA-ATC) "was newly established within PMDA on 1 April, 2016. The purpose of the Training Center is to provide the training for foreign regulators, especially in Asia, in response to the demands made by them by making use of the accumulated knowledge and experiences of PMDA. The content of the training seminar will include basic lectures on information necessary to build regulatory capacity in each country/region, such as benefit/risk assessment of the medical products, pharmacovigilance/medical device vigilance, Good Manufacturing Practice(GMP)inspection and so on. Besides, the Center will provide the programs such as on-site mock inspection in cooperation with actual manufacturing facilities. PMDA will, through the Center, contribute to enhancement and mutual understanding of regulations, and strengthening of cooperation in Asia and other parts of the world.
doi:10.14982/rsmp.7.39 fatcat:klwz4kgad5a5xcrzcxk6y4nyuq