2024 Volume 41 Issue 3 Pages 405-409
The pharmaceuticals and medical devices agency (PMDA) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. PMDA conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post–marketing safety. PMDA is also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
PMDA is an incorporated administrative agency with non–civil service status established in 2004, and the comprehensive risk management carried out through these three functions is known as the “Safety Triangle,” and is a unique system unparalleled in the world. To play key roles appropriately, it is essential to consider the latest knowledge backed by clinical experience, and PMDA has approximately 50 to 60 medical doctors always working.
On the other hand, in academia, planning and implementing clinical trials for the purpose of developing pharmaceuticals, etc. requires knowledge and experience regarding safety measures and assessments of compliance with the good laboratory practice (GLP), good clinical practice (GCP), and good post–marketing study practice (GPSP), in addition to reviews of pharmaceuticals, medical devices, and regenerative medicine products.
PMDA is the only organization in Japan that can perform these tasks, and therefore, PMDA is the only organization in the country that can offer the experience and knowledge necessary for a career in the field of clinical trials. PMDA has been promoting personnel exchanges of medical doctors from universities and medical institutions that promote clinical trials to PMDA.
PMDA is looking for highly motivated physicians and surgeons who will work together to achieve its mission of “4 Fs” : Patient First, Access First, Safety First, and Asia First. If you are interested, please consider working at PMDA.
