biomarker regulatory entity Japan’s Pharmaceuticals and Medical Devices Agency https://www.pmda.go.jp/english/about-pmda/outline/0005.html https://www.pmda.go.jp/english/ https://pubmed.ncbi.nlm.nih.gov/29110507/ PMDA The Japanese Pharmaceuticals and Medical Device Agency Pharmaceuticals and Medical Devices Agency (PMDA) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. Conduct 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.