{"entity":{"id":"pmda","kind":"institution","name":"Pharmaceuticals and Medical Devices Agency","aka":["PMDA","独立行政法人医薬品医療機器総合機構"],"tldr":"Japan's drug and device review agency, which works with the health ministry to approve cancer drugs and has largely closed the historical 'drug lag' with the US and Europe.","summary":"Established in 2004, the PMDA conducts scientific review of new drugs, devices and regenerative medicine products, with final approval by the Ministry of Health, Labour and Welfare. It introduced the SAKIGAKE fast-track designation, conditional early approval for regenerative medicines, and the Orphan and Conditional approval pathways, and it has been a full participant in ICH harmonisation. Japan approved many antibody-drug conjugates and targeted lung cancer agents at or near the same time as the FDA, and its requirements for Japanese patient data shaped global trial designs. The PMDA also runs post-marketing safety surveillance and the relief system for adverse drug reactions.","asOf":"2026-09-09","links":[{"label":"PMDA","url":"https://www.pmda.go.jp/english/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["adc","photoimmunotherapy"],"targets":[],"drugs":["trastuzumab-deruxtecan","osimertinib"],"companies":[],"institutions":["ncc-japan","jsmo","fda-oce","ema"],"pathways":[],"terms":[],"trials":[],"people":["yasuhiro-fujiwara"],"bottlenecks":["b-regulatory-fragmentation","b-global-access"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Tokyo","country":"JP","lat":35.674,"lng":139.762,"institutionType":"government","website":"https://www.pmda.go.jp/english/","programs":["New drug and device review","SAKIGAKE designation","Conditional and time-limited approval for regenerative medicine","Post-marketing safety"]},"route":"/institutions/pmda/","neighbours":{"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"photoimmunotherapy","kind":"technology","name":"Photoimmunotherapy & photodynamic therapy","route":"/technologies/photoimmunotherapy/"}],"drug":[{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"},{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"institution":[{"id":"cdisc","kind":"institution","name":"Clinical Data Interchange Standards Consortium","route":"/institutions/cdisc/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"},{"id":"jsmo","kind":"institution","name":"Japanese Society of Medical Oncology","route":"/institutions/jsmo/"},{"id":"ncc-japan","kind":"institution","name":"National Cancer Center Hospital","route":"/institutions/ncc-japan/"}],"person":[{"id":"yasuhiro-fujiwara","kind":"person","name":"Yasuhiro Fujiwara","route":"/people/yasuhiro-fujiwara/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}],"term":[{"id":"ich-gcp","kind":"term","name":"ICH good clinical practice (E6)","route":"/terms/ich-gcp/"},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/"},{"id":"sakigake","kind":"term","name":"Sakigake designation (Japan)","route":"/terms/sakigake/"}]}}