Pharmaceuticals and Medical Devices Agency

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.