Pharmaceuticals and Medical Devices Agency
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.
Overview
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.
- New drug and device review
- SAKIGAKE designation
- Conditional and time-limited approval for regenerative medicine
- Post-marketing safety
Similar pages
not linked directly; found by shared links- IsotopeIodine-123
Shares Nihon Medi-Physics, PDRadiopharma.