Regulatory Revolution in Japan: The New Pathway for “Specific Use Drugs” in 2026
In 2026, Japan is implementing a structural change in its drug designation process. The new workflow allows companies to apply for the “Drug for Specific Use” classification directly to the PMDA (Pharmaceuticals and Medical Devices Agency), eliminating previous ministerial bureaucratic hurdles and accelerating the arrival of treatments for rare and critical diseases in the Japanese market.