December 18, 2025
Japan Clinical Trials Unlocked: PMDA Pre-Consultation to First Patient In
Editor’s Note Japan represents one of the world’s largest pharmaceutical markets. Its regulator Pharmaceuticals and Medical Devices Agency (PMDA), now targets ~12-month review timelines, with median NDA approval taking roughly 333 days (~11 months). Entering the Japanese market requires understanding the Clinical Trial Notification (CTN) system—distinct from the U.S. IND pathway—and engaging early with the [...]
hNPC01 Fast Track Designation by FDA
As the project partner, BLA congratulates Hopstem Therapeutics on receiving FDA Fast Track Designation for hNPC01 injection– the global first-in-class...