Approval programs & pathways
3 programs · 3 pathwaysExpedited / special pathways
SAKIGAKEPriority ReviewConditional ApprovalOrphan Drug
SAKIGAKEExpedited
Priority designation for innovative products developed first in Japan.
Eligibility · World-first / Japan-first innovation
Conditional ApprovalConditional
Conditional & time-limited approval for regenerative medical products.
Eligibility · Regenerative product + probable efficacy
Priority ReviewExpedited
Shortened review for high-medical-need products.
Eligibility · Serious disease + high medical need
Submission pathways · illustrative timelines & fees
CTA1 mo
Biologics · Agency fee
Clinical Trial Notification to start trials in Japan.
NDA12 mo
Small molecules · Agency fee
J-NDA marketing application reviewed by PMDA / approved by MHLW.
Orphan drug application3 mo
Rare diseases · Reduced
Orphan designation (<50,000 patients in Japan).