What Japan Pharmaceutical and Medical Device Act (PMDA) - Drug Approval: Clinical Trial Notification, PMDA Consultation, Approval Review, Manufacturing Site Registration, GMP Conformity Assessment and Post-Marketing Vigilance requires
This regulation governs the approval pathway for pharmaceuticals in Japan, requiring clinical trial notifications, PMDA consultation, manufacturing site registration, GMP conformity assessment, and post-marketing safety vigilance. Key obligations are derived from PMDA safety updates and review procedures as of April 2026, including revisions to precautions for infliximab and biosimilars.
Pillar: Pharmaceuticals & Life Sciences · Authority: Pharmaceuticals and Medical Devices Agency (PMDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.pmda.go.jp/english/index.html
SHA-256 integrity: cc7684e6942c4998adf740099739f1311f22906f1db3d2651126e41579920eb1
Primary Citations — 5 traced to source
- Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted April 20, 2026
- MHLW Pharmaceuticals and Medical Devices Safety Information No.428 posted April 14, 2026
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