PMDA • Statutes
Pharmaceuticals and Medical Devices Act
Use these cards as the quick start for aligning Japanese submissions with the PMD Act. Each focus area maps to downstream Assyro tasks, so teams can trace requirements through to SOPs and filings.
Product Classifications & Licensing
Summaries for drugs, devices, regenerative medicine products, and the associated marketing authorization pathways.
- Links PMD Act Articles 12–19 to PMDA review tracks and priority review programs.
- Highlights Sakigake and conditional early approval mechanics.
GMP / QMS Ordinances
Context for Ministerial Ordinance No. 169 plus alignment notes against EU GMP Annex 1 and ISO 13485.
- Calls out onsite inspection triggers and remote assessment allowances.
- Outlines CAPA expectations that feed into Assyro quality workflows.
Post-Market Safety & Vigilance
Pharmacovigilance, materiovigilance, and J-GVP requirements including re-examination/re-evaluation timelines.
- Clarifies how electronic reporting (J-CORE) hooks into PMDA monitoring.
- Lists triggers for safety communications and label updates.