Summary
Japan's Pharmaceuticals and Medical Devices Agency sets a phased plan to use AI in its internal operations. The plan adopts existing AI tools for search, summarization, minute‑taking, and translation, and pilots proprietary models in a secure environment for specialized review and safety tasks. It also establishes agency‑wide AI governance.
Healthcare Implications
Regulatory reviews, safety assessments, and inspections in Japan may become faster and more consistent as PMDA verifies these tools. Sponsors should anticipate AI‑assisted workflows during interactions and plan submissions with clearer documentation, traceability, and post‑market evidence.