Summary
Establishes a phased plan for secure use of AI in PMDA operations, beginning with search, summarization, meeting records, and translation and extending to pilots for specialized review and safety work, supported by agency-wide governance.
Healthcare Implications
Sponsors may increasingly interact with AI-assisted regulatory review and safety workflows and should submit clear, structured, and traceable evidence. PMDA retains accountable human oversight while evaluating whether AI can improve the consistency and efficiency of reviews and post-market activities.