Act Amending the Pharmaceuticals and Medical Devices Act and Related Laws: Effective May 20, 2027
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律等の一部を改正する法律
Published: 2025-05-21 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-09-16
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AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
This item refers to an amending act relating to the Japanese law on securing the quality, efficacy, and safety of pharmaceuticals, medical devices, and similar products, along with related laws. According to the metadata, it carries the law number Reiwa 7 (2025) Act No. 37, with a promulgation date of 2025-05-21 and a stated enforcement (effective) date of 2027-05-20. The metadata also lists the Health Insurance Act (Taisho 11 Act No. 70) as an affected law in an e-Gov law update listing.
Business Impact
Organizations involved in pharmaceuticals, medical devices, or health insurance-related activities in Japan may be affected and could need to review how the amendments interact with existing obligations. Any operational changes could depend on the specified enforcement date and implementing details not contained in this metadata.
Recommended Action
Consider reviewing the official e-Gov law text and the authoritative Japanese source to confirm the scope, affected provisions, and applicable dates.
Timeline of related official records
Related official records are linked only when names and instrument numbers match exactly, so this timeline may be incomplete. Dates are as stated by the official sources. It is a monitoring aid, not legal advice; the original Japanese sources are authoritative.
- 2025-05-21 — Promulgated (statute recorded by e-Gov Law Search) Original Japanese source
- 2027-05-20 — Effective date stated by e-Gov Law Search Original Japanese source