Cabinet Order amending the PMDA enforcement order alongside pharmaceutical law changes
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の一部の施行に伴う関係政令の整備等に関する政令
Published: 2025-10-31 · Source: e-Gov Law Search — Updated Laws · Stage: In Force · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-23
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
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
Cabinet Order No. 362 of 2025 adjusts related Cabinet Orders in connection with partial implementation of an Act amending the law on the quality, efficacy and safety of pharmaceuticals and medical devices and other laws. The listed amendment concerns the Enforcement Order of the Act on the Pharmaceuticals and Medical Devices Agency, Cabinet Order No. 83 of 2004; the stated promulgation date is 2025-10-31 and the effective date is 2026-05-01.
Business Impact
The Pharmaceuticals and Medical Devices Agency may be affected because the listed amendment concerns its governing enforcement order, rather than directly identifying new requirements for pharmaceutical or medical-device businesses.
Recommended Action
Review the official Japanese source for the specific changes to the Agency's enforcement order and any transitional provisions associated with the 2026-05-01 effective date.
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.
- 2025-10-31 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2026-05-01 — Effective date stated by e-Gov Law Search Original Japanese source