Reliability note

Titles and AI summaries are unofficial English monitoring aids, not legal advice or official translations. Each link opens the original Japanese official source, which remains authoritative.

Cabinet Order amending the Pharmaceuticals and Medical Devices Agency Act Enforcement Order

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: 2026-06-24 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · 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. 210 of 2026 amends the Enforcement Order of the Act on the Pharmaceuticals and Medical Devices Agency, an Incorporated Administrative Agency (Cabinet Order No. 83 of 2004). It adjusts related Cabinet Orders in connection with partial implementation of an Act amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other laws. The stated promulgation date is 2026-06-24, and the stated effective date is 2027-05-20.

Business Impact

The Pharmaceuticals and Medical Devices Agency may be affected because its governing Act's Enforcement Order is amended; the metadata does not identify the amended provisions or establish specific effects on pharmaceutical or medical-device businesses.

Recommended Action

Review of the official Japanese source could clarify the amended provisions of the Agency's Enforcement Order and any transitional arrangements associated with 2027-05-20.

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.

  1. 2026-06-24 — Promulgated (instrument recorded by e-Gov Law Search) 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(令和八年政令第二百十号) (this update) Original Japanese source
  2. 2027-05-20 — Effective date stated by e-Gov Law Search 地方自治法施行令、特定複合観光施設区域整備法施行令、独立行政法人医薬品医療機器総合機構法施行令 (this update) Original Japanese source