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.

Act Amending the Pharmaceuticals and Medical Devices Act and Related Laws (Act No. 37 of 2025)

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: 2026-10-10

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

This e-Gov law-update entry lists an amending act, Act No. 37 of Reiwa 7 (2025), that amends the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and related laws. The entry shows a promulgation date of 2025-05-21 and an enforcement date of 2027-05-20, and identifies the Act on the Pharmaceuticals and Medical Devices Agency (Act No. 192 of 2002) as the law concerned in this update. The substance of the amendments is not described in the provided metadata.

Business Impact

Companies involved in pharmaceuticals or medical devices may be affected once the amendments take effect, although the specific changes cannot be determined from this metadata. The scope and nature of any impact are unknown without the amendment text.

Recommended Action

Review the official Japanese text of the amending act and the linked e-Gov page to confirm the actual amendments and their enforcement dates, and consult qualified counsel as appropriate.

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. 2025-05-21 — Promulgated (statute 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(令和七年法律第三十七号) (this update) Original Japanese source
  2. 2027-05-20 — Effective date stated by e-Gov Law Search 健康保険法、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、地方自治法、武力攻撃事態及び存立危機事態における捕虜等の取扱いに関する法律、武力攻撃事態等における国民の保護のための措置に関する法律 ほか5件 (this update) Original Japanese source