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.

Amending Act to the Pharmaceuticals and Medical Devices Act (Act No. 37 of Reiwa 7)

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: Promulgated · 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

The item is an entry in the e-Gov law update list for an Act partially amending the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (Act No. 145 of 1960). The metadata gives the amending Act as Reiwa 7 Act No. 37, with a promulgation date of 2025-05-21 and an update-list date of 2026-10-09. The specific amendments are not described in the provided metadata.

Business Impact

Companies handling pharmaceuticals, medical devices, or related products in Japan may be affected, but the nature and scope of any changes cannot be determined from the metadata alone. The effective dates of individual provisions are not stated in the provided text.

Recommended Action

Review the official Japanese text on e-Gov, including the supplementary provisions on effective dates, to confirm which amendments apply and when.

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 Dashboard page Original Japanese source