Amending Act to Pharmaceuticals and Medical Devices Act (PMDA Act update entry)

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 e-Gov law-update list entry for the Pharmaceuticals and Medical Devices Agency (PMDA) Act (Act No. 192 of 2002). It records that this Act is affected by an amending act, Act No. 37 of Reiwa 7 (2025), which amends the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. and related laws, with a promulgation date of 2025-05-21. The listed update date is 2026-10-09.

Business Impact

Companies in the pharmaceutical and medical device sector may be affected if the amendments change regulatory requirements, although the provided metadata does not describe the substantive changes or which provisions apply. The effective dates of individual provisions are not stated in the supplied text.

Recommended Action

Review the official Japanese text on e-Gov to confirm the scope of the amendments, which provisions affect the PMDA Act, and their effective 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.

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