MHLW Ministerial Ordinance Amending Enforcement Regulations of the Pharmaceuticals and Medical Devices Act

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 e-Gov law update list shows a ministerial ordinance (Reiwa 8 MHLW Ordinance No. 139) amending the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Showa 36 MHLW Ordinance No. 1). The metadata lists a promulgation date and an effective date that are both 2026-09-16, and the update list date as 2026-10-07. The provided metadata does not describe the substance of the amendments.

Business Impact

Because the content of the amendments is not given, the impact is unclear; companies handling pharmaceuticals or medical devices may be affected in areas governed by these enforcement regulations. The preliminary 'Medium' impact label is keyword-based and not a verified assessment.

Recommended Action

Review the official Japanese text of the amending ordinance at the e-Gov source to identify which provisions changed and whether they are relevant to your operations.

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. 2026-09-16 — 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施行規則の一部を改正する省令（令和八年厚生労働省令第百三十九号） (this update) Original Japanese source
2. 2026-09-16 — Effective date stated 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施行規則 (this update) Original Japanese source