Ministerial Ordinance amending pharmaceuticals and medical devices regulations

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

Ministry of Health, Labour and Welfare Ordinance No. 142 of 2026 was promulgated on 2026-09-30, with a stated effective date of 2027-05-20, to adjust ministry ordinances in connection with partial implementation of an Act amending pharmaceuticals and medical devices legislation. It amends the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Ministry of Health and Welfare Ordinance No. 1 of 1961).

Business Impact

Businesses handling pharmaceuticals, medical devices and other products governed by the named Act may be affected by changes to its enforcement regulations, although the supplied information does not identify the amended requirements.

Recommended Action

Review the official Japanese ordinance for the amended provisions, their scope and any transitional arrangements associated with the stated effective date.

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. 2026-09-30 — 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厚生労働省関係省令の整備等に関する省令（令和八年厚生労働省令第百四十二号） (this update) Original Japanese source
2. 2027-05-20 — Effective date stated by e-Gov Law Search 保険薬局及び保険薬剤師療養担当規則、再生医療等の安全性の確保等に関する法律施行規則、医療機器の製造販売後の調査及び試験の実施の基準に関する省令、医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令、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 ほか9件 (this update) Original Japanese source